SMS Pharmaceuticals Gets USFDA Clearance for Hyderabad Lab With NAI Status

29 Aug 2025 , 10:52 AM

SMS Pharmaceuticals Ltd announced it had received an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) status for its Central Laboratory Analytical Services in Hyderabad.

The USFDA inspected the Hyderabad facility between June 23 and June 25 and issued an Establishment Inspection Report (EIR) with a No Action Indicated (NAI) status, confirming closure of the audit. Importantly, the inspection ended with zero observations Form 483 observations.

Strong regulatory news comes alongside a solid earnings print. For the June quarter, SMS Pharma reported a 24.3% year-on-year jump in net profit to ₹20.49 crore, compared with ₹16.48 crore a year earlier. Revenue grew 19.2% to ₹196.05 crore.

The company also completed its backward integration project, which Executive Director P. Vamsi Krishna said will strengthen supply chains and improve cost efficiencies. “With full backward integration now in place for our key APIs, we expect to see meaningful margin expansion in the coming quarters,” he said.

SMS Pharma manufactures active pharmaceutical ingredients (APIs) and intermediates. It runs an R&D centre in Gagillapur, Hyderabad, and production units at Bachupally (Hyderabad) and Kandivalasa (Vizianagaram, Andhra Pradesh).

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