Synopsis: SMS Lifesciences received a USFDA EIR with Voluntary Action Indicated (VAI) status for its Telangana API facility, reaffirming regulatory compliance and supporting continued access to US and global markets.
During Wednesday’s trading session, shares of a global player in pharmaceutical APIs/Intermediates manufacturing hit a 20 percent upper circuit on the stock exchanges, after receiving Establishment Inspection Report (EIR) from USFDA for its Telangana facility.
With a market cap of Rs. 393 crores, shares of SMS Lifesciences India Limited closed in the green at Rs. 1,299.15 on BSE, up by nearly 13.6 percent, as against its previous closing price of Rs. 1,143.8. The stock has delivered positive returns of over 55 percent in one year, and has gained by nearly 10 percent in the last one month.
What’s the News
As per the latest regulatory filings, SMS Lifesciences India Limited has announced receiving the Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (USFDA) for its API manufacturing facility (Unit 1) at Kazipally, Telangana.
The receipt of EIR reaffirms the company’s commitment to maintaining global quality standards and enables access to the regulated US market and other highly regulated global markets. The USFDA inspection at the Kazipally facility was conducted between 5th May and 9th May 2025, and concluded with a single observation.
Financials
SMS Lifesciences reported a marginal decline in revenue from operations, experiencing a year-on-year fall of nearly 1.1 percent, from Rs. 90 crores in Q4 FY24 to Rs. 89 crores in Q4 FY25. Similarly, the company’s net profit decreased during the same period from Rs. 6.5 crores to Rs. 3.5 crores, representing a decline of nearly 46 percent YoY.
SMS Lifesciences India Limited is engaged in the business of manufacturing Active Pharmaceutical Ingredients and their intermediates. The company has manufacturing facilities at Kazipally and Jeedimetla, and its Research and Development centre is located at Sanatnagar, Hyderabad.
Written by Shivani Singh
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