Glenmark Pharma receives US FDA approval

Glenmark Pharmaceuticals Ltd has announced that the Company has received US FDA approval for its state of the art semi-solids (ointments & creams) manufacturing plant at Baddi, Himachal Pradesh. This is the third Glenmark manufacturing plant to have been approved by the US FDA. The Baddi plant recently received GMP approval from MHRA of UK, and from 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.

These regulatory approvals in US and EU markets have opened huge opportunities for Glenmark in the topical range of products. Not many Indian Companies are currently tapping the topical segments in Generic market due to high cost of development which involves Clinical studies in target specific patients. With this, Glenmark envisages the launch of a basket of products in skin care / treatment in US and in EU markets.

Speaking on this development, Mr. Glenn Saldanha, CEO & MD, of the Company, 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 2300 Mn (>US$52Mn) 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. The manufacturing facility at Goa is USFDA approved and produces solid orals, external ointments and capsules, for the regulated markets, while the facility at Nasik produces solid orals, liquid orals, external creams, powders and capsules for the regulated markets. The Nasik facility is approved by WHO-GMP, ANVISA apart from other international approvals. The manufacturing plant at Sau Paulo, Brazil produces solid orals, semi solid and liquid orals and is ANVISA approved, while the facility in Vysoke Myto, Czech Republic produces soild orals and semi-solids and is approved by SUKL, a Czech regulatory authority.