Synopsis:
The shares of this pharma company will be in focus today, as the company in its announcement has stated that the US FDA has approved their ranitidine tablets, and they will be re-entering the US market once again.
The shares of this company, which is a diversified and integrated pharmaceutical company with interests in Active Pharmaceutical Ingredients (API) and Intermediates, are in the news today following the company’s announcement of the approval of its reformulated tablets by the US FDA, which marks a re-entry for the company in the US.
With a market cap of Rs 2,701 crore, the shares of SMS Pharmaceuticals Ltd gained more than 8% and reached a high of Rs 297.25 when compared to its previous day closing price of Rs 274. The shares are trading at a PE of 33.5, whereas its industry PE is 31.1, and the shares have given a return of 230% over the last 5 years.
About the FDA approval and market re-entry.
The US FDA’s approval of VKT Pharma’s reformulated ranitidine marks an important step forward for the company and the molecule itself. After being withdrawn from the US market five years ago due to NDMA-related concerns, the product’s return reflects the substantial work undertaken to rebuild its safety profile. The team has strengthened the formulation, upgraded manufacturing controls, and enhanced testing systems to address every issue raised earlier, ensuring the medicine now meets today’s higher regulatory expectations.
This approval allows the company to re-enter a major gastrointestinal therapy segment in the US and reaffirms its ability to deliver products that meet global compliance standards. It also signals renewed confidence from regulators and supports the company’s long-term plan to strengthen its international footprint through scientifically robust and responsibly developed products.
Financials and others
The revenue from operations for the company rose from Rs 197 crore in Q2 FY25 to Rs 242 crore in Q2 FY26, showcasing a YoY growth rate of 23%; the profit also grew by 78%, increasing from Rs 14 crore in Q2 FY25 to Rs 25 crore in Q2 FY26.
SMS Pharmaceuticals has grown from a small, single-product facility in 1990 into a multi-location API manufacturer with a footprint that spans several therapeutic areas. Over the years, the company has built its reputation on strong research capabilities, modern manufacturing facilities, and a commitment to quality that earned it export house status as early as 1997–98.
Today, with four manufacturing units, two research centres, and more than 1,000 employees, SMS Pharma serves a steadily expanding base of customers in India and abroad. Its journey reflects steady growth, widening expertise, and an ability to evolve with the needs of the global pharmaceutical industry.
The company works with some of the most trusted names in global and Indian pharma, including Teva, Sanofi, Johnson & Johnson, Cipla, Sun Pharma, Dr Reddy’s, Zydus, Aurobindo, and Laurus Labs. This wide and respected customer base shows the confidence major players place in the company’s quality, reliability, and ability to deliver consistently across regulated markets.
Written by Leon Mendonca
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