Glenmark receives ANDA approval for Fingolimod Capsules

▴ Glenmark receives ANDA approval for Fingolimod Capsules
Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company in Generics, Specialty and OTC business

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya1 Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.

According to IQVIATM sales data for the 12 month period ending April 2020, the Gilenya Capsules, 0.5 mg market2 achieved annual sales of approximately $2.1 billion.Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

The stock hit an intraday high of Rs. 409.9 and intraday low of 398.7. The net turnover during the day was Rs. 129019870.

Recently, Glenmark Pharmaceuticals Inc., USA (Glenmark) was also, granted final approval by the United States Food & Drug Administration (U.S. FDA) for Chlorzoxazone Tablets USP,375 mg and 750 mg. This marks Glenmark’s first ANDA approval out of their new North American manufacturing facility based in Monroe, North Carolina.
According to IQVIATM,1sales data for the 12 month period ending March 2020, the Chlorzoxazone Tablets, 375 mg and 750 mg market2 achieved annual sales of approximately $20.9 million. Glenmark’s current portfolio consists of 163 products authorized for distribution in the U.S.marketplace and 45 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and
accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue 

Tags : #Glenmark #Fingolimod #AndaApproval #USFDA #Generics #SpecialityMedicine #PharmaOTC #PharmaNews #PharmaUpdate

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