Morepen Laboratories Limited has submitted a Drug Master File (DMF) for the $ 700 mn. Molecule - Desloratadine (Clarinex), a metabolite of Loratadine, in the US. Desloratadine, an antiallergic drug has longer lasting relief as compared to Loratadine.

This is a significant move since it is the first ever DMF filed for Desloratadine for US Market by any company since the launch of the product by innovator. Morepen was also the first Indian company to file a USDMF for the drug's basic compound Loratadine in September 1997 and had Para IV filing through its partner Novartis.

According to Mr. Sushil Suri, CMD Morepen Laboratories, "The filing of USDMF for Desloratadine is particularly important for Morepen, since it will help consolidate the company's hold on the Loratadine API franchise in the US where it already enjoys around 90% market share outside the innovator".

While Loratadine has been switched to OTC drug in USA, Desloratadine continues to be a prescription drug, which is having higher realizations in the market. The filing of US DMF for Desloratadine is likely to help Morepen make up for the revenues lost as a result of Loratadine shifting to the OTC segment, Mr. Suri said.

Desloratadine is manufactured in Morepen's USFDA approved plant in Masulkhana where Loratadine is currently produced. The company also holds an international patent for Desloratadine, which was published recently by World Intellectual Property Organization (WIPO) under the Patent Co-operation Treaty (PCT). It was for a high yielding process for manufacturing a very stable crystalline form of this anti-allergic drug. Patented by Morepen, this process is one of the most competitive option, both in terms of cost and quality, for this category of drugs.

Morepen has been on a revival and comeback trail and the Desloratadine DMF is the first in a series of DMFs after Loratadine, which Morepen has planned to file.

Morepen Laboratories Limited (MLL) is a preferred generic manufacturer of bulk drugs internationally and the largest generic manufacturer of Loratadine in the world. With three high-tech plants at Himachal, MLL exports to over 50 countries, including the highly regulated markets of the US, Western Europe and Canada. A leadership position in its core business of bulk drugs, adherence to international quality standards with USFDA approved facilities and a strong R & D base gives Morepen the cutting edge required to meet the demands of an economy poised to enter the GATT regime. Besides bulk drugs, Morepen is a professionally managed, R & D based company that is also engaged in manufacturing and marketing of Formulation dosage forms. Morepen has also made a foray into the self-health category with Dr. Morepen - its FMHG brands.