Topic: FDA warning letter
Samsung won FDA nod for a Remicade biosim, Otsuka expanded anemia deal with Akebia, analysts are cautiously optimistic about China's foreign drug proposal.
The FDA, which banned APIs coming from a Divi’s plant in India, has followed that with a warning letter that savages the facility for a lack of data integrity.
For nearly two years Teva struggled with impurity issues for an API manufactured at a plant in China.
Swiss CDMO Lonza, which has run into FDA concerns about its FDA operations before, has had its cell therapy facility in the U.S. slapped with a warning letter.
Sun Pharma has had another setback in its manufacturing for the U.S. market with the FDA laying out nearly a dozen observations for a solid dose formulation plant in Dadra.
The FDA served a Mylan plant with a warning letter, Takeda inked a microbiome GI deal with NuBiyota and China works on new trial data fabrication policies.
The FDA has nailed another Teva manufacturing facility with a warning letter, this time for an API facility in China.
India’s Indico Remedies has had a sterile injectables plant blasted in an FDA warning letter for its laissez-faire approach to dealing with consumer complaints.
Another Mylan plant in India has been issued a warning letter.
Gilead is planning its first foreign manufacturing facility, Takeda will develop an IBD drug from Finch while cutting 180 workers at Ariad after the buyout.