Strides Pharma Science Limited has submitted a regulatory disclosure under Regulation 30 of the SEBI Listing Regulations regarding a recent US Food and Drug Administration (USFDA) inspection.
The company reports that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at its formulations manufacturing facility located in Alathur, Chennai. The inspection period spanned from September 2, 2026, to September 11, 2026.
At the conclusion of the inspection, the USFDA issued a Form 483 containing three observations. The company has committed to responding to these observations within the stipulated timeframe set by the regulatory agency.
The disclosure states that the company will keep the stock exchanges informed of any further updates regarding this matter. The financial impact of these observations has not been quantified in the disclosure.