The Hyderabad-based Granules India Limited has entered into an agreement with Par Pharmaceutical Inc, a subsidiary of Endo International Plc, to market the generic version of OTC omeprazole and sodium bicarbonate in North America. The company expects the approval from the US Food and Drug Administration (FDA) for this generic heart burn drug in July 2016.
“Granules is excited that, through this exclusive agreement with Par Pharmaceutical, we can strengthen our OTC product basket and widen our offerings in the North American store brand market for meeting retailers' and consumers' desire for competitive market choices and alternatives,” said Krishna Prasad Chigurupati, chairman and managing director of Granules India.
Par Pharmaceuticals’ omeprazole and sodium bicarbonate is the generic equivalent of Merck/ MSD Consumer Care’s Zegerid OTC.
Omeprazole is a proton pump inhibitor (PPI) that decreases the production of stomach acid. Sodium bicarbonate is an antacid that raises stomach pH to keep the omeprazole from breaking down in stomach acid.