Topic: FDA warning letter
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.
The FDA has warned the maker of an OTC oral rinse product to stop manufacturing it on the same equipment it uses to produce a car polish.
A whistleblower suit against Gilead is revived, Biocon and Mylan's Herceptin biosim is delayed, and AZ is upping production to meet demands in China.
The FDA has issued a warning letter to India's Vista Pharmaceuticals after it found it using corroded equipment.
An FDA warning letter has been issued to a CMO that made belladonna-treated teething products that the agency warned may cause seizures in infants.
China’s FDA joined ICH, Takeda completed new solid dosage plant, the FDA bans imports of Ipca drugs.
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.