FDA grants supplemental ANDA approval for Glenmark’s Monroe unit
Category: #health  By Saipriya Iyer  Date: 2018-06-20
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FDA grants supplemental ANDA approval for Glenmark’s Monroe unit

Glenmark Pharmaceuticals, a pharma firm based in Mumbai, has received a green signal from U.S. FDA for its drug manufactured at Monroe at North Carolina facility. Incidentally, the approval has been granted for the production of atovaquone and proguanil hydrochloride tablets. These drugs are a generic version of Malarone by GlaxoSmithKline, used for treating malaria, claim sources.

If reports are to be believed, this is the first time that Glenmark has received a supplemental Abbreviated New Drug Application (ANDA) approval from the FDA. Robert Matsuk, President, North America & Global API, Glenmark Pharmaceuticals Ltd, was quoted stating that the approval demonstrates an important achievement for the company’s U.S. business. He further claimed that that the Monroe drug manufacturing site will help Glenmark expand its product line, thereby providing a base for the firm’s future drug approvals.

Sources cite that the Monroe-based unit is the firm’s first drug manufacturing site across the U.S. and had been set up to produce myriad fixed dose drug formulations. For the record, the Indian based pharma company has made investments worth over USD 100 million in the drug manufacturing factory and is planning to expand over the next few years.

FiercePharma has recorded Robert Mastuk’s statement that defends the firm’s investment in Monroe facility and claims that the unit will generate high-quality jobs for the Monroe community, where the company is committed to long-term business expansion.

The North Carolina establishment of Glenmark is expected to manufacture approximately 300-400 million tablets & capsules. The company is also projected to produce 20-25 million vials, pre-filled medical syringes, and 25-30 million ampoules for inhaled formulations.

Authentic reports have claimed that the Mumbai-based drug company has 16 medicine production units across Europe, U.S., and India. The firm has 8 new drug candidates across various therapeutic sectors. Reportedly, during the fourth quarter of FY18, the Indian unit of Glenmark accounted for 27% of the firm’s overall revenue, while the U.S. division contributed approximately 31% towards the total revenue.



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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