Strides Shasun gets USFDA approval for Cyproheptadine Hydrochloride Tablets
Strides Shasun’s wholly-owned subsidiary Strides Pharma Global Pte. Ltd. has received approval for Cyproheptadine Hydrochloride Tablets from the United States Food & Drug Administration (USFDA), keeping its ANDA approval momentum intact.
Cyproheptadine Hydrochloride Tablets is an antihistamine used to treat allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching. According to IQVIA data, the US market for Cyproheptadine Hydrochloride Tablets USP, 4 mg is approximately US$ 20 million.
The company is well-positioned in the market as consistency in compliance indicates minimal regulatory risk in the US market where other peers face difficulties. The company has 74 cumulative ANDA filings with USFDA, out of which 46 ANDAs have been approved and 28 are still awaiting.
Strides Shasun has a global manufacturing footprint with seven manufacturing facilities spread across three continents including five USFDA approved facilities and two facilities for the emerging markets.
On Thursday, the stock of Strides Shasun opened at Rs. 654 per share and touched an intra-day low of Rs. 632, on the BSE.