SMS Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for its API manufacturing facility at Kazipally, Telangana. The inspection concluded with a “Voluntary Action Indicated” (VAI) classification.

This EIR, received on July 15, 2025, confirms the company’s adherence to global quality norms and clears the way for continued exports to the US and other regulated markets. It follows an earlier inspection update shared by the company in May this year.

In the exchange filings, SMS Lifesciences shared, “We are pleased to inform that the Company has received Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration for our API manufacturing facility (Unit 1) located at Kazipally, Telangana, on July 15, 2025 at 09.37 pm.”

The development strengthens SMS Lifesciences’ position as a reliable global API supplier.