Strides Pharma wins FDA approval for kidney drug Sevelamer Carbonate

In a major coup for Strides Pharma Science Limited, the company’s stepdown wholly-owned subsidiary, Strides Pharma Global Pte. Limited in Singapore, has scored approval from the United States Food & Drug Administration (FDA) for its Sevelamer Carbonate for Oral Suspension USP, 0.8g and 2.4g. The approval secures Strides Pharma’s position in the Sevelamer Carbonate market, valued at approximately $ 212 million per IQVIA. The product, which will be manufactured at the company’s Bengaluru facility, is bioequivalent and therapeutically equivalent to Genzyme’s Reference Listed Drug (RLD), Renvela for Oral Suspension, 0.8g and 2.4g.

Elevating Strides Pharma’s portfolio, this latest USFDA approval completes the company’s offering in the Sevelamer Carbonate sector. This market for both Tablets and Oral Suspension comes with a combined opportunity of around US$ 212Mn, according to IQVIA data. Strides Pharma plans to leverage this market by manufacturing the approved Sevelamer Carbonate product at their Bengaluru facility. Limited players in the market offer both the Tablets and Oral Suspension forms, making Strides Pharma’s approved portfolio a significant entrant.

The company has 280 cumulative ANDA (Abbreviated New Drug Application) filings with the USFDA, including the recently acquired portfolio from Endo at Chestnut Ridge, and over 260 of these ANDAs have already received the green light from the USFDA. Strides Pharma is further expanding its footprint in the US market by setting a target to launch approximately 60 new products over the next three years.

For those unfamiliar with the medication, Sevelamer Carbonate for Oral Suspension is a crucial treatment for managing elevated levels of phosphate in the blood, particularly for patients suffering from chronic kidney disease. The drug acts by binding to dietary phosphate upon consumption after a meal, effectively preventing its absorption and thereby managing overall phosphate levels in the blood.

This milestone FDA approval not only enhances Strides Pharma’s Sevelamer Carbonate portfolio but also reaffirms the company’s robust capabilities in bringing complex generics to the market. With this approval, Strides Pharma Science Limited continues its trajectory toward becoming a key player in the lucrative US pharmaceutical landscape.