AmerisourceBergen's costs to resolve federal litigation tied to syringe sold from an unregistered facility have more than doubled to $575 million.

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.

Biocon has seen its earnings hit by FDA and EU regulatory issues at its Indian plant that makes the biosimilars it and partner Mylan have developed.

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,…

Still struggling to turn its manufacturing around, Dr. Reddy's is recalling 569,000 store-brand famotidine tablets in the U.S.

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.