Dr Reddy's Laboratories has announced the launch of Montelukast Sodium Oral Granules, a bioequivalent generic version of Singulair® (montelukast sodium) oral granules in the US market, following the approval by the United States Food & Drug Administration (USFDA) of Dr.Reddy's ANDA for Montelukast Sodium Oral Granules.
The Singulair Oral Granules brand had U.S. sales of approximately $61 million for the most recent twelve months ending July 2012 according to IMS Health.
Dr. Reddy's Montelukast Sodium Oral Granules in 4 mg are available in unit dosage package of 30.
Dr. Reddy's Laboratories Ltd is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand.