Glenmark’s US team has witnessed tremendous amount of growth in the past two years, and its latest success is the first ANDA filed and approved out of the Monroe facility. The drug called ‘Chlorzoxazone’ is a centrally acting skeletal muscle relaxant for the relief of discomfort associated with acute, painful musculoskeletal conditions. This is a major milestone for the Monroe team and Glenmark as a whole.
The approval came in within a record span of 11 months, which the team asserts is an ‘excellent’ development. This is significant because manufacturing products in the US allows for some additional opportunities, such as government contracts. Hearty congratulations to all the teams involved, including Regulatory [IN-RA and US-RA], Quality [Monroe/Mahwah], Manufacturing [Monroe], Demand Planning/Supply Chain, Commercial Team [including the Sales Team], Method Validation Team [Monroe], and Finance/Gov’t Pricing.
As part of Glenmark’s global business strategy the Monroe facility was built to be the first US based manufacturing faculty with a focus on Complex Generics. In the last two years the site has developed a pipeline which includes 7 approved products, 4 filed products and 6 products in the development phase, awaiting filing. The facility is registered with the United States Food and Drug Administration and has completed multiple successful audits.