The company has received final approval from the United States Food and Drug Administration (USFDA) to market its Norgestimate and Ethinyl Estradiol tablets USP, 0.25 mg/0.035 mg, Lupin said in a filing to BSE.
The company's product is a generic version of Janssen Pharmaceuticals Inc's Ortho-Cyclen 28 tablets, it added.
"The approved product will be manufactured at Lupin's Pithampur facility," the company said.
Ortho-Cyclen tablets had US sales of USD 178.2 million as per IMS MAT June 2016 data, it added.
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