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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
Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues. Read More
The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process. Read More