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.
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.
Novo has filed a citizen petition saying Victoza’s manufacturing is so complex that equivalence of generics can't be certain without clinical trials.
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
The FDA is concerned that disruption of drug manufacturing in Puerto Rico could lead to critical shortages of some medicines.
AmerisourceBergen has pled guilty and agreed to pay $260 million to settle a federal case over its sales of cancer meds from an unregistered facility.
The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.