Lupin’s biosimilar Armlupeg gains U.S.FDA approval
The product will be manufactured at Lupin’s biotech facility in Pune, which was inspected by the U.S. FDA prior to approval
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United States Food and Drug Administration (U.S. FDA)
Lupin receives US FDA approval for generic Tolvaptan Tablets
Company secures 180-day marketing exclusivity as first-to-file applicant for bioequivalent to Jynarque
Lupin receives U.S. FDA approval for generic Ipratropium Bromide nasal spray
Approval allows marketing of generic equivalent of Atrovent Nasal Spray in the U.S.
Lupin and Natco secure US FDA approval for generic Bosentan tablets for oral suspension
Natco receives first-to-file exclusivity for Bosentan Tablets for Oral Suspension, 32 mg, in the US market
Lupin secures FDA approval for generic Emtricitabine and Tenofovir Alafenamide tablets
Lupin to launch generic version of Descovy with 180-day exclusivity, targeting HIV treatment market