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Alembic Pharma gets USFDA nod for anti-depression drug

Press Trust of India  |  New Delhi 

has received the US health regulator's nod for Hydrochloride tablets, used for treatment of disorder.

"The company has received approval from the Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Hydrochloride tablets," said in a filing.

The approval is for strengths of 75 mg and 100 mg.

The approved product is therapeutically equivalent to the reference listed (RLD) of

Quoting IMS December 2017 data, the company said Hydrochloride tablets had an estimated market size of USD 37 million.

The company now has a total of 72 ANDA approvals from the USFDA.

The stock was trading at Rs 467.40 apiece, up 7.49 per cent, on the

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, June 11 2018. 11:15 IST
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