Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Approves Ranbaxy’s Fenofibrate Capsules

By Pharmaceutical Processing | November 6, 2014

Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively, of Lupin Atlantis (Lupin).  Total annual market sales for Fenofibrate Capsules USP, 43 mg and 130 mg were $56 million (IMS – MAT: September 2014).  Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia.  In addition, it is indicated for Severe Hypertriglyceridemia.

“We are pleased to receive approval for these two strengths of Fenofibrate Capsules, which represents a welcome addition to our generic portfolio of products and offer an alternative in strengths and dosage forms for this molecule to patients and healthcare professionals. The product will be manufactured at Ohm Laboratories, in our U.S. facility located in New Brunswick, New Jersey and launched immediately thereafter,” according to Dan Schober, Vice President, Trade Sales.  

Related Articles Read More >

Wyzo
Wyzo high-speed pick-and-place sidebot wins design awards
Purdue University
Purdue University launches institute for advanced manufacturing of pharmaceuticals
Sanofi logo
Sanofi introduces its first digital accelerator 
Cambridge Pharma launches with UK plant in Cambridge Research Park

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards