Matrix to file 10 drug master files with FDA

The Hyderabad-based Matrix Laboratories Ltd is planning to file 10 drug master files (DMFs) with the United States Food and Drugs Administration by the end of the current fiscal, in addition to 7 DMFs that were filed so far.

Disclosing this at the company's annual general meeting in Hyderabad on Friday, N Prasad, the chief executive officer, said all these were active DMFs.

"Normally DMFs does not mean immediate business. However, at Matrix, we file DMF only when it is backed by firm business contracts. We call them as active DMFs," he stated, adding that the contribution of US exports to the turnover of the company will reach 20 per cent mark during this fiscal as against 8 per cent last year.

The 7 DMFs that the company has filed so far with the FDA include Acyclovir, Alprazolam, Fluconazole, Citalopram, Ciprofloxacin, Modafinil and Amlodipine.

Of these, the company has already been exporting Acyclovir to US, besides many other markets, while commercial shipments of Fluconazole is expected to start during the current fiscal.

Matrix has already received FDA approval for Fluconazole, the generic name for Pfizer's $1 billion anti-fungal drug Diflucan. Its patent in US expires on January 29, 2004.

"Our strategy is to have complementary business with our customers. We are not interested in going for the manufacture of dosage forms. We have enough scope to grow in APIs business. Our product pipeline consists of 25 products for supply to regulated markets before 2008, as and when the patents expire. We want to become a knowledge-based, dependable pharmaceuticals supplier for global healthcare industry," Prasad said.

Matrix's existing international customers include Glaxo Smithkline Beecham, Pfizer, Merck generics, Alpharma, Ivax, Apotex, Lek, Sandoz, Ratiopharm, Hexal and Stada.

Responding to shareholders' questions, Prasad said that the company was moving in line with its objective of achieving 35 per cent growth in topline and bottomline in the current fiscal.

Matrix recorded a net profit of Rs 75 crore (Rs 750 million) on sales of Rs 417 crore (Rs 4,170 million) during last fiscal.

The holding of FIIs in the company touched 11 per cent level at present, compared with that of 2 per cent in March and 8 per cent in June, Prasad said.