Ways2Capital Reviews : USFDA Approves Supplemental ANDA From Glenmark’s North Carolina Facility

Global pharmaceutical company, Glenmark Pharmaceuticals has announced that the USFDA provided its first supplemental Abbreviated New Drug Application (sANDA) approval for the company’s manufacturing facility in Monroe, North Carolina.

The approval covers Atovaquone and Proguanil Hydrochloride Tablets, 250mg/100mg and 62.5mg/25mg, a generic version of GlaxoSmithKline’s Malarone® (atovaquone and proguanil hydrochloride) Tablets1.

“This approval is an important milestone for our US business, as the Monroe site will expand our portfolio by providing the manufacturing foundation for future product approvals,” said Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals.

The Monroe, North Carolina facility is Glenmark’s first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations. Glenmark has invested more than $100mn into the facility with plans for further expansion in the coming years. At peak capacity, the site is anticipated to produce 300-400mn tablets and capsules, 20-25mn vials and prefilled syringes and 25-30mn ampoules for inhaled formulations. Globally, Glenmark has 16 manufacturing facilities in Europe, India and the US, operating under Good Manufacturing Practices (GMP) to ensure quality and safety.

Glenmark’s business is spread across APIs, and formulations. In Q4FY18, India contributed 27% of its revenue, while US (31%), ROW (13%), Europe (14%), Latin America (6%) and API and others (10%) contributed the remaining. It holds 2.29% market share in the domestic market in Q4FY18. It has eight novel drug candidates in several therapeutic segments. Glenmark has total 16 USFDA approved facilities spread across globe.


Glenmark Pharmaceuticals Ltd is currently trading at Rs597 up by Rs14.7 or 2.52% from its previous closing of Rs582.30 on the BSE.

The scrip opened at Rs586.80 and has touched a high and low of Rs603.35 and Rs585.80 respectively. So far 11,68,093 (NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs16,432.13cr.
 
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