Date: August 14, 2026
Regulatory Filing
This disclosure, made under Regulation 30 of the SEBI (LODR) Regulations, 2015, informs about a recent US Food & Drug Administration (USFDA) inspection.
Operational / Regulatory Disclosures
- The United States Food & Drug Administration (USFDA) completed a Good Manufacturing Practice (GMP) inspection at the company's formulations manufacturing facility, designated FTO-3, located in Bachupally, Hyderabad.
- The inspection period was from August 6, 2026, to August 14, 2026.
- The outcome of the inspection was the issuance of a Form 483.
- The Form 483 contains four observations.
- The company states it will address all observations within the stipulated timeline provided by the regulator.
Other Disclosures
- The disclosure is signed by K Randhir Singh, Company Secretary, Compliance Officer & Head-CSR.
- The communication is addressed to the National Stock Exchange of India Ltd., BSE Limited, New York Stock Exchange Inc., and NSE IFSC Ltd.
No material disclosures under the following sections: KMP / Board / Auditor Changes, Dividend Declaration, Board Meeting Outcomes, Financial Results, Auditor’s Report, Disinvestment / Strategic Actions, Media Release / Investor Communication.