New Delhi: Drug firm Strides Shasun announced that it will launch Ranitidine Tablets USP, 150 mg, used to treat peptic ulcers of the stomach and intestines, in the US markets.
Strides is already a key player in the US Ranitidine Rx market with 32 percent market share through its approval for Ranitidine Tablets USP, 150 mg, and 300 mg. The new launch will further strengthen company’s 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 company s 50:50 JV with Vivimed Labs. The product will be backward integrated and will be manufactured at the JV s oral dosage facility in Chennai, it said.
Strides will have exclusive marketing rights for the product in the US. The product will be launched immediately.
The company has 82 cumulative ANDA filings with USFDA (including its JV with Vivimed), of which 50 ANDAs have been approved as of the date and 32 are pending approval.