 "Pharma major Lupin gets USFDA approval for its generic antibiotic")
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Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets of strengths 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, Lupin said in a regulatory filing.
This product will be manufactured at Lupin's Pithampur facility in India, it added.
Doxycycline Hyclate Delayed-Release tablets had estimated annual sales of USD 9 million in the US, the company said citing IQVIA MAT June 2023 data.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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