Sun Pharmaceutical Industries
has announced that one of its subsidiary has launched colesevelam hydrochloride 625mg tablet. This is an authorized generic version of Welchol which is manufactured by Daiichi Sankyo.
The launch is pursuant to a distribution and supply agreement between Sun Pharma’s wholly owned subsidiary and Daiichi Sankyo Inc.
Daiichi Sankyo has granted Sun Pharma exclusive rights to distribute these tablets in the US market for a pre-determined period. Welchol recorded US sales of ~$520mn for the 12-month period ending March 2018.
The authorized generics are the prescription drugs which are produced by brand companies but marketed as a generic drug by other companies, mainly the generic companies. So this launch has nothing to do with Halol plant approval.