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Spanish regulators are recommending that EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More
Valeant Pharmaceuticals’ application for a latanoprostene bunod eye solution was rejected by the FDA amid concerns about conditions at the company’s manufacturing facilities. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More