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Glenmark receives US FDA approval for Meloxicam

New Delhi, Jul 20: Glenmark Pharmaceuticals today received US Food and Drug Administration approval to market Meloxicam 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 Anti-inflammatory Drugs (NSAID) and is prescribed for the indication of Osteoarthritis with annual sales of about 936 million dollars.

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 manufactures 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 seven products in the US with the last launched product being Codeine Phosphate, a controlled substance.

Earlier, Ahmedabad-based Zydus Cadila Healthcare also said it received an approval from the US FDA to market the same tablets in US market.

UNI

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