Glenmark gets USFDA approval for Baddi plant

Glenmark Pharmaceuticals announced that the company has received approval from the Food and Drug Administration ( FDA) in the United States for its semi-solids (ointments & creams) manufacturing plant at Baddi, Himachal Pradesh.

This is the third Glenmark manufacturing plant to have been approved by the American regulator.

The Baddi plant recently received GMP approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and from the Therapeutic Products Directorate ( TPD), Canada.

The US FDA approval will now enable Glenmark to enter the niche segment of semi-solid dosages in most of the regulated markets of the world.

Glenn Saldanha, CEO & MD, Glenmark, said: "The current GMP accreditation by US FDA for Baddi site is a significant milestone for Glenmark, since other plants of the company at Ankleshwar and Goa are already approved by these agencies, reflecting international standards of quality system at Glenmark."

Glenmark's facility at Baddi is fully commissioned with more than Rs 230 crore worth of production coming from this facility.

Baddi presently supplies Glenmark's Indian requirements and has produced batches for filing in the US and Europe.

The company expects the Baddi facility to break-even in its first two years of operation.

Glenmark has its formulations manufacturing facilities in Goa, Nasik, and Baddi in India, in Sao Paulo, Brazil and in Vysoke Myto, Czech Republic.