Strides Shasun is planning to launch Ranitidine Tablets USP, 75 mg (OTC) for the US markets. The new launch will further strengthen Strides’ Ranitidine portfolio that now includes Ranitidine Tablets 150 mg and 300 mg in the Rx space and Ranitidine Tablets 75 mg and 150 mg in the OTC space. The company is already a key player with 32% share of the US Rx market for Ranitidine. According to IRI data, the US OTC market for Ranitidine Tablets, which is the generic form of the popular brand Zantac, is approximately $200 million.
This is the second 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. 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 51 ANDAs have been approved as of date and 31 are pending approval.
Strides Shasun (formerly known as Strides Arcolab) is engaged in manufacturing, sale and export of pharmaceutical products. It offers general tablets, hard gelatin and soft gelatin capsules, sachets, potent drugs and semi-solids.
