Topic: FDA warning letter
The FDA released a warning letter sent to Chinese API maker Qinhuangdao Zizhu Pharmaceutical in April that outlined data integrity problems.
Lingering regulatory problems at the Sun Pharma plant Halol, India, have contributed to a $14.1 billion slide in founder Dilip Shanghvi’s net worth.
Lonza, which is dealing with FDA concerns about its cell manufacturing facility in the U.S., has acquired a gene and cell CMO in Europe.
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.