Glenmark recieves MHRA approval for plant in Himachal Pradesh

Glenmark Pharmaceuticals Limited, one of India’s leading research-led, integrated pharmaceutical companies, has received approval from MHRA of UK for its state of the art semi-solids (ointments & creams) manufacturing plant at Baddi, Himachal Pradesh.

This is the 3rd of Glenmark’s manufacturing plants to have been approved for GMP by the UK regulatory agency – MHRA. This will enable Glenmark’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 USFDA approval in the near future, which would enable Glenmark to enter the niche segment of semi-solid dosages in most of the regulated markets of the world.

Speaking on this development, Mr. Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals Ltd., said, “The approval from MHRA, UK 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.”

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 hopes that the Baddi facility will 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.

About Glenmark:

Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company is a leader in India in the discovery of new molecules. Glenmark has 11 lead molecules at various stages of development in NCE & NBE research. Three of the leads are in Phase II whereas eight other leads are into the pre-clinical and discovery stages in the broad areas of inflammation, metabolic disorders and oncology. The Company has generic formulation and API business interests in over 85 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT, Diabetes and Oncology. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, is undergoing Phase II clinical trials in Europe.

Jagmeet Y. Ghuman