Indoco secures USFDA nod for Succinylcholine Chloride injection
Indoco Remedies announced receipt of approval from United States Food and Drug Administration (USFDA) of its abbreviated new drug application (ANDA) for Succinylcholine Chloride injection USP multi‐dose vial.
The product is therapeutically equivalent to the reference listed drug (RLD) Quelicin Injection of Hospira and is indicated as an adjunct to general anaesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
US market size of Succinylcholine Chloride injection is of US$ 72 million (6 million vials), as per IMS data for the year ending March 2020. It is also being used for some patients infected with Coronavirus (COVID‐19).
Commenting on this positive development, Aditi Kare Panandikar, Managing Director of Indoco Remedies stated that the receipt of USFDA approval, in a record time of just four months from the date of filing ANDA, is very encouraging for the company. Adding to this, she said that it has brought an enormous opportunity to the company for serving patients in these trying times.
Indoco Remedies Limited primarily manufactures and markets formulations and active pharmaceutical ingredients (APIs).
On Tuesday, the stock of the company closed at Rs 207.50, down by 1.12 per cent or Rs 2.35 per share. The 52-week high is recorded at Rs 285 and the 52-week low is Rs 133.10 on BSE.