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.

Glenmark will follow a mix of para III and para IV filings to optimise its risk-reward equation in the US market. Two ANDA filings are expected in FY04E and the company plans to increase it to five-six, each year, from FY05.

The company expects revenues from ANDA filings to start accruing from FY06E, the report said. Glenmark is also investing in research and development (R&D) in a major way to ensure sustained growth in the post-GATT scenario. It is striving to be a leading research-driven pharmaceutical company and has initiated new chemical entity (NCE) research three years ago and has five NCEs in the pipeline which it plans to out-license.

It is currently focussing on areas such as diabetes/obesity (Beta-3 agonists) and asthma (PDE-4inhibitors). Glenmark expects to finish pre-clinical trials on the asthma molecule by December 2003 and begin clinical trials in early 2004. Its pre-clinical trial for the diabetes molecule is expected to get over in early 2005.

The company''s R&D spend, which was 4.4 per cent in FY03, is expected to rise to 5-8 per cent in FY04, the report said. Also Glenmark is one of the fastest-growing companies in the domestic formulations market. This growth has been achieved through aggressive new product launches and a focus on speciality segments like dermatology, gynaecology, respiratory and diabetes which contribute a significant 69 per cent to its domestic formulations.

The company has outpaced industry growth during the past five years and has moved up to the 24^th position in the domestic formulations market from 40^th in 1998 and intends to improve it to 20^th by 2005, ICICI Securities report said.