Strides Shasun has entered into a 50:50 joint venture with Vivimed Labs to launch ranitidine tablets USP, 150 mg (OTC) in the US markets.
 
The Bengaluru-based company is already a key player in the US ranitidine Rx market with 32% market share through its approval for ranitidine tablets USP, 150 mg and 300 mg. The new launch will further strengthen company’s ranitidine franchise. According to IRI data, 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. Strides will have exclusive marketing rights for the product in the US. The product will be launched immediately, stated a communication from Strides.
 
The company has 82 cumulative ANDA filings with US FDA including its joint venture with Vivimed of which 50 ANDAs have been approved as of date and 32 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.