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Mumbai, May 8: : Glenmark Pharmaceuticals has set up a wholly-owned subsidiary in the US to make further inroads into the US market for the company’s formulations and active pharma ingredients market.
The company has appointed Jeffrey Weiss as chief executive officer (CEO) of the subsidiary, which will be based in Princeton, New Jersey. Mr Weiss said the the entity would act as a front end for the Glenmark’s global business. He brings with him over 15 years of experience in the pharma industry in the US and has worked with Dr Reddy’s and Ranbaxy in the US along with Akzo Nobel and Pliva Inc.
The company plans to file 2-3 abbreviated new drug applications (ANDA) over the next 18-24 months in the US market along with 4-5 drug master files (DMFs), which are already off-patent, Glenmark Pharma managing director and CEO Glenn Saldanha said.
The company would file its first DMF application with US drug authorities in the second quarter of current fiscal. It is also working to get US Food and Drug Administration certification for Ankleshwar plant in Gujarat, he said.
Significant revenue from the filing of ANDAs will come only 2005-6, however, filing of DMFs would trigger revenue next year. The ownership of ANDA will reside with Glenmark while the alliance partner will manufacture them in the US, he added.
Commenting on the alliance model, Mr Saldanha said that the company has diversified out of the regulatory risk by opting for this model. On the two research molecules — PD4 and 1087 — he said that both the molecules are scheduled to enter phase-I clinical trials at the end of the year or early next year.
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