Alembic Pharma gets FDA approval for Zolmitriptan tablets

The Dollar Business Bureau

Alembic Pharmaceuticals, a leading pharma company in India, has received the US Food and Drug Administration (USFDA) nod for selling Zolmitriptan Orally Disintegrating tablets in the US market. These medicines are used in the treatment of migraine.

“The company has received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5 mg,” Alembic Pharmaceuticals said in a filing to BSE.

The drug is a therapeutic equivalent to Zolmig-ZMT Orally Disintegrating tablets, the reference listed drug product (RLD) of the company AstraZeneca Pharmaceutical in the same strengths, the release added.

These Zolmitriptan tablets are used for acute treatment of migraines in adults, the company said.

Currently, the company has approvals for 51 ANDA from USFDA, including 45 final and 6 tentative.

Alembic Pharmaceuticals reported a net sales of Rs.879 crores during the second quarter of current fiscal ended on September 30. The net profit of the company in the given quarter stood at Rs.119 crores.

During the quarter July-September 2016, the international formulation business of the company recorded a business of Rs.352 crores.