Topic: FDA warning letter
After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document disaster at its API plant in Ahmedabad. Now the agency has taken the step of banning all of the company’s products produced at the facility.
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.
The worst is over for a CordenPharma sterile manufacturing plant in Italy that was slapped last year with an FDA warning letter.
Zai Lab filed for a $115 million Nasdaq IPO, Takeda formed an R&D deal with Stanford, Fosun and Shanghai Pharma aim to buy a stake in Arbor, and more.
The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its plant in Guangdong, China.
The FDA bit into homeopathic pharmaceutical manufacturer Homeolab USA over belladonna-treated teething products that CVS took off the shelf last year.
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.
GSK will close its Shanghai neuroscience R&D hub, Pfizer and Astellas stopped Xtandi's breast cancer study and more.
Dr. Reddy's CEO GV Prasad says the generic drugmaker’s top priority is to do what is needed to get its manufacturing up to FDA expectations.
The FDA has slapped an Italian sterile manufacturer with a warning letter pointing to the contamination hazards tied to its highly manual processes.