ChemDmart
Chemxpert Database
  • About
    • About
    • Leadership
    • Advisory Board
  • Products
    • ChemProtel - Product Intelligence
    • CompFolio - One Company Profile
    • CompGroupe - Group Company Profile
    • ChemScape - Data Landscape
    • ChemDmart - E-Market Place
    • DataIntel - Data Analytics/Trends
    • DataFeed - Data News/Feed
    • CompShow- Company Showcase
  • Sources
  • Subscription
  • User Guide
  • Contact
  • Book Demo Log In
  1. Home
  2. All News
  3. Lupin Receives Tentative Approval From Us Fda For Oxcarbazepine Er Tablets
News Feed
course image
  • 09 Jun 2025
  • Admin
  • News Article

Lupin Receives Tentative Approval From U.S. FDA For Oxcarbazepine ER Tablets

Overview

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg.  

About the manufacturing

• This product would be manufactured at Lupin’s Nagpur facility in India. 

• Oxcarbazepine ER Tablets, 150 mg, 300 mg, and 600 mg are bioequivalent to Oxtellar XR® ER Tablets, 150 mg, 300 mg, and 600 mg, of Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial-onset seizures in patients 6 years of age and older. 

• Oxcarbazepine ER Tablets (RLD Oxtellar XR®) had estimated annual sales of USD 206 million in the U.S. (IQVIA MAT April 2025). 

About Lupin

• Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. 

• Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. 

• Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. 

• Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. 

• Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Let’s apply Data-Driven Pricing to Your APIs

Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.

Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.

Start using market intelligence today and allow yourself to be in control in the API market.

Check it out today and make more informed sourcing decisions! Learn More!

Categories

image
Product Related Updates
image
Certificates/Accreditation
image
Approval/Launch
image
Clinical Trial Update
image
Licensing/Partnering/Collaboration Deal
image
ODD/BTA/FTA Status
image
Merger/Acquisition
image
Warning/Recalls

Lifescience Intellipedia Pvt. Ltd.

C-89, Sector-65 Noida-U.P. 201301 (India)
Toll-Free: 18004190155
Phone: +91-120-6631301-361
Mobile: +91-9990237670
Email: info@lifescienceintellipedia.com
Email: sales@lifescienceintellipedia.com

USEFUL LINKS

  • Home
  • Privacy Policy
  • Terms & Conditions
  • Terms Of Use
  • Refund Policy
  • Blogs

OUR PRODUCTS

  • ChemProtel - Product Intelligence
  • CompFolio - One Company Profile
  • CompGroupe - Group Company Profile
  • ChemScape - Data Landscape
  • ChemDmart - E-Market Place
  • DataIntel - Data Analytics/Trends
  • DataFeed - Data News/Feed
  • CompShow- Company Showcase

LOCATION

© Copyright Lifescience Intellipedia Pvt. Ltd.. All Rights Reserved

Fill The Form