Mumbai: Indian drugmaker Lupin said on Tuesday it has received the US Food and Drug Administration’s approval to sell its first oral contraceptive, norethindrone tablets, in the country.
Shipment of norethindrone tablets, a copy-cat version of Watson Pharmaceuticals’ brand Nor-QD, would begin “shortly”, the Indian company said in a statement.
Sales of norethindrone tablet, including that of other generic versions, over the last 12 months stood at about $52 million in the US.
“We look forward to several more approvals and launches in the quarters and years to come,” Nilesh Gupta, group president and executive director, Lupin, said in a statement.
The US oral contraceptives market is valued about $4.5 billion and Lupin has made 26 filings in this category with the drug regulator.
The products would be manufactured at a dedicated unit set up by Lupin in Madhya Pradesh.
On Tuesday, shares of Lupin, which have gained about 21% in value over the last six months, ended up 2.04% at Rs 483.55 on Tuesday in a firm Mumbai market.