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.
Sun Pharma has been stung by a decade-old pay-for-delay lawsuit, one of a of a host of issues that contributed to a 74% profit slide.
German regulators have pulled the manufacturing certificate for Dr. Reddy’s formulation plant in India.
A Canadian company that sells topical vitamin C skin treatments is in trouble with the FDA, which says it needs is a dose of cGMP practices.