Aurobindo Pharma Limited, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received tentative approval for donepezil hydrochloride tablets in 5mg and 10mg strengths from the US Food and Drug Administration (US FDA). The product has a market size of over $1.9 billion.
Donepezil hydrochloride tablets 5mg and 10mg, the generic equivalent of ‘Aircept’ tablets of Eisai Medical Research Inc, are indicated for the treatment of mild, moderate and severe dementia of the Alzheimer’s type and fall under the central nervous system (CNS) therapeutic segment.
With this tentative nod, Aurobindo now has 99 abbreviated new drug application (ANDA) approvals from the US FDA, the company said in a press release on Wednesday.
The scrip of Aurobindo is currently trading at Rs 540 on the BSE, down 1.37 per cent as against the previous close of Rs 547.50.
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