- 22 Aug 2024
- ICICI Securities
INDOCO RECEIVED APPROVAL FROM USFDA, FOR THE COMPANY’S ANDA FOR LOFEXIDINE TABLETS
INDOCO - 244 Change: 0.94 (0.39 %)News: Indoco Remedies received final approval from USFDA, for the Company’s ANDA for Lofexidine Tablets to market a generic equivalent of Lucemyra Tablets of USWM. Indoco has been granted Competitive Generic Therapy (CGT) designation by USFDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for Lofexidine Tablets USP. This exclusivity will begin to run from the date of the first commercial marketing of the Product. Indoco intends to launch the Product immediately in USA. This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa. This product is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment. As per IQVIA Health data, the sales of the product are around USD 15.59 million(Rs 130 crore) with an expected growth of 38%.
Views: This is a niche approval for the company and it is from the Goa facility which is being cleared by the USFDA. However other two units from the Goa plant still remain under scrutiny. The company is still grappling with issues such as slower domestic growth, volatile exports growth and below-par margins. We continue to monitor progress on these fronts.
Impact: Neutral