The FDA has banned the OTC products of a Canadian drugmaker after finding it was using ingredients from a supplier already on its import alert list.

Manufacturing issues at legacy Hospira plants have taken a toll on Pfizer’s earnings and created serious problems for some of its clients.

India-based API maker Vital Laboratories was slapped with a warning letter from the FDA over manufacturing and records issues at its Plant II located in Vapi,…

A report by the European Medicines Agency lays out the reason why German regulators pulled the GMP certificate from a Dr. Reddy's plant in India.

Chinese drugmaker Asymchem Laboratories’ API plant in Dunhua successfully passed an inspection by Australian drug regulators for a second consecutive time, the…

Sun Pharmaceuticals said the FDA has cleared its manufacturing facility at Dadra that had received a warning letter from the agency earlier this year.

The FDA has issued Biocon and partner Mylan a complete response letter for their biosimilar of chemotherapy drug Neulasta tied to manufacturing.

Novo has filed a citizen petition saying Victoza’s manufacturing is so complex that equivalence of generics can't be certain without clinical trials.

Regulatory