Technical
Channels

Drug Discovery

Drug Development

Drug Manufacturing

Drug Delivery

Clinical Trials

Regulatory and Legal

Alliances and Mergers

QA/QC and Compliance

Pharmaceutical Processing and Packaging

Change text size [+] [-]

CIP-Isotretinoin to be Distributed in the US

Monday, September 01, 2008
 Email This |  Printer Friendly

Cipher has granted Ranbaxy Pharmaceuticals Inc. (RPI) the exclusive right to market, sell and distribute CIP-Isotretinoin in the US. CIP-Isotretinoin is a patented formulation of isotretinoin, which is used in the treatment of severe nodular acne. The product received approvable letters from the US FDA in May 2006 and April 2007 in which the FDA requested that Cipher provide additional clinical safety data. Cipher is currently discussing with the FDA's division of dermatology and dental products on the appropriate design of a safety study.

Under the terms of the agreement, Cipher has received an initial upfront payment of $1 million. The agreement includes additional pre- and postcommercialization payments of up to $23 million, which is based upon the achievement of certain targets


Share this:   Del.icio.us | 
Ask the Expert

What technologies and/or practices can Asian pharma manufacturers adopt today, to ensure quality in their products?

Digital Edition



Singapore's Preclinical R&D industry should differentiate itself in Asia by competing on quality rather than on price.
Yes
No
View results


ABOUT PHARMA ASIA | FREE SUBSCRIPTION | CONTACT US

© 2010 Ten Alps Communications Asia. All rights reserved.
Use of this Web site is subjected to its Terms and Conditions of Use. View our Privacy Policy