Strides Pharma experienced a notable surge in stock prices, climbing 3.20% to reach an intraday peak of Rs 858.10 on Friday. This uptick was spurred by the U.S. Food and Drug Administration’s approval of its Sevelamer carbonate tablets, a significant development in the treatment of Hypocalcemia, associated with chronic kidney disease.
The approved Sevelamer Carbonate 800 mg tablets are designed to control elevated phosphate levels in the bloodstream, a common issue for those suffering from chronic kidney conditions. This product is both bioequivalent and therapeutically equivalent to the Reference Listed Drug, Renvela tablets, which are also 800 mg and produced by Genzyme.
This approval not only boosts Strides Pharma’s portfolio but also taps into a substantial market, with the Sevelamer product line including both tablets and oral suspension powder. According to IMS data, the tablet market alone is estimated to be worth $181 million, with the oral suspension powder targeting an additional $23 million market.
Strides Pharma will manufacture the Sevelamer tablets at its Puducherry facility, one of its numerous manufacturing sites spread across four continents. The company’s global operations include eight manufacturing facilities, five of which are FDA-approved and located in the United States. The company also maintains facilities in Chennai, two in Bengaluru, as well as international sites in Milan, Nairobi, and New York.
Furthermore, Strides Pharma, headquartered in Bengaluru, continues to expand its global presence in both regulated and emerging markets. With a total of 260 cumulative abbreviated new drug application (ANDA) filings with the US FDA, over 245 have already been approved. Additionally, the company recently expanded its portfolio through the acquisition of assets from Endo at Chestnut Ridge, reinforcing its competitive edge in the pharmaceutical industry.
As part of its ambitious growth strategy, Strides Pharma has outlined plans to launch around 60 new products in the US market over the next three years. This aggressive expansion underscores the company’s commitment to enhancing its product offerings and securing a stronger foothold in the competitive pharmaceutical sector.
By the afternoon trading session, Strides Pharma’s shares were up by 1.59% at Rs 844.70, outperforming the S&P BSE Sensex, which saw a modest increase of 0.04% to 72,434.47.
Key Takeaways
- Strides Pharma received approval from the US FDA for its Sevelamer Carbonate tablets used in treating Hypocalcemia in chronic kidney disease patients.
- The company capitalized on this opportunity, addressing a combined market potential of over $200 million for its Sevelamer products.
- Manufacturing will take place in Strides Pharma’s Puducherry facility, part of a vast global manufacturing network.
- Strides Pharma plans to introduce approximately 60 new products in the US within the next three years, demonstrating its robust growth strategy.
Conclusion
The recent FDA approval represents a significant milestone for Strides Pharma, not only enhancing its product portfolio but also solidifying its market position in the pharmaceutical industry. This development promises substantial growth prospects and is expected to contribute positively to the company’s performance in the coming years. As Strides Pharma continues to expand and innovate, it remains poised for further success in a competitive global market.
