Unichem Laboratories Ltd on Friday announced that the United States Food and Drug Administration (USFDA) approved its Ranolazine Extended-Release tablets used in cases of chronic angina.

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In a filing to the stock exchanges, the leading manufacturer of active pharmaceutical ingredients said that it received approval for the Abbreviated New Drug Application (ANDA) of Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg from USFDA.

The federal agency has given a go-ahead to Unichem Laboratories for marketing a generic version of Gilead Sciences’ Ranexa tablets 500 mg and 1,000 mg. Gilead Sciences is a biopharmaceutical company based in California, US.

Ranolazine Extended-Release Tablets are prescribed for the treatment of chronic angina, Unichem Labs said in a release. The company said that the product will be commercialised from its manufacturing facility in Goa.

Angina is a symptom of coronary artery disease and it could be a result of reduced blood flow to the heart.

The Mumbai-based company was reportedly in discussions with the Slovenian pharmaceutical company Krka, d.d., Novo Mesto for the acquisition of its (Unichem) promoter’s stake, in January 2023.

Last year, on October 14, the pharma company had received ANDA Nod from USFDA for Phenytoin Sodium Capsules used to control certain type of seizures.

Prior to this, in August 2022, the company had received permission from US regulator to market Carbamazepine Tablets, an anticonvulsant drug, in the American market. The drug is used for treatment of trigeminal neuralgia pain, an anticonvulsant drug, in the American market.

Unichem Laboratories' net loss widened in the December quarter to Rs 63.9 crore from Rs 14.1 crore last year. Sales declined nearly 3 percent year-on-year.

Shares of Unichem Laboratories are trading 4 percent lower at Rs 281.25.

(Edited by : Rukmani Krishna)