21-08-2024 03:58 PM | Source: Accord Fintech
Indoco Remedies climbs on getting USFDA’s final approval for Lofexidine Tablets

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Indoco Remedies is currently trading at Rs. 351.05, up by 15.65 points or 4.67% from its previous closing of Rs. 335.40 on the BSE.

The scrip opened at Rs. 336.55 and has touched a high and low of Rs. 353.95 and Rs. 336.55 respectively. So far 29140 shares were traded on the counter.

The BSE group 'B' stock of face value Rs. 2 has touched a 52 week high of Rs. 416.95 on 01-Jan-2024 and a 52 week low of Rs. 286.50 on 04-Jun-2024.

Last one week high and low of the scrip stood at Rs. 353.95 and Rs. 322.85 respectively. The current market cap of the company is Rs. 3234.21 crore.

The promoters holding in the company stood at 58.75%, while Institutions and Non-Institutions held 20.14% and 21.10% respectively.

Indoco Remedies has received final approval from the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Lofexidine Tablets 0.18 mg to market a generic equivalent of Lucemyra Tablets, 0.18 mg of USWM, LLC. The company 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 (Product) in the USA. This exclusivity will begin to run from the date of the first commercial marketing of the product. 

The company 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 in India. 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 $15.59 million with an expected growth of 38%.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.