Shilpa Medicare secures Europe approval for smoking cessation drug Varenicline
Varenicline is indicated for smoking cessation in adults. It is used for quitting smoking.
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-26 07:12 GMT | Update On 2024-03-21 10:11 GMT
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Karnataka: Shilpa Medicare Limited has announced that the Company 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," the Company stated in a recent BSE filing.
Shilpa Medicare Limited started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
Read also: Shilpa Medicare gets Code J for Pemetrexed Injection
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