Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, has received closure of Decentralized Procedure for Varenicline Tablets, 0.5 mg and 1 mg. Commercial supplies shall be started after the approval of National Procedure. 

Varenicline is indicated for smoking cessation in adults. It is used for quitting smoking. 

This product had sales of about 57 Million USD as of December 2021 prior to a decline in sales due to drug shortage due to post-production quality issues. This approval will enable Shilpa to make this quality medicine available to adults who intend to quit smoking and fill the drug shortage.