#contract drug manufacturing organization

[healthpulsetoday]

Top CDMO Companies Shaping the Future of Pharmaceutical Manufacturing

Contract development and manufacturing organizations (CDMOs) play a significant role in the pharmaceutical industry by providing end-to-end services for drug development and manufacturing. CDMOs provide various services ranging from drug discovery, development, formulation, clinical trials, and commercial manufacturing. According to DelveInsight Business Research, the global pharmaceutical contract manufacturing market is expected to reach $146.36 billion by 2025, with a CAGR of 6.5% from 2020-2025.

There are several reasons why pharmaceutical companies opt for CDMO services. One reason is to save time and money. Outsourcing the development and manufacturing process to a CDMO allows pharmaceutical companies to focus on their core competencies while reducing operational costs. Additionally, CDMOs have specialized expertise in drug development and manufacturing, which results in higher-quality products.

The CDMO market is highly competitive, with several key players dominating the market. Some of the top CDMO organizations include Catalent, Lonza, Thermo Fisher Scientific, Patheon, and Boehringer Ingelheim. These companies offer end-to-end services, including drug development, formulation, clinical trials, and commercial manufacturing. Other notable CDMOs include Samsung BioLogics, WuXi AppTec, and AbbVie Contract Manufacturing.

In recent years, there has been a significant increase in demand for biotech contract manufacturing services. Biotech companies require specialized services due to the complexity of their products. CDMOs that specialize in biotech contract manufacturing include AGC Biologics, Rentschler Biopharma, and Cytovance Biologics.

The CDMO market is highly competitive, with several key players dominating the market. Here are the top CDMO companies in 2023, according to DelveInsight Business Research:

Catalent

Lonza

Thermo Fisher Scientific

Patheon

Boehringer Ingelheim

Samsung BioLogics

WuXi AppTec

AbbVie Contract Manufacturing

AGC Biologics

Rentschler Biopharma

CDMOs play a critical role in drug development and manufacturing. The services they offer allow pharmaceutical companies to focus on their core competencies while reducing operational costs. With the increasing demand for biotech contract manufacturing services, the CDMO market is expected to grow significantly in the coming years.

In conclusion, CDMOs are essential in the pharmaceutical industry, providing end-to-end services for drug development and manufacturing. The CDMO market is highly competitive, with several key players dominating the market. The increasing demand for biotech contract manufacturing services is expected to drive the growth of the CDMO market in the coming years. If you are looking for a pharmaceutical contract manufacturing company or a contract drug manufacturing organization, you can refer to the top CDMO companies list to choose the right organization for your requirements.

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[cdmoservices]

Pharma API Manufacturing Sites & Capabilities | CDMO Company | CRO | Aurigene Pharmaceutical Services

We operate 8 API manufacturing sites. Each of these sites has a dedicated facilities associated with capacity, capability, desired market, & appropriate regulatory status.

To know more:https://www.aurigeneservices.com/services/manufacturing/sites-and-capabilities

[sentisspharma]

A niche pharmaceutical company committed to provide the best quality Ophthalmic, Inhalation (for nebulization), Otic and Nasal drops since its inception in 1990. Sentiss is recognized as a Great Place to Work in India for 7 years* in a row. Sentiss is committed to serve and build a stronger society through its social responsibility “SEVA” initiatives with main focus on health, education and environment.

https://sentisspharma.com/

[mysticalcrowntyphoon]

Rising cases of gestational diabetes necessitate increased availability of anti-diabetic medication in the market: CDMO to the rescue.

Table of content

General Introduction

Akums Drugs and Pharmaceuticals Ltd.

Gestational Diabetes Mellitus

Part of CDMOs.

General Introduction

Living with diseases becomes a roller coaster ride for anyone. It requires extensive care and well-formed medications to cure or minimize its effect. Medications remain an integral part of human life. They help to survive and extend life expectancy time as well. Preparation of medications goes through different crucial stages which need consistent monitoring under skilled professionals and world-class infrastructural and equipment support. When evaluating all these basic and advanced requirements in the field of pharmaceuticals, one name which comes to light is Contract Development and Manufacturing Organizations (CDMOs).  

 Akums Drugs and Pharmaceuticals Ltd.

 CDMOs are well aware of their roles and responsibilities. The services, facilities, and products created by them are exemplary and cater to the highest quality levels. They possess all the basic to advanced support to offer the mankind best of their capabilities. One successful name in the field of the same is Akums Drugs and Pharmaceuticals Ltd. Serving this industry for more than two decades they have proven as one of the pillars of the pharmaceutical Industry.

 Gestational Diabetes Mellitus

Gestational diabetes Mellitus can be defined as glucose intolerance that generally happens to pregnant women during or onset of pregnancy. There are many factors associated with the same like nongenetic factors, maternal age, diet, and lifestyle. There are many effects of gestational diabetes mellitus ranging from asymptomatic, increased risk of pre-eclampsia, macrosomia to neonatal hyperglycemia. These effects can target both mother and the fetus. The reports suggest that approximately seven percent of pregnancies get complicated by GDM which is now a global health concern. The situation needs to be controlled and urgently required harmless and effective oral medications for women with GDM. Even though lifestyle changes and insulin therapy prove helpful yet oral medications are required to keep the condition under control during this ailment.

Part of CDMOs.

CDMOs are experts in their field who have the expertise to create the best to offer to mankind. Even in the case of GDM, they have proven themselves significant by producing secure and efficient oral anti-diabetic medications. They keep on exploring all the prospects to bring out the best and in course of that they keep on doing researches and development efforts to explore and assess novel medications that can be used for treating GDM. Their efforts are quite evident in offering safe and quality drugs as they keep on streamlining the manufacturing procedures to manufacture oral anti-diabetic medications. They follow the set safety procedures with complete compliance to get their drugs approved and authenticated by the required highest standards. Their working with medical professionals and regulatory organizations remains integral in their endeavors.

Akums Drugs and Pharmaceutical Ltd. is completely dedicated to the prevention and cure of ailments and keep on exploring the expected possibilities. It remains attentive to getting the latest and updated version of the therapeutic measures so that the vision to serve mankind efficiently can be materialized well through its consistent efforts.

Key Takeaways

· When evaluating the best and catering to all the basic or advanced requirements in the field of pharmaceuticals, one name which comes to light is Contract Development and Manufacturing Organizations (CDMOs).  

·Akums Drugs and Pharmaceutical Ltd. is completely dedicated to the prevention and cure of ailments and keep on exploring the expected possibilities.

[nappingpaperclip]

“People who tell you not to vote Biden are psyops trying to steal left votes” type posts are pro-government propoganda.

Last time y’all spread that bullshit around the blogs getting deleted for being “Russian spies” were black leftists.

NOT EVERYONE WHO DISAGREES WITH YOU IS A PSYOP. Get real!!

Not everyone who criticizes Biden or says they won’t be voting for a genocider and that you shouldn’t either wants you to vote for Trump or not vote!! Third party candidates exist!!! Write ins exist!!! If we actually organized instead of y’all pulling the “lesser evil” bs about a GENOCIDAL RACIST RAPIST OLD MAN we might actually see some fuckin progress!!

Did y’all forget Biden is a rapist?????

Btw is the “left” in the room with us? Where is the left? Where is the progress y’all keep claiming Biden is making?

Last time I checked Biden has not let those kids out of cages, has personally approved more huge pipelines that run through Indigenous lands and speed up climate change, has ex-BlackRock leaders (yknow, the top 10 climate change villains company who also funds most American private prisons as well as funding arms manufacturing companies, who spend millions lobbying politicians on environmental regulations, immigration and drug policy) in his cabinet, increased police and military budget, didn’t codify Roe v Wade, in fact he held it hostage for votes, hasn’t codified gay marriage or trans rights, hasn’t legalized marijuana, hasn’t raised the federal minimum wage, oh and also is DOING GENOCIDE in case y’all forgot or wanna tiptoe around the “some bad policies” y’all always talk about

Did y’all forget about his “nothing will fundamentally change” policy?

Y’all heard that and thought “left”?? Babes he’s a right leaning centrist AT BEST.

There are actually left candidates btw! Ones who care about things like Landback and reparations and free healthcare and education and sustainability! The ones y’all are telling people are throwaway votes/votes for Trump!! (Which isn’t even how the electoral college works btw)

So us telling y’all not to vote for a genocider makes us Russian psyop spies but y’all telling us not to vote for leftist third party candidates doesn’t? K.

Vote for who you want, I don’t give a fuck anymore, BUT DONT TELL HIM HE STILL HAS YOUR UNCONDITIONAL SUPPORT WHILE HES COMMITTING GENOCIDE IF YOU ACTUALLY WANT HIM TO STOP

The only way to get a politician to stop doing WAR CRIMES is to tell them you won’t vote for them or give them money or otherwise support them until they stop!

You can fucking lie if you want!!! All we’re asking is for y’all not to publicly announce Genocide Joe still has your unconditional support WHILE HES DOING GENOCIDE

His approval ratings are literally less than Trumps!

He has no one to blame but himself.

If he loses in November, I don’t want to hear y’all bitch and moan and blame black people or disillusioned voters or third party voters or “Russian spies” again like y’all did in 2016, I don’t want to see y’all blame anyone but him, BLAME BIDEN FOR HIS OWN ACTIONS. HE IS A GROWN MAN AND HAS THE MONEY AND POWER TO STOP IT IF HE ACTUALLY WANTED TO.

Y’all keep saying he’s doing his best to stop it, that he’s working behind the scenes, that he’s trying, IF HES TRYING WHY ARE WE STILL SENDING ISRAEL MONEY?

IF HE IS TRYING, WHY DID HE SEND ISRAEL MILLIONS OF DOLLARS IN SMALL PAYMENTS TO AVOID NOTIFYING CONGRESS?

IF HES TRYING WHY HAVE WE NOT SANCTIONED ISRAEL?

IF HES TRYING, WHY HAVE US SOLDIERS BEEN SEEN FIGHTING ALONGSIDE THE IDF?

IF HES TRYING WHY ARE WE SENDING EXPIRED MREs AS AID? EXPIRED FOOD DROPS THAT ARE NOT ENOUGH TO FEED MILLIONS OF STARVING PEOPLE, WITH FAULTY PARACHUTES THAT KILL CHILDREN?

IF HES TRYING, WHY DID WE BUILD A PORT CUTTING THE GAZA STRIP IN HALF, A PORT THAT NETANYAHU SAID WOULD BE USED TO DEPORT PALESTINIANS?

IF HES TRYING WHY DID HE SIGN OFF $14 BILLION FUCKING DOLLARS ON TOP OF THE ANNUAL CONTRACT AND SMALL SECRET PAYMENTS TO GO TOWARDS ISRAELS BOMBS AND GUNS AND FREE HEALTHCARE WHILE IGNORING THE PEOPLE HERE WHO NEED FOOD, HOUSES, AND HEALTHCARE???

DONT MAKE UP RUSSIAN SPIES TO POINT FINGERS AT! IF HE DOESNT WANT TO LOSE HE SHOULDNT DO GENOCIDE

IF GENOCIDE JOE LOSES THE ELECTION FUCKING BLAME HIM FOR DOING A GENOCIDE!!

[covid-safer-hotties]

Coronavirus vaccines, once free, are now pricey for uninsured people - Published Sept 3, 2024

As updated coronavirus vaccines hit U.S. pharmacy shelves, adults without health insurance are discovering the shots are no longer free, instead costing up to $200.

The federal Bridge Access Program covering the cost of coronavirus vaccines for uninsured and underinsured people ran out of funding. Now, Americans with low incomes are weighing whether they can afford to shore up immunity against an unpredictable virus that is no longer a public health emergency but continues to cause long-term complications and hospitalizations and kill tens of thousands of people a year.

The program’s elimination marks the latest tear in a safety net that once ensured people could protect themselves against the coronavirus regardless of their financial situation. Health experts worry that the paltry 22 percent rate of adults staying up-to-date on vaccines will erode further. And they fear that the roughly 25 million people without health insurance in the nation will be especially vulnerable to covid because they tend to be in poorer health and avoid medical care when sick.

Nicole Savant, a 33-year-old part-time paralegal and dog walker, lost her Medicaid benefits last year when her income rose. She wants the latest shot because she knows people who died of covid before the vaccines became available and because she faces a higher risk of severe disease being overweight.

She was floored when she was quoted $201.99 at an appointment to receive the vaccine at a St. Louis-area CVS. She wasn’t sure if she even had that much money in her bank account.

“I have so little money, and I have other needs as well, like monthly medications,” said Savant, who doubts she will get the vaccine if she has to pay out of pocket. “I would hope for the best, which I really don’t want to do.”

At least 34 million doses of last year’s vaccine were administered to adults, according to the Centers for Disease Control and Prevention. Of those, 1.5 million were funded through the Bridge Access Program, which was originally set to end this December, allowing vaccinations ahead of the usual winter wave.

But it expired ahead of schedule because Congress rescinded $6.1 billion in coronavirus emergency spending authority as part of a deal to avert a government shutdown. Congress also declined to fund the Biden administration’s proposal for a Vaccines for Adults program that could provide routine immunizations, including for the coronavirus, for free, similar to an existing Vaccines for Children program.

Private insurers, along with the Medicare and Medicaid government programs, are required to pay for coronavirus vaccines. The Bridge Access Program offered a backup option for people encountering insurance snags.

The CDC said it identified an additional $62 million to buy coronavirus vaccines targeting the latest variants for distribution through state and local health agencies — which local officials say is a sliver of the overall need. CDC spokeswoman Jasmine Reed said the partnership with state and local officials can provide shots to 1 million insured and underinsured Americans.

Raynard Washington, who leads the Mecklenburg County health department in North Carolina, said it’s difficult for financially strapped health agencies to tap their own funds for coronavirus vaccines. Under CDC contracts, health officials spend $78 a dose for the vaccine from the drug company Moderna and pay $100 for the version from Pfizer-BioNTech, compared with $15 to $20 for flu shots.

Washington, who also leads the Big Cities Health Coalition, an organization representing metropolitan health departments, said vaccine manufacturers should charge health departments less to help vaccinate more people without insurance.

“What’s at stake is we are reverting back to a system where a person’s financial ability to be able to pay will determine their ability to be healthy,” Washington said.

Pfizer and Moderna said their vaccines would be available through patient assistance programs that offer free vaccines, but spokespeople did not offer details on the scope and eligibility of those programs. Novavax, whose vaccine was approved by regulators last week, said it does not have a patient assistance program for the upcoming fall season. Moderna and Novavax did not respond to questions about the rate they charge health officials. Pfizer defended its pricing practices.

“Pfizer has priced the vaccine to ensure the price is consistent with the value delivered and with the goal of uninterrupted access for every American,” the company said in a statement provided by spokesman Kit Longley.

Community health centers that often provide low-cost care to uninsured people administered 24 million shots when the federal government provided them, according to the National Association of Community Health Centers. Now, the facilities will have to scale back those programs and rely on local health officials for vaccines, some of whom would have little to share, said Luis Padilla, the association’s chief health officer.

“This country doesn’t provide enough for public health infrastructure and resources,” Padilla said.

The approval of updated coronavirus vaccines on Aug. 22 sent some Americans dashing to get shots before the end of the month. The CDC webpage about the Bridge Access Program, until Friday, said it ended in August without making clear it funded only the previous vaccines, which could no longer be administered after the new shots were authorized.

Adrianna Ruiz, 32, and their girlfriend showed up Wednesday to a CVS appointment in Atlanta hoping to get vaccinated before a Labor Day weekend cross-country road trip to California to help a friend with cancer move their belongings.

Ruiz lost insurance after getting laid off from a nonprofit job in July but believed the vaccine would be free based on the CDC website. But a CVS employee confirmed the program was no longer in effect. Ruiz gets about $300 in weekly unemployment benefits.

“If I want to eat and pay bills, then I can’t afford to pay $200,” Ruiz said.

Instead of getting new shots, Ruiz looked up options to enroll in subsidized insurance plans during the road trip. And the precautions they are embracing on the journey, including taking a PCR test before embarking, wearing N95 respiratory masks at gas stations and packing lunches to eat on picnic blankets in parks, have become more urgent.

Shannon Donnell, a critical care nurse in New York, plans to eat the out-of-pocket costs of an updated coronavirus vaccine. She works on contract without health benefits and said the plans she qualified for through the state’s Affordable Care Act marketplace were too costly with $500 monthly premiums and a $5,000 deductible.

She believes in the urgency of vaccines after watching covid patients die while she worked in Manhattan during the devastating surge in spring 2020 and later cared for unvaccinated patients struggling to breathe in a Texas covid intensive care unit right as the shots arrived. Coronavirus patients no longer flood the intensive care units where she now works, but when they arrive, they are often immunocompromised or unvaccinated.

“It feels like health-care workers are still being left to fend for ourselves in many ways,” Donnell, 48, said. “No one is stepping up to say, ‘Hey, I’ll cover that for you’ before you go into your shift of covering covid patients.”

The Bridge Access Program also extended an opportunity for free coronavirus vaccines to international visitors and undocumented immigrants, who have limited health insurance options.

Vasu, a 56-year-old undocumented and uninsured immigrant in Chicago, hoped to get vaccinated again after hearing about friends getting sick, including one in his 30s whose symptoms lasted for months, and after the outbreak at the Democratic National Convention. A friend offered to pay for her vaccine when Vasu lamented in a Facebook message that the end of the Bridge Access Program left her “screwed.”

“We are talking about a large group of people who are going to lose access or are too nervous about accessing vaccines,” said Vasu, who spoke on the condition she be identified only by a middle name to avoid the scrutiny of immigration authorities. “The government keeps saying it’s your responsibility to be vaccinated. But you are not making it easy.”

The changing landscape for the coronavirus vaccine stands in stark contrast to 2021 and 2022 when free shots were widely distributed. But the urgency of vaccination has subsided as the virus’s toll lessens now that nearly every American has built up immunity from previous infections or shots and hospitals are no longer overwhelmed. People 65 and older, who are at the highest risk of severe illness and death, qualify for free vaccines through Medicare.

Still, health officials recommend young and middle-aged adults receive updated coronavirus vaccines because most Americans have risk factors for complications and because the vaccine reduces the threat of the lingering debilitating symptoms of long covid.

Adriane Casalotti, chief of government and public affairs at the National Association of County and City Health Officials, said the success of the early distribution of coronavirus vaccines “showed us what can be done when you make vaccines accessible and easy to get.”

“But that shifted now,” she added. “We are back to the traditional health-care system we’ve had, and the struggles we’ve had in that health-care system.”

[darkmaga-returns]

Yesterday, I reported about a peer-reviewed study done by high school students under the supervision of US Food and Drug Administration (FDA) scientists at an FDA lab and how they verified that mRNA COVID-19 vaccines are contaminated with DNA from the manufacturing process at levels exceeding the FDA’s own “safety limit”.This is not a “conspiracy theory”. It is not “misinformation”. It is an uncontroversial fact.Of course, the DNA contamination has raised a great controversy about the health risks it poses, but there is no controversy at all that this is a real issue, not made up. It has been repeatedly verified by scientists who have published their findings, including in the medical literature.And yet, I can’t report the fact that it has now been verified by researchers at one of the FDA’s own labs on LinkedIn because LinkedIn has long maintained a policy of censoring truth in service to the criminal organization in Washington and, by extension, in service to the financial interests of the pharmaceutical industry.This, of course, constitutes a violation by LinkedIn of its own User Agreement with me and represents contract fraud.My article about the new study was posted to LinkedIn yesterday and consisted of the link and the factually accurate statement, “Yet another study has verified the problem of DNA contamination in mRNA COVID‑19 vaccines, this time at one of the FDA’s own labs.”

[sorryichasedyourmorning]

IF REPO CHARACTERS WERE CHARGED FOR THEIR CRIMES: FEEL FREE TO ADD IF I MISSED ANYTHING

Nathan: Murder, desecration of a corpse, trafficking and possession of illicit objects, organ theft, medical malpractice, child abuse, abuse, child endangerment, disorderly conduct, disturbance of the peace

Marni: Accessory to murder

Shilo: Disturbance of the peace, disorderly conduct

Mag: Trespassing, disorderly conduct

Rotti: Murder, workplace abuse, child endangerment, hate crimes, illicit contracting

Amber: Possession of illegal drugs, possession of drug paraphernalia, workplace abuse, child endangerment, disorderly conduct, disturbance of the peace, prostitution

Pavi: Murder, desecration of a corpse, workplace abuse, disorderly conduct, harassment

Luigi: Murder, disturbance of the peace, workplace abuse, disorderly conduct, possession of weapons, assault and battery,

Graverobber: Desecration of a corpse, drug trafficking, possession of illegal drugs, possession of drug paraphernalia, disturbance of the peace, vandalism, child endangerment, drug manufacturing and cultivation, theft

[treethymes]

“In his study of [the international coffee] market, scholar Joseph Nevins finds that the big changes occurring between the mid-1970s and the mid-1990s are related to the “longer-term struggle over the distribution of income related to the crop.” In the early part of this period, growers pulled in an average of around 20 cents for every dollar of coffee revenue. They were aided by an agreement called the International Coffee Accord (ICA) of 1962, which acted as a sort of cartel plan, constraining and arranging supply. In the wake of the Cuban Revolution, the Kennedy administration supported the ICA and its concessions to Third World workers as a Cold War tool to head off communist onshoring in the Western Hemisphere. But as the U.S. strategy changed, the country and its free-market Latin American proxies abandoned the ICA in 1989. The results were quick: By the mid-1990s, the grower share was down from 20 to 13 percent. Roasters, traders, and retailers in the drinking countries improved their share from 54 to 78 percent. That big, fast shift was partly thanks to repressed grower wages, partly thanks to repressed domestic service wages in the West, partly thanks to consolidation in the industry, and partly thanks to new high-priced coffee drinks. Starbucks went public in 1992, and if it seemed to be growing like a tech company in the ’90s, that’s because both thrived on the same social changes.

“Worsening conditions for workers in Mexico and in the rest of the Americas pushed people north, rapidly increasing the undocumented immigrant population in the United States. The Bracero program was over, but the jobs still needed doing. Caught in between employers who were hiring migrants and nationalist restrictionists, the Reagan administration legalized a few million undocumented workers while increasing border enforcement. Even though the vast majority of narcotics came into the country via legal ports of entry, conservatives and liberals alike framed border enforcement as a central front in the war on drugs. Increasing the costs of crossing couldn’t stanch the increase of people—they were responding to larger factors: Out-migration from Mexico’s coffee-producing areas increased after the dissolution of the ICA, for example. This tendency intensified after the North American Free Trade Agreement went into effect in 1994, pushing Mexico further toward cheap manufacturing exports and cheap imported American corn.

“The glut of cheap labor and commodities in this period undermined labor protections in the center as well as on the periphery, and the United States lost union jobs at a rapid clip. Reagan undermined the bulwark of government jobs by bringing Boulwarism to the White House. His signature incident occurred in his first year, when he fired more than 11,000 striking air traffic controllers and decertified their union. To the press, the president quoted an air traffic controller who quit the union and reported to work as ordered: “How can I ask my kids to obey the law if I don’t?” Once again, questions of individual criminality put the Reaganites on firm ground. Organized labor took to rearguard action, holding on to its institutions by agreeing to two-tiered contracts that reduced benefits and protections for new or future members. Capital shook off the midcentury labor agreement like a bad habit, reducing its accountability to its own workers the way it previously reduced accountability to the broader communities. The second part didn’t require as many votes.”

Malcolm Harris, Palo Alto

[titleknown]

HELLOWEEN #23: FANTOMISE!

-Fantomise is a Bard-Poet of Hell, with 144 platinum records to his name and 112 bands signed to his service. He may be summoned to grant skill and success at all endeavors musical, sway the hearts of others towards the summoner and to make invisible truths visible.

He appears as a knight with great claws and the head of a metallic bird and speaks in the voice of an angel. Do not challenge him to a duel of musical prowess, you will lose.-

This entry was from one of my sources that wasn't the Last Testament, though it did seem to be trying to pastiche its style and plagarized several of its entries, known as The Black Book of Don Juan.

Fantomise did not appear in the Last Testament because, to put it simply, he is a very new addition to the hosts of Hell. And it appears it is rapidly ascendant, amassing what appears to be by all testaments a hybrid of entertainment complex and a personal army, unusually large and organized compared to the common personal armies of hell. His statuses, for example, have at least doubled since the writing of that entry, dependant on the metrics one utilizes.

Multiple individuals from Trixoin to Gentiflaccio spoke in fear about him, which seems a testament to the power of his rise and thusly the importance of my interview with him. But, it was very difficult to get information about him due to the fact that he would not interview me directly.

I was able to enter his palace, a lavish stylized record studio office, where he sat upon a high platform on a velvet couch being fed grapes by attendants in scant rainiment, but he simply commanded me to "fight" two attendants of his, in a sort of singing-duel.

This was apparently quite common, given that he had an entire backup band behind a curtain for this purpose. I thought I had done quite well, but the fact that I ended up on the streets afterwards said otherwise. So I had to do some digging, both within the archives of Hell and, oddly enough, inside the archives of the world of humans.

This was because, to my surprise, I had found out that he was originally a human, an extremely talented musician by the name of Griffin DePalma in fact, who had lead a cult of personality in our world. Superficially, it appeared to be a rags-to-riches story, building himself up from nothing as a major rock singer and songwriter; even starting his own recording company, attracting marginalized voices from all around to build up a parallel small army there.

He was described as like a "Prince of Rock," and superficially kind and compassionate and beautiful to behold, thought some even then said that there were glimpses of darkness within. That his pursuit towards the acme of rock and desire for adoration was a brittle shell concealing nothing but darkness.

His popularity was his downfall, as the record business in many worlds is a cutthroat hellscape (And yes, from my own experience I would compare it to Hell, but that is its own digression), and so he was indicted on false charges for drug possession and murder and sent into prison, ironically put to work in the fields of manufacturing records, an incident with a record press destroying his beautiful face.

There was a massive protest for his release when he disappeared from the human world, and the data appears to match up to the time when Fantomise appeared in Hell after making an unspecified "deal" under his original name. I say "he" disappeared, but the entire prison, even those protesting in his favor, were gone as well.

There was nothing but a crater left on the date he came. The way the first few floors of his studio resemble the blueprints of the prison I was able to look up, along with some... indications in the walls have ominous implications.

Harkharold is a name that appears in the original contract, so it was likely he was the one who struck what was most likely a deal, an exchange of his service and his audience for power to ascend far beyond as a true Prince of Rock

It would appear at first that the student has yet again surpassed the master, and I presumed at first Harkharold would be consumed with jealousy, but when I asked Harkharold about it, he spoke not with bitterness, but with an odd pride.

Granted, that pride was mostly mocking Amduscias, but it was still a form of pride that seemed dissonant from his frustrated ambition. Well, it may be a cognitive dissonance of political position I suppose, one can be proud of a peer for the same lofty heights you despise in a rival.

Regardless, the willingness to sacrifice those who loved them most is chilling, perhaps the sort of attitude that ascendancy in Hell requires but also the sort of attitude that makes Hell miserable for both demons and souls.

I fear his ambitions may stretch even further beyond Hellish politics than even others, in a way that may impact even you dear reader. I would advise vigilance...

-Xavier X. Xolomon , Monsterologist and Understudy to The Librarian Of Babel

--------------------

Show of hands, who can guess which characters I'm ripping off with this guy, both design and story-wise?

It's probably very obvious to a lot of y'all, but I'm curious whether there's anyone who doesn't know!

Also, I am sad that I cannot compose music, so I cannot show what was certainly a spectacular rock duel between Xavier and Fantomise's two chronies.

Tho I will note, I imagine Xavier being voiced by either John Hodgman or friend of the blog @radicalhelmet, so there's that at least.

As per usual the whole descriptions, designs, ectcetera from this project are free to use as you see fit under a CC-BY 4.0 license so long as I; Thomas F. Johnson, am credited as their creator!

[kadambarimmr123]

Biopharmaceuticals Contract Manufacturing Market size was valued at US$ 3.37 Bn in 2023 and the total revenue is expected to grow at 9.19% through 2024 to 2030, reaching nearly US$ 6.24 Bn.Biopharmaceuticals Contract Manufacturing Market Overview:A contract manufacturing organization (CMO) is a business that, under contract, offers other biopharmaceutical industry organizations specialized services ranging from drug manufacture to drug production. This makes it easier for big biopharmaceutical companies to outsource various aspects of their business, which could improve scalability or boost income for drug research and discovery.

[lets-steal-an-archive]

Since OP didn't provide a link to the press release or the actual solicitation for public comment I copied and pasted it because if you are posting a comment...you should know exactly what you are commenting about?

Solicitation for Public Comment to Understand Lack of Competition and Contracting Practices that May be Contributing to Drug Shortages

I. Background

Multiple agencies within the U.S. government would like to collect additional information about the root causes of and potential solutions to drug shortages. All players within the drug supply chain are intrinsically linked and thus the actions of any market participant can determine whether a drug experiences supply disruptions or shortages. Accordingly, the Federal Trade Commission (FTC), after consulting with the U.S. Department of Health and Human Services (HHS), invites public comment regarding lack of competition and contracting practices by large healthcare group purchasing organizations (GPOs) and drug wholesalers. We are seeking input regarding these entities’ impact on generic pharmaceutical and related markets. This information may inform a better understanding of the root causes of and potential solutions to drug shortages.

II. Solicitation of Public Comments

Accordingly, the FTC and HHS are seeking comments, documents, and data regarding the following topics:

Whether and to what extent manufacturers, GPOs, and drug wholesalers are complying with their legal obligations under Section 3 of the Clayton Act (15 U.S.C. § 14) and the Robinson-Patman Act (15 U.S.C. § 13 et seq.);

Whether and to what extent the available protections for GPOs under the Federal Anti- Kickback Statute (42 U.S.C. § 1320a–7b(b)(3)(C) and 42 C.F.R. § 1001.952(j)) affect lack of competition, contracting practices by GPOs, and drug shortages;

Whether and to what extent lack of competition among GPOs and drug wholesalers impacts patients, hospitals, healthcare providers, pharmacies, generic manufacturers, and other suppliers;

Whether and to what extent lack of competition among GPOs and drug wholesalers impacts smaller healthcare providers and rural hospitals;

Whether and to what extent lack of competition among GPOs and drug wholesalers disincentivizes suppliers from competing in generic drug markets;

The impact of GPO and drug wholesalers’ contracting practices, including re-bidding provisions, most-favored nation pricing and similar clauses, as well as any other relevant contract terms or pricing or compensation models on generic manufacturers and other suppliers;

The impact of GPO compensation models, which may rely on rebates, chargebacks, and administrative fees from manufacturers in exchange for favorable treatment, on generic manufacturers and other suppliers;

GPO and drug wholesalers’ practices with respect to generic manufacturers and other suppliers, including the usual process of negotiations, the use of exclusive or near-exclusive contracts, the use and terms of failure-to-supply clauses (duration, compensation, and exclusion criteria), parties’ criteria for selecting suppliers, and all parties’ sources of compensation;

GPO contracting practices with respect to hospitals and other healthcare providers, including the normal process for negotiations, the use of market-share or volume-based rebates, the use of manufacturer-quality information, the use of and terms of failure-to-supply clauses, and the terms, source, and disclosure of GPO compensation;

Drug wholesalers’ contracting practices with respect to pharmacies, hospitals, and other healthcare providers, including the normal process for negotiations, the use of market-share or volume-based rebates, the use of manufacturer-quality information, and the terms, source, and disclosure of drug wholesalers’ compensation;

Instances of hospitals, pharmacies, or healthcare providers being contractually prohibited or disincentivized from purchasing either lower-cost or higher-quality products as the result of GPO or wholesaler contractual policies or restrictions;

Evidence of or instances in which the market power of GPOs or drug wholesalers in upstream or downstream markets directly contributed to a reduction in the number of suppliers, less reliable supply chains, or drug shortages;

Information regarding how GPOs and drug wholesalers’ contracting practices differ based on the type of product being purchased (e.g., an injectable);

Examples of approaches that have been used to successfully alleviate the adverse effects of actual drug shortages or to avoid potential shortages;

Examples of policies, programs, methods, and innovations that may help keep drug costs low while also incentivizing pricing that would allow for continued investment in manufacturing-quality systems, which, in turn, can help prevent or mitigate drug shortages;

What changes could be made in GPO contracting practices to incentivize manufacturers to maintain a steady and reliable supply of high-quality products, while also allowing these products to be purchased by healthcare providers at an affordable price;

Any other similar issues or concerns regarding GPOs or drug wholesalers that may contribute to drug shortages as the public deems relevant.

We encourage the public to comment by submitting written comments, documents, and data addressing these topics. Comments will be posted on regulations.gov website. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential or sensitive information that you or a third party may not wish to be posted.

TL;DR This is more about chemotherapy and antibiotics than stimulants. Stimulants are in short supply (again) because of the DEA.

The DEA authorizes a certain amount of the API in Adderall - mixed amphetamine salts - to be released to drugmakers each year based on what the agency considers to be the country's legitimate medical need.

Increasingly that estimate is coming into conflict with what companies themselves say they need to meet demand for the drug, which is reaching all-time highs. In 2010, more than 18 million prescriptions were written for Adderall, up 13.4 percent from 2009, according to IMS Health, which tracks prescription data.

Concerns are now rising among patient groups and doctors that the shortages seen in 2011 will continue into this year. Many orders remain unfilled, manufacturers say, and it may take several months before ingredient authorized under the new 2012 quota can be turned into new product.

Source: Shortage of ADHD drug Adderall seen persisting (1 Jan 2012)

In recent months, patients have reported problems filling nearly every type of ADHD medication. What’s stranger is that no one seems to know why. Is it some kind of supply chain issue? A pandemic-era surge in demand? A government crackdown?

Official explanations have offered little clarity. The FDA’s announcement mentioned “intermittent manufacturing delays” at Teva, the producer of the branded version of Adderall, but few other details. The American Society of Health Pharmacists reports shortages of multiple ADHD drugs but says manufacturers have given no explanation.

Meanwhile, the Drug Enforcement Administration (DEA), which controls the supply of the drugs, announced last month that it would not increase manufacturing quotas for 2023, despite the shortage – again, without providing a reason. One congresswoman, Abigail Spanberger, wrote to the DEA and FDA to demand an explanation last December, but Spanberger’s staff told the Guardian she had yet to receive a response.

Source: ‘The worst it’s ever been’: mysterious US Adderall shortage puts ADHD patients at risk (30 Jan 2023)

Drugmakers and the Drug Enforcement Administration, which regulates controlled substances, are pointing fingers at one another for the problem, said Erin Fox, senior pharmacy director at the University of Utah Health. 

Makers of ADHD drugs say they don’t have enough ingredients to make the drugs and need permission from the DEA to make more. The DEA is insisting that drugmakers have not met their quota for production and could make more of the drugs if they wanted. Adderall is a controlled substance regulated by DEA, which sets limits on how much of the active ingredient drugmakers are allowed to produce in a given time frame. Drugmakers must get approval from the DEA before they go over their quotas.

Source: ‘I’m fed up’: Frustrations grow as ADHD drug shortage continues (6 Feb 2024)

There’s been a national shortage of ADHD medication for more than a year and a half. According to the government and industry experts, there are multiple overlapping causes: manufacturing problems, labor issues, supply-chain failures, and a huge rise in demand during the pandemic. But Ascent claims there’s another factor exacerbating the shortage, one that’s completely sui generis: the fact that it’s been shut down by the Drug Enforcement Administration.

The agency has accused Ascent of shabby recordkeeping that might have allowed millions of pills to go unaccounted for. Ascent makes painkillers in addition to stimulants, and, amid the ongoing opioid epidemic, the DEA has been under pressure to show it is aggressively policing the industry. (The agency did not respond to requests for comment.) Ascent has said that its paperwork is in order and has sued the Department of Justice to get its assembly lines working again.

Source: The Empty Adderall Factory (19 Feb 2024)

FEDERAL INQUIRY INTO ADHD MEDICATION SHORTAGE ANNNOUNCED

IF YOU HAVE STRUGGLED TO GET YOUR ADHD MEDICATION, YOU HAVE 60 DAYS TO TELL THE FTC YOUR STORY FOR CONSIDERATION IN THIS INQUIRY AT THE LINK BELOW! The FTC must read all responses. So tell them about having to call multiple pharmacies, being unable to get generics, your struggles with insurance coverage, everything!

[pinnacleblogs]

How CDMO Companies Are Transforming Oncology Drug Manufacturing in India

India has emerged as a world power with respect to pharmaceutical manufacturing with particular reference to oncology. The indispensable and pivotal role of CDMO companies towards revolutionizing the manufacturing of oncology drugs in India is evident and undeniable. With the end-to-end solutions that such companies provide, the entire production process becomes streamlined, hence, lessening cost-effective yet ensuring a world-class, quality end product for all patients who need it. Partnering with oncology drugs manufacturers and with the skilled expertise of pharmaceutical contract manufacturers, India is indeed on its way toward ensuring affordable, high-quality global cancer therapy supply.

1. Enhancing Production Capacity and Scalability

One of the major challenges facing oncology drug manufacturing is that it is an area of high production and yet maintains a great standard. India CDMO provides very flexible and scalable manufacturing solutions that allow oncology drugs manufacturers, thus meeting clinic and commercial production requirements. From small batch production for clinical trials to large-scale manufacturing, CDMOs provide the infrastructure and expertise required to manage varying production volumes. Ensuring that oncology drugs will be sufficiently present at disposal all over the world, especially since the increasing demand for cancer treatment has captured people's attention.

2. Cost-Effectiveness and Affordability

The global pharmaceutical supply chain relies heavily on India's cost-effective manufacturing solutions. Cost-effective Pharma contract manufacturing in India provides oncology companies an edge over competitors by helping to cut down on manufacturing costs. In fact, such cost-efficiency becomes important in the context of oncology, as research, development, and production costs are often high, which consequently keeps driving up the costs of treatment. Offsetting in this way under the purview of pharmaceutical contract manufacturers in India is therefore a way through which oncology companies can save on production and further cut costs, bringing life-saving therapy closer to patients.

3. Access to Expertise and Cutting-Edge Technology

Oncology drug manufactures call for pertinent proficiency and advanced technology, especially for complex biologics and other novel cancer therapies. The facilities of these contract development and manufacturing organizations in India are first-rate and have considerable experience managing the complexities of oncology drug production. In collaboration with oncology drugs manufacturers, these companies are dedicated to ensuring that each drug they produce meets the rigorous requirements of global regulatory authorities. Thus, with appropriate technical expertise and state-of-the-art technology, pharma contract manufacturing in India becomes the platform upon which advanced oncology treatments could be developed safely and efficiently.

4. Global Regulatory Compliance

Highly stringent regulations, including very strict guidelines, govern drug development, its manufacturing, and the distribution. They also go to a great extent to involve the contractual manufacturing organizations in India in being at the forefront of ensuring international capabilities, like Good Manufacturing Technologies. The Indian pharmaceutical contract manufacturers are quite well versed with the entire compulsive regulations emerged by the U.S. FDA and European Medicines Agency (EMA), among other chapters. This huge European appraises all processes and mostly applies to the top oncology pharmaceutical companies that want to penetrate the global market with the purest products at the highest benchmark possible in quality, safety, and effectiveness.

5. Accelerating Time-to-Market

Not only is it one of the competitive factors in the oncology sector, but also the nature and timing taken to get a new treatment into the market is critical for the oncology sector. Indian CDMO companies therefore bring all these streamlined solutions that hasten up the development and production processes, enabling oncology drug products to get into the marketplace much faster. Indian pharmaceutical contract manufacturers also carry excellent core competences in formulation development, clinical trial support, and large-scale manufacturing. This shortens up development time for oncology drugs, thereby allowing companies to launch novel cancer treatments quicker, thereby ramping up access to some life-saving treatments by patients.

6. Innovation and Research Support

The research and development efforts towards the make of oncology drugs are presently being sustained in India's CDMO companies. These would include partnerships with the top oncology pharmaceutical companies in offering the greatest insights and services ever in drug formulation, packaging, and production possible. It is this synergy that pushes the perimeters of cancer treatment to innovate and route new, promising therapies to reach the market much more quickly.

Conclusion

Thus, it can be said that CDMO companies in India are paving the way to cost-effective yet scalable and high-end manufacturing solutions for oncology. Through their expertise with advanced facilities, pharmaceutical contract manufacturers in India will play a pivotal role in meeting the unmet demands of the market in the ever-challenging cancer treatments. The continuing use of Indian capabilities by top-oncology pharmaceutical companies to procure their products would therefore ensure the critical contribution of India's oncology drug supply chain toward making cancer treatments accessible and affordable for patients across the globe.

[skillbesolution]

Certification in Pharmacovigilance: A Pathway to Excellence in Drug Safety

Pharmacovigilance is a critical field within the pharmaceutical industry, focused on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. As the healthcare sector continues to evolve, ensuring drug safety has become more paramount than ever. This has led to a growing demand for trained professionals who can ensure that medications are safe and effective for public use. One of the most effective ways to enhance career prospects and expertise in this field is by obtaining a Certification in Pharmacovigilance.

What is Pharmacovigilance Certification?

A Certification on Pharmacovigilence is a specialized qualification that provides professionals with the knowledge and skills necessary to identify and manage the risks associated with pharmaceutical products. The certification process typically involves formal education in drug safety, regulatory standards, clinical trials, and risk management strategies. A candidate pursuing this certification is trained to collect and analyze data related to adverse drug reactions (ADRs), which are crucial for assessing the safety profiles of medications post-market.

Why Pursue Pharmacovigilance Certification?

1. Career Opportunities and Growth: The global pharmaceutical industry is growing rapidly, and the need for skilled pharmacovigilance professionals is at an all-time high. With a certification in pharmacovigilance, individuals can enhance their job prospects and qualify for roles such as drug safety officers, pharmacovigilance scientists, or clinical research associates.

2. Expertise in Drug Safety: A pharmacovigilance certification offers in-depth knowledge of regulatory guidelines and safety reporting processes. Professionals are trained to manage risk assessment, develop safety protocols, and ensure compliance with international standards such as ICH E2E, FDA, and EMA guidelines.

3. Improved Salary Potential: As with any specialized field, pharmacovigilance professionals often command competitive salaries. Certified professionals are viewed as experts and are more likely to secure higher-paying positions, especially in pharmaceutical companies, regulatory agencies, and contract research organizations.

4. Global Recognition: Pharmacovigilance certification programs are recognized globally, making it easier for certified professionals to work internationally in various pharmaceutical or clinical research organizations.

Certified Pharma Engineering Professional

In parallel with pharmacovigilance, the certification of professionals in pharmaceutical engineering is gaining significant importance. Pharmaceutical engineering professionals play a vital role in ensuring the safe and efficient production of pharmaceutical products. A Certified Pharma Engineering Professional (CPEP) certification is an advanced credential that validates an individual's expertise in the manufacturing, quality control, and regulatory aspects of pharmaceutical production.

The CPEP certification is designed for professionals in pharmaceutical manufacturing, design, and engineering roles. This certification equips them with the knowledge of good manufacturing practices (GMP), process optimization, and compliance with global regulatory requirements. For those looking to advance their careers in pharmaceutical production or related fields, becoming a CPEP can provide numerous career advancement opportunities.

Conclusion

Both pharmacovigilance and pharmaceutical engineering certifications are valuable in the rapidly evolving healthcare and pharmaceutical sectors. These certifications not only offer a deeper understanding of drug safety and manufacturing but also open doors to rewarding career paths. As the demand for highly skilled professionals continues to grow, certifications in these fields serve as a gateway to personal growth and industry recognition, benefiting both individuals and the broader pharmaceutical industry.