Strides Pharma Gets USFDA Nod to Sell Antihistamine Tablets in US

The US market for Cyproheptadine Hydrochloride Tablets USP, 4 mg is nearly $20 million, if one goes by the IQVIA data. And it’s fast growing. Now, Strides Pharma Global Pte. Ltd, a wholly owned subsidiary of BSE and NSE listed Strides Shasun Limited, will market Cyproheptadine Hydrochloride Tablets USP, 4 mg in the large and fast-growing US market. Normally when one suffers from allergy symptoms like watery eyes, runny nose, sneezing, hives, and itching, one uses Cyproheptadine Hydrochloride Tablets, which are antihistamines.

 

Strides Pharma Global Pte. Ltd. has received approval for Cyproheptadine Hydrochloride Tablets USP, 4 mg from the United States Food & Drug Administration (USFDA). It is pertinent to mention here that Cyproheptadine Hydrochloride Tablets is a generic version of Periactin Tablets of Merck & Co. Inc. Interestingly, the product, which Strides Pharma Global Pte. Ltd will be marketing in the US market, will be manufactured at the company’s Oral dosage facility at Bangalore.

 

At present, the company has 74 cumulative ANDA filings with USFDA. Out of these, 46 ANDAs have been approved as of date and 28 are pending approval. The company, which at present has as many as 7 manufacturing bases spread across three continents including 5 USFDA-approved facilities and 2 facilities for the emerging markets, is a vertically integrated transnational pharmaceutical company headquartered in Bangalore. It has two business verticals: regulated markets and emerging markets.

The company also has strong R&D infrastructure in India with global filing capabilities and a strong commercial footprint spread across 100 countries.