Alembic Pharma gets USFDA nod for its antibiotic capsules

The approval from USFDA is for the company's abbreviated new drug application (ANDA) in the strengths of 50 mg and 100 mg, Alembic Pharma said.


Drug firm Alembic Pharmaceuticals today said it has received approval from the US health regulator for its Doxycycline Hyclate capsules used for treatment of wide variety of bacterial infections.

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

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

“Doxycycline 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,” Alembic Pharma said.

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

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


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