Granules Cemented Business Operations: Finished US FDA Inspection with 6 Observations

Granules India Limited, a leading global pharmaceutical company, announced the successful completion of a US Food and Drug Administration (USFDA) inspection at its Gagillapur facility in Hyderabad, Telangana. The comprehensive inspection, conducted from August 26 to September 6, 2024, assessed the facility’s adherence to Current Good Manufacturing Practice (cGMP) standards and Pre-Approval Inspection (PAI) requirements.

While the inspection concluded with six observations, Granules India remains committed to addressing these promptly and comprehensively. The company will submit a detailed response to the US FDA within the stipulated time frame, demonstrating its dedication to maintaining the highest quality standards.

The Gagillapur facility plays a pivotal role in Granules India’s global operations, serving as a key manufacturing hub for a wide range of pharmaceutical products. The facility’s successful completion of the USFDA inspection reinforces its commitment to delivering high-quality medicines that meet stringent regulatory requirements and exceed customer expectations. Granules India remains steadfast in its pursuit of excellence, striving to improve its manufacturing processes and contribute to better global health outcomes.

In August, the company received approval from the US FDA for the Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to Pragma Pharmaceuticals, LLC’s reference-listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg.

About Granules India Limited

Incorporated in 1991, Granules India Limited is a vertically integrated, fast-growing Indian pharmaceutical company headquartered in Hyderabad. It has best-in-class facilities and a commitment to operational excellence, quality, and customer service. 

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