A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.
Approval of Acorda's candidate for an inhaled drug for Parkinson's disease is in jeopardy because of FDA questions about Acorda's manufacturing.
The worst is over for a CordenPharma sterile manufacturing plant in Italy that was slapped last year with an FDA warning letter.
The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.…
Valeant says the situation is looking up at that Bausch + Lomb plant that has twice been responsible for Valeant receiving a CRL for a new eye drug.
The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its plant in Guangdong, China.
Biocon, which pulled its EU application for a Herceptin biosimilar because of manufacturing issues, expects to resubmit to authorities next quarter.
The FDA bit into homeopathic pharmaceutical manufacturer Homeolab USA over belladonna-treated teething products that CVS took off the shelf last year.
The FDA has warned of potential contamination of a number of brands of drugs and dietary supplements manufactured by PharmaTech.
German regulators have pulled the manufacturing certificate from a Dr. Reddy’s formulation plant located in Bachupally, India, following an inspection.