US FDA approves Glenmark Pharmaceuticals Baddi semi-solids plant

Glenmark Pharmaceuticals Ltd says the US FDA has approved its new semi-solids plant at Baddi in Himachal Pradesh for manufacturing ointments and creams. This is the company's third manufacturing facility to have been approved by the US FDA.

The Baddi plant had 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 global markets to launch a basket of products in skin care and treatment in US and in EU markets.

According to the company, these regulatory approvals in US and EU markets have opened huge opportunities for it in the topical range of products, an area that not many Indian companies are currently tapping because of the high cost of development involving clinical studies in target-specific patients.

"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." says Glenn Saldanha, chief executive officer and managing director, Glenmark Pharmaceuticals.

Glenmark's facility at Baddi is fully commissioned and produces Rs230 crore (approximately $52 million) worth of products for the Indian markets and has produced batches for filing in the US and Europe. Glenmark expects the Baddi facility to break-even in its first two years of operation.

Glenmark has its formulations manufacturing facilities in Goa and Nasik in western India  apart Baddi and overseas in Sao Paulo in Brazil and in Vysoke Myto in the  Czech Republic. The Goa facility is also 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, and Brazil's ANVISA apart from other international approvals. The manufacturing plant at Sau Paulo produces solid orals, semi solid and liquid orals, while the facility in Vysoke Myto produces soild orals and semi-solids and is approved by the Czech regulatory authority SUKL.