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Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
Sponsors with pending ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
Two more compounding pharmacies are in the FDA’s crosshairs, with one faulted for failing to maintain proper sterility while the other was accused of compounding without valid prescriptions. Read More
French authorities want to ban marketing applications from an Indian manufacturing site after an inspection turned up a whopping 58 GMP violations. Read More
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
A newly released Form 483 faults Indian drugmaker Glenmark Pharmaceuticals for neglecting multiple controls in its procedures at its Pithampur facility. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More