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Alembic Pharma gets USFDA nod for its antibiotic capsules

Press Trust of India  |  New Delhi 

Drug firm today said it has received approval from the US health regulator for its Hyclate capsules used for treatment of wide variety of

The approval from the Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Hyclate capsules USP, in the strengths of 50 mg and 100 mg, said in a filing to BSE.

The product is generic version of Pfizer Inc's Vibramycin capsules in the same strengths, it added.

"Hyclate capsules USP, 50 mg and 100 mg, have an estimated market size of USD 80 million for twelve months ending December 2017, according to IQVIA," said.

The company currently has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from USFDA, it added.

Shares of today closed at Rs 506.55 per scrip on BSE, up 3.32 per cent from its previous close.

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

First Published: Thu, June 14 2018. 17:00 IST