J.B. Chemicals’ Gujarat API facility clears USFDA inspection with no observations

J.B. Chemicals & Pharmaceuticals Ltd. announced that its Active Pharmaceutical Ingredient (API) manufacturing facility, D9, located in Panoli, Gujarat, underwent an inspection by the United States Food and Drug Administration (USFDA) from March 10, 2025, to March 13, 2025. The inspection successfully concluded with “No Observations,” and no Form 483 was issued, indicating full compliance with USFDA standards.

The company expressed its satisfaction with the outcome, reaffirming its dedication to upholding high-quality standards in pharmaceutical manufacturing. J.B. Chemicals highlighted that it has embedded a strong quality culture within its operations, continually investing in advanced systems, robust processes, and employee training to ensure regulatory compliance across all global markets. The successful USFDA inspection is expected to further strengthen the company’s position in the international pharmaceutical sector.

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The announcement came after the stock markets had closed. Market analysts believe that the successful clearance from USFDA could act as a positive trigger for the stock in the upcoming trading sessions.