Strides is already a key player in the US Ranitidine Rx market with 32 per cent market share through its approval for Ranitidine Tablets USP, 150 mg and 300 mg. The new launch will further strengthen companys Ranitidine franchise, the company said in a statement.
The company said, "the US OTC market for Ranitidine Tablets, which is the generic form of the popular brand Zantac, is approximately USD 200 million."
This is the first product approval from companys 50:50 JV with Vivimed Labs. The product will be backward integrated and will be manufactured at the JVs oral dosage facility in Chennai, it said.
The company has 82 cumulative ANDA filings with USFDA (including its JV with Vivimed), of which 50 ANDAs have been approved as of date and 32 are pending approval.
Shares of Strides Shasun were trading 2.52 per cent higher at Rs 710.35 apiece on BSE.