Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a Form 483 to Strides Pharma Sciences Ltd., Bangalore facility (FEI 3004554612)
Aurobindo’s Eugia Pharma Specialities Limited (FEI 3011960448), located at Shameerpet, India, has been classified OAI
The U.S. FDA has issued a Warning Letter to Simtra BioPharma Solutions following cGMP deviations
The USFDA has issued a Warning Letter to the Indian drug manufacturing facility of Patcos
Indian pharma major Zydus Lifesciences has received approval from China’s National Medical Products Administration (NMPA)
The USFDA has Approved the NDA for ADQUEY (Difamilast 1%) ointment for the treatment of
The Government of India has published a draft notification proposing an amendment to the Drugs
The USFDA issued a Warning Letter to API manufacturer Chemspec Chemicals (Mumbai) in December 2025,
The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated
An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor
