Pharma Major Lupin said received final approval for launching a generic version of Mallinckrodt Inc.’s Roxicodone Tablets in the United States.
The drug is used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, the company said.
Roxicodone Tablets has US sales of USD 344 million per year.
Lupin’s Oxycodone Hydrochloride tablets of 5 mg, 10 mg, 15 mg, 20 mg and 30 mg dosage are the AB rated generic equivalent of Malinckrodt inc.’s Roxicodoneo Tablets.
Lupin focuses on drugs in areas such as cardiovascular, diabetology, asthma, pediatric, CNS, anti-infective and NSAIDs.
It is the largest globally in the Anti-TB segment.
Lupin the sixth largest generics pharmaceutical company by sales globally
The Company is the fifth largestpharmaceutical player in the US by prescriptions and the 2 largest Indian pharmaceutical company by global revenues.
For the financial year ended 31 March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 bilion) and Rs. 25,575 milion (USD 381 million) respectively.