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News about "Lupin"
US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated
The US Food and Drug Administration (FDA) has concluded its inspection of Lupin’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.
Lupin | 04/10/2025 | By Dineshwori
Lupin Launches Liraglutide Injection in US
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use pre-filled pen is bioequivalent to Victoza injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk Inc.
Lupin | 04/10/2025 | By Dineshwori
Lupin Launches Generic Xarelto Rivaroxaban Oral Suspension in US
Global pharma major Lupin has announced the launch of Rivaroxaban for Oral Suspension, 1 mg/mL, in the United States.
Lupin | 03/10/2025 | By Dineshwori
Lupin Receives Approval from US FDA for Rivaroxaban for Oral Suspension
Lupin’s Rivaroxaban will be manufactured at the company’s Chhatrapati Sambhajinagar facility.
Lupin | 01/10/2025 | By Dineshwori
Lupin Acquires VISUfarma, Strengthens Global Specialty Ophthalmology Business
By integrating VISUfarma’s established commercial operations, Lupin aims to tap into the attractive ophthalmology market.
Lupin | 30/09/2025 | By Dineshwori
Lupin Receives Tentative Approval from US FDA for its HIV treatment tablets
Lupin has received tentative US FDA approval for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets to treat HIV, bioequivalent to Gilead’s Biktarvy, for adults and paediatric patients over 25 kg.
Lupin | 25/09/2025 | By Dineshwori
Lupin Secures US FDA Approval for Lenalidomide Capsules
The approved Lenalidomide Capsules, bioequivalent to Revlimid by Bristol-Myers Squibb, will be produced at Lupin’s Pithampur site in India.
Lupin | 17/09/2025 | By Dineshwori
Lupin's Aurangabad Facility Gets Two Observations After US FDA Inspection
The United States Food and Drug Administration (US FDA) has completed a product-specific pre-approval inspection at Lupin’s Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility, issuing two observations.
Lupin | 06/09/2025 | By Dineshwori | 101
Lupin Secures US FDA Approval for Risperidone Long-Acting Injectable
Lupin has received US FDA approval for its Risperidone extended-release injectable suspension, marking the first product from its Nanomi long-acting injectables platform with 180-day CGT exclusivity.
Lupin | 03/09/2025 | By Mrinmoy Dey
Lupin launches Glucagon for Injection USP, 1 mg/Vial in US Market
Lupin has launched its Glucagon for Injection USP, 1mg/vial emergency kit in the US, a bioequivalent to Eli Lilly’s product, for treating severe hypoglycemia and aiding certain radiologic procedures.
Lupin | 12/08/2025 | By Mrinmoy Dey
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