Indian drug for dementia gets US regulatory nod

Bengaluru, May 24
Indian drug-maker Strides Shasun Ltd has got approval of the US regulator for its Memantine Hydrochloride tablets to treat Alzheimer's-type dementia, said the company on Wednesday.

In a regultory filing on the BSE, the city-based company said the US Food & Drug Administration (USFDA) has approved its 5mg and 10mg Memantine Hydrochloride tablets for treating moderate to severe Alzheimer's-type dementia.

"The US market for Memantine Hydrochloride tablets is about $60 million. The product will be manufactured at our flagship facility in Bengaluru and marketed by Strides Pharma Inc in the US at the earliest," said the filing.

As an integrated global pharmaceutical firm, Strides Shasun has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Active Pharmaceutical Ingredients.

The company has manufacturing footprint with eight plants across three continents, including six US FDA-approved facilities and two for the emerging markets.

The company also has three R&D facilities in India, with global filing capabilities and a commercial footprint across 85 countries.