Glenmark Pharmaceuticals Ltd has received approval from MHRA of UK for its state of the art semi-solids (ointments and creams) manufacturing plant at Baddi, Himachal Pradesh. This is the third of the company's manufacturing plants to have been approved for GMP by the UK regulatory agency MHRA.
This will enable the company's foray into supply of creams and ointments in Europe soon. The Baddi plant had already received GMP approval from TPD, Canada, and is well on course to receiving US FDA approval in the near future, which would enable the company to enter the niche segment of semi-solid dosages in most of the regulated markets of the world.
Speaking, on this development Glenn Saldanha, CEO and MD, of the company said, "The approval from UK MHRA will provide further impetus to our current expansion efforts in the European region. Our plant at Baddi has been built to the highest international standards and has been producing batches for filing in Europe and the US. Glenmark has been constantly upgrading its manufacturing facilities to efficiently meet the anticipated demands of the global markets and we look forward to the US FDA approval for Baddi as the next milestone."
The company's facility at Baddi is fully commissioned with more than Rs 230 crore worth of production coming from this facility. Baddi presently supplies the company's Indian requirements and has produced batches for filing in the US and Europe. The company hopes that the Baddi facility will break-even in its first two years of operation.
The company 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 Goa is US FDA 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. Its 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 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.