The Vadodara-based Alembic Ltd is planning to expand its bulks drugs business to the highly regulated US market by joining hands with few US-based formulation majors.

As a first step in this direction, the company has filed four Drug Master Files (DMF) with the US FDA and it is planning to file more such applications with the US-based drugs authorities for the next two-three years.

The Company is also in the process of filing DMFs with the health authorities in various other regulatory markets for many potential drugs that will go off patent in the developed countries during the next four to five years. The Company is also in the process of identifying US-based drug makers, through which it would be able to sell its bulk drugs in US.

Alembic is expecting sales realization from its proposed US operations only after two years, as the approval process takes minimum two years for clearance. Besides US, the Company is also looking at UK and Latin American market for expanding its bulk drugs business and the Company is also in the process of filing DMFs in these countries.