Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against ...

Ottawa, Nov. 21, 2025 (GLOBE NEWSWIRE) -- The global GMP drug substance market size was valued at USD 2.55 billion in 2024 and is predicted to hit around USD 4.64 billion by 2034, rising at a 6.14% ...

Dr Reddy's Laboratories receives US FDA Form 483 with five observations at Srikakulam facility; company to address issues ...

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good ...

Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...

The US Food and Drug Administration (FDA) last month warned Hialeah, FL-based drugmaker Allay Pharmaceuticals over good manufacturing practice (GMP) issues identified during a rare on-site inspection ...

The "cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Nov 13, 2025)" training has been added to ResearchAndMarkets.com's offering. cGMP or current good manufacturing practices are ...

Core One Labs (OTCQB:CLABF) acquired GMP Drug in a deal worth C$2.8M common stock plus bonus shares to pave the way to become a full-cycle psychedelics supply chain solution provider. Privately held ...