Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
The company has already filed four Drug Master Files with the US Food and Drugs Administration, it said.
A DMF is a submission to the FDA of information concerning the chemistry, manufacturing and controls of a drug product or component of a drug product.
An Alembic statement to the BSE said clearances were likely to take at least two years.
Alembic said it was in the process of identifying US-based drug makers through which it can sell its bulk drugs.