FDA nod to Strides Shasun for dementia drug

24 May 2017 | News

The product will be manufactured at the company’s facility at Bengaluru and marketed by Strides Pharma Inc in the US market.

Strides Shasun received approval from the US health regulator United States Food and Drug Administration (USFDA) for memantine hydrochloride tablets used in the treatment of dementia.

The product will be manufactured at the company’s facility at Bengaluru and marketed by Strides Pharma Inc in the US market. The product will be launched immediately.

The US market for memantine hydrochloride tablets USP, 5mg and 10 mg is approximately USD 60 million.

Memantine hydrochloride belongs to a group of medicines called (NMDA)-receptor antagonists. It acts on these (NMDA)-receptors for improving the transmission of nerve signals and the memory.

The Company has global manufacturing foot print with 8 manufacturing facilities spread across three continents including 6 US FDA approved facilities and 2 facilities for the emerging markets.

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