Synopsis:
SMS Pharmaceuticals announced the successful closure of USFDA inspection at its Hyderabad lab. Conducted June 23-25, 2025, the audit ended with zero Form 483 observations; EIR issued with “No Action Indicated” status.
During Thursday’s trading session, shares of a diversified and integrated pharmaceutical company specialising in API and intermediates surged nearly 10.5 percent on BSE, after receiving an Establishment Inspection Report (EIR) for central laboratory analytical services.
At 10:33 a.m., the shares of SMS Pharmaceuticals Limited were trading in the green at Rs. 244.95 on BSE, up by nearly 6 percent, as against its previous closing price of Rs. 231.25, with a market cap of Rs. 2,171.5 crores. The stock has delivered negative returns of over 28 percent in the last one year, but has gained by about 2 percent in the last one month.
What’s the News
According to the latest regulatory filings on the stock exchanges, SMS Pharmaceuticals Limited announced the successful closure of the recent inspection by the USFDA at its Central Laboratory Analytical Services in Gagillapur, Hyderabad, with the receipt of the Establishment Inspection Report (EIR).
The inspection, carried out between 23rd June to 25th June 2025, concluded with zero Form 483 observations. The company has received the Establishment Inspection Report (EIR) with a “No Action Indicated” (NAI) status, officially confirming the closure of the audit.
Financials & more
SMS Pharma reported a significant growth in its revenue from operations, showing a year-on-year increase of around 19 percent from Rs. 164 crores in Q1 FY25 to Rs. 196 crores in Q1 FY26. Similarly, its net profit increased during the same period from Rs. 16 crores to Rs. 20 crores, representing a rise of about 25 percent YoY.
The company is targeting a global-scale production capacity of 1,000 MT of ibuprofen per month. It plans to add 8-10 new products over the next 12-18 months across existing and new therapeutic areas. Additionally, a Rs. 250 crore capex is earmarked for capacity expansion for existing and new products, R&D facility and CMO business.
SMS Pharmaceuticals Limited is engaged in the business of manufacturing active pharmaceutical ingredients and their intermediates. It operates Asia’s largest single-block Ibuprofen facility, with regulatory markets contributing 88 percent of its FY25 revenue.
The company operates two state-of-the-art manufacturing facilities in Hyderabad and Vizag, with capacities of 120 KL and 3,000 KL, respectively. Additionally, SMS Pharma has a proven track record of delivering quality products across a diversified portfolio of therapeutic segments.
It has manufacturing facilities at Bachupally (Hyderabad) and Kandivalasa Village (Andhra Pradesh). Apart from manufacturing facilities, the company has a Research & Development (R&D) Centre at Gagillapur (Hyderabad).
Written by Shivani Singh
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