Glenmark Pharmaceuticals Ltd has announced that the Company has received US FDA approval to market Meloxicam oral tablets 7.5 mg and 15 mg, a generic version of Boehringer Ingelheim´s brand Mobic. The drug belongs to a category of Non-steroidal Ainti-inflammatory Drugs [NSAID] and is prescribed for the indication of Osteoarthritis with annual sales of about USD 936 million. The generic will be marketed by the Company´s US subsidiary, Glenmark Pharmaceutical Inc., which will commence supplying the generic drug to customers in the US immediately.
The Company is manufacturing the drug at its solid-oral formulation facility at Goa; this is the third ANDA filed by Glenmark from the Goa facility that has received US FDA approval after Fluconazole and Zonisamide. The Company currently markets 7 products in the US with the last launched product being Codeine Phosphate, a controlled substance.