Glenmark Pharmaceuticals, Inc., USA the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride tablets: 4 mg (base), 8 mg (base) and 24 mg (base). Ondansetron Hydrochloride tablets are the generic version of GlaxoSmithKline's Zofram tablets.
Ondansetron Hydrochloride belongs to a category of antiemetics and is prescribed to help control nausea and vomiting; the drug had annual sales of about USD 640 million, based on IMS data for the 12 months ending June 30, 2006
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.
The company is also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc].