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FDA Clears Hyderabad Facility for Granules Life Sciences
12 Dec
Summary
- Granules Life Sciences' Hyderabad facility received FDA Establishment Inspection Report.
- Inspection confirmed compliance with FDA quality standards and regulatory requirements.
- Facility manufactures Pharmaceutical Intermediate and finished dosages.
Granules Life Sciences Private Limited, a wholly-owned subsidiary of Granules India Limited, has successfully obtained an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). This report pertains to the inspection conducted at their Hyderabad facility between July 28 and August 1, 2025. The FDA's clearance signifies that the facility meets the stringent quality standards and regulatory requirements mandated by the agency.
The Hyderabad-based facility plays a vital role in the manufacturing processes for Granules Life Sciences. Specifically, it is involved in the production of Pharmaceutical Intermediate (PFI) and finished dosage forms. This successful inspection bolsters confidence in the company's manufacturing operations and its ability to comply with international pharmaceutical regulations.
This positive development comes at a time when Granules India has shown robust financial performance. In the September quarter, the company reported a net profit of ₹131 crore, with revenue increasing by 34.2% to ₹1,297 crore and EBITDA growing by 37% to ₹278 crore, indicating strong operational and financial health.
