European approval for Varenicline:  Shares of Shilpa Medicare were trading 0.18 per cent higher at Rs 438.15 per share in the early trade on Monday, after the company said that the UK healthcare products regulatory agency allowed it to market a Meniere’s syndrome drug.
As of 12:22 pm, shares of Shilpa Medicare were trading 0.18 per cent higher at Rs 438.15 per share.
Shilpa Medicare Limited, based in Raichur, Karnataka, has recently obtained approval from the European regulatory authorities for its Varenicline tablets, 0.5 mg and 1 mg, used in smoking cessation therapy for adults, the company informed exchanges. 

The closure of the decentralised procedure marks a crucial milestone for the company, allowing it to commence commercial supplies after obtaining approval through the national procedure, the company release added.  

Varenicline is a medication specifically indicated for smoking cessation, aiding individuals in their efforts to quit smoking. The approval of these tablets is expected to address the drug shortage issue that arose due to post-production quality problems, ensuring a steady supply of this essential medicine.

Before the decline in sales caused by the shortage, Varenicline had recorded sales of approximately $57 million as of December 2021. This approval not only allows Shilpa Medicare to address the existing shortage but also enables them to provide medication for those seeking to quit smoking.

The approval of Varenicline tablets signifies Shilpa Medicare's goal to provide effective solutions for smoking cessation and improve public health. It also demonstrates their capability to meet stringent quality standards set by regulatory authorities, ensuring the safety and efficacy of their products.