Strides Shasun Limited today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg.
According to IMS data, the US market for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg is approximately USD 60 Million. The product will be manufactured at the Company’s flagship facility at Bangalore and marketed by Strides Pharma Inc in the US Market. The product will be launched immediately.
Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe Alzheimer-type dementia.
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. The Company has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries.
