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

Immuneel Therapeutics and THSTI Announce Strategic Partnership to Advance CAR-T Cell Therapy and Lentiviral Vector Manufacturing July 28, 2026
Differential Diagnosis of Acute Abdomen: Differentiating Surgical Emergencies from Gastrointestinal MimicsJuly 28, 2026
Management of Rheumatic Heart Disease in Developing Nations: Secondary Prophylaxis and Valve InterventionsJuly 28, 2026
Hormonal Imbalance in Women: Understanding the Causes, Recognising the Symptoms, and Finding the Right TreatmentJuly 28, 2026
Why Regular Health Screening Matters: A Complete Guide for IndiansJuly 28, 2026
Galderma introduces Sculptra® in India, ushering in a new era of regenerative aestheticsJuly 27, 2026
Artificial Intelligence in Diagnostic Imaging: Enhancing Radiologist Precision and Reducing Human ErrorJuly 27, 2026
Transitioning from Acute Care to Urgent Care Centers: Optimizing Healthcare Facility InfrastructureJuly 27, 2026
Ahead of World Head & Neck Cancer Day, HNCII Launches “Delay is the Real Killer” Cancer Awareness CampaignJuly 25, 2026
Ahead of World Head & Neck Cancer Day, HNCII Launches “Delay is the Real Killer” Cancer Awareness CampaignJuly 25, 2026
Menopause Symptoms Explained: What Every Indian Woman Should KnowJuly 25, 2026
Sleep Deprivation and Its Hidden Impact on Your Health: What Every Indian Should KnowJuly 25, 2026
Air Pollution and Health Effects: What Every Indian Must KnowJuly 25, 2026
NABH Accreditation Explained: What It Means for Indian Hospitals and PatientsJuly 25, 2026
Hypertension in Young Indians: Causes and Early InterventionJuly 24, 2026
How Stress Damages Your Heart: The Mind-Body ConnectionJuly 24, 2026
Living with Arthritis in India: Pain Management and Lifestyle TipsJuly 23, 2026
Iron Deficiency vs B12 Deficiency: Spotting the Difference in IndiansJuly 23, 2026
The ePlane Company and Apollo Hospitals Join Forces to Bring India's Golden Hour Within ReachJuly 23, 2026
Importance of Women's Health Screening: A Comprehensive Guide to Preventive CareJuly 23, 2026