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

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

The Role of Genetic Profiles in Alzheimer’s Therapy: APOE4 and Treatment ResponsesMay 08, 2024
Assessing Covishield Safety: Indian Research Offers Reassurance Amidst Rare Side Effect DiscussionsMay 08, 2024
Quadria Capital Invests $102 Million in NephroPlus to Boost Dialysis Services Across AsiaMay 08, 2024
Reducing Stigma, One Story at a Time: Media's Role in Mental HealthMay 07, 2024
When Your Body Makes Beer: Exploring the Curious Case of Auto-Brewery SyndromeMay 07, 2024
Hair Today, Gone Tomorrow: Why Guys Go Bald Before Marriage May 07, 2024
Menopausal Transitions and Mental Health: UCL Study Highlights Increased Depression RiskMay 07, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Harnessing AI for Early Alzheimer's Disease Diagnosis: IIT Indore's BreakthroughMay 06, 2024
Aurobindo Pharma's Bhiwadi Facility Under FDA Scrutiny: Understanding the ObservationsMay 06, 2024
Exploring the Role of Mediator Protein Complex in Cell Division: Implications for Disease ManagementMay 06, 2024
Akshay Tritiya Parna Mahotsav is to be held in the cityMay 04, 2024
Bharti Singh's Battle with Gallstones: Symptoms, Precautions, and Natural RemediesMay 04, 2024
Empowering Women's Health: New Mammogram GuidelinesMay 04, 2024
Rising Temperatures, Rising Risks: Addressing the Challenges of Heat StressMay 04, 2024
Gynoveda, India's First Ayurveda Fertility Company, Expands Reach with New Clinic in Pune, Set to Open 100 Clinics Across India by 2027May 03, 2024
Aptus Value Housing Finance India Limited, a leading Housing Finance Company has declared its financial results for the year ended March 31, 2024. FY 24 ResultsMay 03, 2024
TIPS FOR PREGNANCY CARE DURING SUMMERMay 03, 2024
The deadly intersection: TB and tobacco smoking co-epidemics in Indonesia Dr TARA SINGH BAM – CNSMay 03, 2024