Topic: FDA warning letter
The FDA has brought its regulatory hammer down on a B. Braun plant in California that makes parenteral drugs, saying managers let problems go on for more than two years.
Earlier this month, the FDA banned all products being shipped to the U.S. by a Chinese API maker, and a new warning letter explains why. It appears the ingredient maker had no clue, or didn't care, about how to meet basic FDA GMP expectations.
The manufacturing problems at Sun Pharma’s key Halol, India, plant have again stymied approval of a new drug from Sun's novel drug development group, SPARC.
India’s Dr. Reddy’s Laboratories, which has been whiplashed repeatedly by FDA actions against its plants, saw its sales in the U.S. fall markedly in the last fiscal year.
Just eight months after receiving an FDA warning letter for a U.S. plant bought from Sun Pharma, Frontida BioPharm says the plant has been given an all-clear.
The FDA has warned Vikshara Trading & Investments for its repeated efforts to keep inspectors from getting a look into its filthy plant.
India’s Wockhardt saw its losses widen last year as its burgeoning regulatory issues with the FDA continue to chainsaw away at its finances.
Takeda got FDA approval for Ariad-developed Alunbrig, WuXi NextCODE secured a $75 million Series B, and the FDA cited the third Dr. Reddy's plant this year.
A recent report says that FDA inspections of Indian drugmakers tripled between 2010 and 2015, and that trend continues this year, with the latest to feel the heat being Sal Pharma.