"Indoco Remedies received final approval of its ANDA (Abbreviated New Drug Application) for Febuxostat tablets 40 mg and 80 mg, which is therapeutically equivalent to the Reference Listed Drug (RLD), viz, Uloric Tablets 40 mg and 80 mg of Takeda Pharmaceuticals USA, Inc," the company said in a filing to the BSE.
Hyperuricemia can cause kidney disease and kidney stones as well.
This is an outcome of the last successful inspection conducted by UK Medicines and Healthcare Products Regulatory Agency (MHRA) from September 16-20 this year, the company said in a regulatory filing.
UK MHRA conducted inspection of the facility during September 16-20 this year.
Indoco said the inspection was successfully conducted without any observations.
Ramco Cements sold 27.24 lakh tonne of cement in the September quarter compared to 24.69 lakh tonne in the same period last year.
US FDA inspected Indico's Goa Unit II from October 7 to October 15. The stock gained over 8 percent in the last three days.
The regulator also said the company was responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
Prabhudas Lilladher recommended hold rating on Indoco Remedies with a target price of Rs 137 in its research report dated July 18, 2019.
The inspection of oral dosages plant at Goa was carried out by the US Food and Drug Administration in January 2019.
Net Sales are expected to increase by 26.2 percent Y-o-Y (up 9.5 percent Q-o-Q) to Rs. 268.2 crore, according to Prabhudas Lilladher.
The company did not disclose the details of the observations made by the regulator but said it will submit its response shortly.
ICICI Direct recommended hold rating on Indoco Remedies with a target price of Rs 195 in its research report dated January 31, 2019.
"The inspection concluded with the company receiving two minor observations, none of which are repeat in nature," Indoco Remedies said in a regulatory filing.
Aditi Kare Panandikar, Managing Director of Indoco Remedies said, "This positive development will now pave the way for approval of our pending ANDAs with consequent boost to revenues from the US market."
Net Sales are expected to decrease by 7.7 percent Y-o-Y (up 20.9 percent Q-o-Q) to Rs. 262.9 crore, according to ICICI Direct.
ICICI Direct recommended hold rating on Indoco Remedies with a target price of Rs 190 in its research report dated June 04, 2018.
KRChoksey is bullish on Indoco Remedies has recommended buy rating on the stock with a target price of Rs 228 in its research report dated May 31, 2018.
Goa plant I manufactures solid dosages, liquid orals and external preparations.
Indoco's Unit-1, located in Goa, is an oral dosage manufacturing plant and the contribution of this unit to overall sales is small.
ICICI Direct recommended hold rating on Indoco Remedies with a target price of Rs 250 in its research report dated November 09, 2017.