Glenmark Pharmaceuticals plans major foray into US markets

Pradeep Rane
08 October 2003

Mumbai: Glenmark Pharmaceuticals is bracing to make a foray into the US markets in a big way.

As part of its efforts to enter the US markets, Glenmark is upgrading its Ankleshwar plant, acquired from GSK, to US Food and Drugs Administration (FDA) standards with additional capex of Rs 70-80 million. The company will be filing drug master files (DMFs) from this plant. It has set up a subsidiary in the US.

While the company has so far exported only to the unregulated markets, it will be moving up the value chain by targeting the highly regulated but lucrative US markets, company officials said at a conference organised by ICICI Securities in the US.

The company has put in a structure as part of its preparatory plan for the US markets. Glenmark has recently made its first DMF. This was for Amiodarone, a cardiovascular drug. The drug has a market size of $500 million and is growing at 12 per cent annually.

Sales of the bulk drug for Amiodarone will begin in Q1FY05E and is expected to translate into revenues of $34 million with margins in excess of 30 per cent. Glenmark is expected to file four more DMFs in FY04E, the ICICI Securities report said.

Glenmark recently entered into a marketing pact with Lannett Co Inc. The pact envisages five abbreviated new drug application (ANDA) filings over the next two years and provides Glenmark access to Lannett''s distribution network and its USFDA-approved manufacturing facilities. The ANDAs will be owned by Glenmark Pharma Inc.