Glenmark Pharmaceuticals Ltd. has received US FDA approval for its solid dosage plant in Goa that manufactures formulations for the international regulated markets. In addition to that, the plant also has the distinction of obtaining CGMP approvals by two other international regulatory bodies, viz. Therapeutics Products Directorate, Canada [TPD] and Medicine Control Council, South Africa [MCC].
Glenn Saldanha, Managing Director & CEO, Glenmark said, "These approvals are significant for Glenmark's plans to accelerate our generics push into the regulated markets. Additionally, five US ANDA filings from the facility triggered the US FDA inspection and we hope to receive approval for marketing some of these products shortly."
Glenmark has filed 7 ANDAs to date from this facility and has plans to file 13 more this financial year. In addition, the Company signed two partnership agreements with US based companies, Interpharm Inc. and Konec Inc., for marketing their generic products Naproxen and Nitroglycerin in the US. Glenmark has commenced marketing these generic products through its front-end in the US market and has already locked-in and is supplying contracts amounting to a market share in excess of 15% of the US market.
The Company also entered an exclusive license agreement with InvaGen Inc. for marketing its anti-hypertensive agent, Fosinopril Sodium oral tablets [Monopril], for the US market. Glenmark had purchased two ANDAs from Clonmel Healthcare Ltd. in FY 2005 and had signed a collaboration agreement with another Indian company, Shasun Chemicals and Drugs Ltd., for the joint development and marketing of 13 generic products in the US market. The Company also expects to have at least five products on the market before the end of this financial year.