The Hindu Business Line : Glenmark's Ankleshwar unit gets FDA nod

GLENMARK Pharmaceuticals said on Tuesday that it has received the approval of the US Food and Drug Administration (USFDA) for its Ankhleshwar plant that manufactures active pharmaceutical ingredients (APIs).

The Ankleshwar facility was acquired by Glenmark from GlaxoSmithKline (GSK) in 2001 and has since been upgraded to meet USFDA standards, a company communication said.

The facility was inspected in May 2004 for two of its drug master files (DMF) in the segments related to heart and internal medicine - Amiodarone and Cilastazol, respectively. Subsequently, the DMFs for the two products were filed in the second half of 2003.

A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Supplies of the two APIs to clients in the US are expected to begin later this year, the Glenmark note said.

The company has already filed four DMFs from the facility till date including the two approved products. The company expects to file another 8-10 DMFs from the Ankhleshwar facility in this financial year.

According to Mr Glenn Saldanha, Managing Director and CEO, the approvals would help the company build on the growth delivered by the API business in the first quarter of this year, by tapping the profitable regulated markets.

Glenmark already has tie-ups with three players in North America — Apotex, Eon Labs and KV Pharmaceuticals — for the supply of APIs.

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