The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility
The product combines proven efficacy of Doxylamine succinate 20 mg and Pyridoxine hydrochloride 20 mg in an Extended Release formulation
ANVISA issues CGMP to Concord Biotech’s Unit I
Sadhana Nitro Chem's plant is the second plant in the world to manufacture pAP from Nitrobenzene
Cipla completes transfer of Generics Business Undertaking
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