The USFDA nod will mark the commercialisation of Glenmark’s Monroe plant | Photo: Reuters
Glenmark Pharmaceuticals' maiden US manufacturing site in Monroe, North Carolina received its first product approval from the US drug regulator -- an anti-malarial drug that enjoys a market size of around $40 million in the US. Having a manufacturing footprint in the US, is part of the company's game plan to mitigate regulatory risk.
The product, innovated by GlaxoSmithKline, is already manufactured by Glenmark in India. US Food and Drug Administration (USFDA) is a supplemental approval for Atovaquone and Proguanil Hydrochloride tablets or generic Malarone. People from the US visiting emerging countries use the drug as a preventive against malaria.
This would mark the commercialisation of the Monroe plant, which has a capacity to produce 300-400 mn tablets and capsules, 20-25 mn vials and pre-filled syringes and 25-30 mn ampoules for inhaled formulations at peak capacity. Glenmark has already invested $100mn in that facility, its highest overseas investment on a manufacturing site.
Robert Matsuk, President, North America and Global API, Glenmark said, "This approval is an important milestone for our US business, as the Monroe, NC site will expand our portfolio by providing the manufacturing foundation for future product approvals."
The company plans to make niche products like pre-filled syringes, injectables etc in the Monroe facility. "Having a facility in US not only mitigates regulatory risks in case an Indian plant comes under the FDA scanner, it also enables the company to make hi-tech products. Talent and technology to manufacture niche and speciality products both are available in the US," said a source.
This is Glenmark's fourth overseas manufacturing site after Czech Republic, Argentina and Switzerland (where it has a small biologics facility).