The Hindu Business Line : Morepen filing 6 new drug master files

MOREPEN Laboratories Ltd is once again gearing up for the US markets by filing six more drug master files (DMFs) in the next six months for treating various stress-related ailments such as diabetes, cholesterol and cardiac problems.

With these new initiatives, the company hopes to increase its turnover by 50 per cent for the financial year October 2004-September 2005. For the fiscal ending September 30, 2004, it expects a turnover of Rs 100 crore.

While the company has already filed an application for anti-allergy drug Desloratadine, it will enter the anti-diabetics market with its insulin sensitiser, Pioglitazone Hydrochloride. Speaking to Business Line, Mr Sushil Suri, Chairman and Managing Director, Morepen Laboratories said, "The annual sales for this oral diabetes drug in the US is $1.7 billion with a growth rate of 18 per cent. We expect to garner a market share of 10-15 per cent of the generics market for the product in the next few years."

Besides this, the company is also planning to file DMFs for three cholesterol busters, Atorvastatin, Fluvastatin and Simavastatin. "Currently, companies such as Ranbaxy and some others have already filed DMFs for Atorvastatin and Simvastatin, but we will be the first for Fluvastatin," said Mr Suri.

In the asthma category it is planning to enter the Montelukast segment. He added that the company would enter into tie-ups for supply of these active pharmaceutical ingredients (API).

The company will also look at possibilities of launching some of the products on its own in the US markets. "We will file at least three abbreviated new drug approvals (ANDAs) by June next year," said Mr Suri. Morepen Labs will now look at targeting the mid-sized molecules and not go after the blockbuster molecules. "We want to balance our risks and, therefore, we will go in for more number of filings for mid-sized molecules," he elaborated.

The success of the Morepen Laboratories' proposals would largely depend on the corporate debt-restructuring (CDR) plan approved by the banks and financial institutions. However, Mr Suri said that the company could also look at alternate funding from other institutions or strategic investors. "We expect the CDR to be finalised shortly," he added.

More Stories on : Announcements | Pharmaceuticals

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page

Stories in this Section
Morepen filing 6 new drug master files

Draft rules soon on transfer pricing under Cos Act

Kairali makes Rs 6-cr profit

Dabur plans soaps foray — Stays open to buying brands

NTPC expansion project `on course' — Commissions 500-MW unit VII at Ramagundam

Membrane Tech, DuPont tie-up to benefit Chemfab

AP Paper Mills to adopt new tech for high-grade product