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Key Considerations for Generic Drug Stability Testing

Drug Patent Watch

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? For generic drug manufacturers, stability testing is a critical step in the development process.

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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm. Most of the US insulin market is controlled by three pharma companies: Sanofi, Eli Lilly, and Novo Nordisk.

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In the News: September 2021 Regulatory and Development Updates

Camargo

The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The sponsors of the accepted proposals will submit a full package consisting of required toxicology and quality data, as outlined in the Federal Register. Container-closure changes.

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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

Marketing 173
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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

Marketing 130
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Even Drugs Manufactured in America are not “Made in the USA”

Pharmacy Checkers

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. But what does this all say about where our drugs really come from?

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Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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