Topic: FDA warning letter
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.
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.