Glenmark, Cipla get US nod for inhaler drug

Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana.

The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for chronic bronchitis, emphysema and other chronic obstructive pulmonary diseases.

Three weeks ago, another Indian drug manufacturer, Lupin, had announced the launch of the same drug, arformoterol tartrate, in the US in the same 15mcg/2ml dosage.

For Glenmark, this marks the first approval of a nebulizer product.

The company said it will manufacture the drug at its US-based facility based in Monroe, North Carolina.

Cipla said its stocks are ready for shipping immediately.

Established in 1935, Cipla is a global pharmaceutical company focused on respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments, and has its key operations in India, South Africa and North America. It exports to over 80 countries.

The company has 46 manufacturing sites around the world produce over 50 dosage forms and over 1,500 products.