Indoco Remedies stock surged up to 5.53 per cent at Rs 358.60 per share on the BSE in Wednesday’s intraday deals. This came after the company disclosed that it has received a final approval from the United States Food and Drugs Administration (USFDA) for its new drug application.

The Mumbai-based pharmaceutical received the top US regulator’s nod to market Lofexidine Tablets 0.18 mg, a generic equivalent of Lucemyra Tablets, 0.18 mg of the US-based drugmaker US WorldMeds.

This drug is indicated for mitigation of symptoms associated with acute withdrawal from opioids and for facilitation of the completion of opioid discontinuation treatment.

According to IQVIA Health data, the sales of the product are around $15.59 million with an expected growth of 38 per cent.

“Indoco has been granted a competitive generic therapy (CGT) designation by the USFDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for Lofexidine Tablets, 0.18 mg in the USA,” the company said in an exchange filing.

The exclusivity will begin to run from the date of the first commercial marketing of the product. Indoco intends to launch the product immediately in the USA.

This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.

“We are extremely pleased with this development as this strengthens our position in the US market, driving us closer to expanding our reach in the US,” said Aditi Panandikar, Managing Director, Indoco Remedies.

Indoco Remedies has a total market capitalisation of Rs 3,227.30 crore. Its shares are trading at a price to earnings multiple of 61.44 times with an earning per share of Rs 11.46.

The share price of the company has dropped 10 per cent year to date, while it has gained only 6.5 per cent in the last one year.

At 01:32 PM; the stock of the company was trading 4.59 per cent higher at Rs 350.80 per share on the BSE. By comparison, the BSE Sensex was nearly flat, down 0.10 per cent 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).