Granules India Subsidiary's FDA Inspection Concludes with 5 Procedural Observations

Granules India Limited announced that its wholly-owned subsidiary, Granules Life Sciences Private Limited (GLS), located in Hyderabad, has successfully completed an inspection by the U.S. Food and Dru...

Granules India Limited announced that its wholly-owned subsidiary, Granules Life Sciences Private Limited (GLS), located in Hyderabad, has successfully completed an inspection by the U.S. Food and Drug Administration (FDA). The inspection, which focused on Good Manufacturing Practices (GMP) and Prior Approval, took place from December 15th to December 19th, 2025. The inspection concluded with a total of five observations, all related to procedural requirements. Importantly, none of the observations raised by the FDA pertain to data integrity or product safety. Granules India has affirmed its commitment to promptly addressing these observations and will submit its formal response to the USFDA within the designated timeframe. Granules Life Sciences Private Limited is involved in the manufacturing of PFI (Pharmaceutical Intermediates) and Finished Dosages.

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Why is Granules India Limited in the news today?

Granules India Limited (GRANULES) is in the news due to the fda inspection concluded with procedural observations, which are standard. while not directly impacting data integrity or safety, the observations require a response, making the outcome neutral.

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Granules India Subsidiary's FDA Inspection Concludes with 5 Procedural Observations

December 19, 2025, 02:13 PM

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Granules India Limited announced that its wholly-owned subsidiary, Granules Life Sciences Private Limited (GLS), located in Hyderabad, has successfully completed an inspection by the U.S. Food and Drug Administration (FDA).

The inspection, which focused on Good Manufacturing Practices (GMP) and Prior Approval, took place from December 15th to December 19th, 2025. The inspection concluded with a total of five observations, all related to procedural requirements.

Importantly, none of the observations raised by the FDA pertain to data integrity or product safety. Granules India has affirmed its commitment to promptly addressing these observations and will submit its formal response to the USFDA within the designated timeframe. Granules Life Sciences Private Limited is involved in the manufacturing of PFI (Pharmaceutical Intermediates) and Finished Dosages.

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