Glenmark’s Goa plant gets US FDA approval

Glenmark’s Goa plant gets US FDA approval

EPP News Bureau – Mumbai

Glenmark Pharmaceuticals announced that it has received United Stated\s Food and Drug Administration (USFDA) approval for its solid dosage plant in Goa. The plant 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-Therapeutics Products Directorate, Canada (TPD) and Medicine Control Council, South Africa (MCC).

Glenn Saldanha, Managing Director and CEO of Glenmark said, “These approvals are significant for Glenmark’s plans to accelerate our generics push into the regulated markets. We were able to get these approvals in a record time of a little over one year from commissioning.

Additionally, five US Abbreviated New Drug Application (ANDA) filings from the facility triggered the USFDA inspection and we hope to receive approval for marketing some of these products shortly.”

Glenmark has filed seven 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 and Konec, 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 percent of the US market.

The company also entered an exclusive license agreement with InvaGen for marketing its anti-hypertensive agent, Fosinopril Sodium oral tablets (Monopril), for the US market. Glenmark had purchased two ANDAs from Clonmel Healthcare in 2005 and signed a collaboration agreement with another Indian company, Shasun Chemicals and Drugs, 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.