Date:15/06/2004 URL: http://www.thehindubusinessline.com/2004/06/15/stories/2004061501730200.htm

Back Aarti Drugs files six molecules for USFDA nod

Our Bureau

Mumbai June 14

AARTI Drugs Ltd (ADL), a research-driven company engaged in the development and manufacturing of APIs, bulk drugs and intermediates, has filed applications for USFDA approvals for six new molecules in different therapeutic segments such as anti-diarrhoea, cardiovascular, anti-diabetic, sedatives and anti-depressant. This forms part of the company's plans to tap the opportunities in the post-WTO regime.

ADL, which introduces and commercialises at least 15 molecules every year, at present, has 12 new chemical entities (NCEs) in advance stages of development. Further, according to a senior official of the company, its research and development division has already filed four DMFs (Drug Master Files) for the regulated markets and one DMF for custom synthesising a new product for a large MNC pharmaceutical company.

The company, which has established a presence in the anti-diarrhoea and anti-inflammatory therapeutic groups with products such as Tinidazole, Metronidazole, Nimesulide, Rofecoxib, is the largest producer of benzene-based basic and intermediate chemicals in India. It commands leadership position with over 70 per cent market share of products such as secnidazole, ornidazole and metronidazole, in the anti-diarrhoea therapeutic segment in India.

ADL has also filed for Certificate of Suitability (COS) for three products — Tinidazole, Ticlopidine HCL and Ranitidine HCL — for the European markets. "We are expecting to receive the COS approval for Metronidazole and for Diclofenac Sodium very shortly," the official said.

The company had recently bagged the COS approval from the European Directorate for the Quality of Medicines (EDQM) for three of its drugs — Nimesulide, Tolnaftate and Zolpidem Tartrate. With this, ADL will now be able to market these drugs directly in the developed markets of Europe, which would significantly improve its realisation.

According to the official, the company, in an effort to further reinforce its research capabilities, is considering acquiring research facilities in India and abroad, besides looking at other niche FDA-approved API players for a possible takeover in countries such as China and Brazil. "We have set aside about Rs 15 crore for this purpose," the official said.