Strides Pharma Science’s stepdown wholly owned subsidiary--- Strides Pharma Global, Singapore, has received approval for Sevelamer Carbonate Tablets, 800 mg, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Renvela Tablets, 800 mg, of Genzyme. Sevelamer Carbonate is a phosphate binder, that helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.Sevelamer Carbonate Tablets, 800 mg has a market size of $181 million as per IMS. This approval further strengthens the company's presence in the Sevelamer portfolio, complementing the existing approval of Sevelamer Carbonate Powder for Oral Suspension, which has a market size of $23 million. The Sevelamer tablets will be manufactured at the company’s facility in Puducherry.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 245 plus ANDAs have been approved. The company has set a target to launch around 60 new products over three years in the US.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1808.50 |
Dr. Reddys Lab | 1342.45 |
Cipla | 1472.45 |
Lupin | 2147.55 |
Zydus Lifesciences | 973.90 |
View more.. |