Strides Shasun has announced that it will launch ranitidine tablets USP, 75 mg (OTC) for the US markets. The new launch further strengthens 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. Strides 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 US$ 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 US FDA including its JV with Vivimed of which 51 ANDAs have been approved as of date and 31 are pending approval.
Ranitidine belongs to a class of drugs known as H2 histamine blockers. It is used to treat peptic ulcers of the stomach and intestines and gastroesophageal reflux and heartburn related to indigestion.