Indoco Remedies shares surge over 5% after USFDA approval for opioid drug
Indoco Remedies shares rose 5.53 per cent to Rs 358.60 per share on the BSE in intraday deals on Wednesday after the company announced that it has received final approval from the United States Food and Drugs Administration (USFDA) for its new drug application.
The Mumbai-based pharmaceutical company has received approval from the top US regulator to market Lofexidine Tablets 0.18 mg, a generic equivalent of Lucemyra Tablets 0.18 mg from US pharmaceutical company US WorldMeds.
This medication is indicated for the relief of symptoms associated with acute opioid withdrawal and to facilitate completion of opioid withdrawal treatment.
According to data from IQVIA Health, the product’s sales are approximately $15.59 million, with expected growth of 38 percent.
“Indoco has been granted Competitive Generic Therapy (CGT) designation by the USFDA and, as the first approved generic, qualifies for 180 days of CGT exclusivity for Lofexidine tablets, 0.18 mg in the U.S.,” the company said in an exchange filing.
The exclusivity will begin on the date of the first commercial marketing of the product. Indoco plans to launch the product in the US immediately.
This product is manufactured by Indoco at its manufacturing facility at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
“We are extremely pleased with this development as it strengthens our position in the US market and brings us closer to expanding our reach in the US,” said Aditi Panandikar, Managing Director of Indoco Remedies.
Indoco Remedies has a total market capitalization of Rs 3,227.30 crore. The stock is trading at a price to earnings ratio of 61.44 times with an EPS of Rs 11.46.
The company’s stock price has fallen 10 percent this year, after rising just 6.5 percent in the past year.
At 01:32 PM; the company’s shares were trading 4.59 percent higher at Rs 350.80 per share on the BSE. In comparison, the BSE Sensex was almost flat, down 0.10 percent at 80,719 levels.
Headquartered in Mumbai, Indoco has operations in 55 countries. The company is involved in the manufacturing and marketing of pharmaceutical formulations (finished dosage forms) and active pharmaceutical ingredients (APIs).
First publication: Aug 21, 2024 | 1:39 PM IST