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Sharon Bio-Medicine files ANDA for Memantine Hydrochloride Tablets

13 Feb 2012 Evaluate

Sharon Bio-Medicine has filed its ANDA for Memantine Hydrochloride Tablets, 5mg and 10mg tablets from its drug product manufacturing facility at Silaqui, Dehradoon, Uttarakhand. The company has also filed its own DMF for the drug substance which will be used in manufacturing of the drug namely Memantine Hydrochloride from its drug substance manufacturing facility at Taloja, Navi Mumbai.

Memantine Hydrochloride Tablets are the generic version of the Namenda Tablets manufactured by USA based- Forest Laboratories, used for the treatment of moderate to severe dementia of the Alzheimer’s type.

With this integrated filing of the drug master file and the ANDA, Sharon expects the approval of both of its manufacturing facility by September 2012, post inspection of the manufacturing facility by USFDA.

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