Lupin has received the United States Food and Drug Administration's nod for manufacturing and marketing Turqoz, a generic equivalent of pregnancy prevention pill Lo/Ovral-28, the latest in a string of USFDA approvals for the Indian pharma company.
The American regulator gave its go-ahead to Lupin's "abbreviated new drug application for Turqoz® (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg, to market a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC,” the company informed the stock exchanges on August 1.
"This product will be manufactured at Lupin’s Pithampur facility in India," the release said.
Norgestrel and Ethinyl Estradiol tablets USP (RLD Lo/Ovral-28) had "an estimated annual sale of USD 34 million in the US", Lupin said.
The announcement, which came shortly before the end of the trading hours, pushed Lupin shares by 0.19 percent. The scrip closed at Rs 987 on the BSE, up 0.17 percent from the previous day.
On July 24, Lupin said the FDA gave tentative approval to its new drug application for Dolutegravir Lamivudine and Tenofovir Alafenamide tablets, used in the the treatment of HIV. A week earlier the American drug regulator approved its chlorpromazine hydrochloride tablets used in treating mental disorders.
While Lupin is yet to declare the June 2023 quarter numbers, it reported a 14 percent on-year jump in net profit at Rs 236 crore in the three-month period ending March 31. The company's sales grew 12.1 percent on year to Rs 4,330 crore during the period.
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