Glenmark Pharma’s partner gets USFDA’s nod for generic methadone hydrochloride tablets

07 Aug 2018 Evaluate

Glenmark Pharmaceuticals’ partner Elite Pharmaceuticals, Inc., a US specialty pharmaceutical company, has received approval from the US Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for methadone hydrochloride 5 mg and 10 mg tablets.

Methadone is indicated for the management of pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate. Methadone can also be used for maintenance treatment of opioid addiction (heroin or other morphine-like drugs) in conjunction with appropriate social and medical services.

Glenmark Pharmaceuticals, Inc., Elite's marketing alliance partner, will sell and distribute methadone for Elite for which Elite will receive manufacturing and license fees. Based on Quintiles IMS Health data, the annual retail sales for the brand and generic products were around $30 million.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).


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