News about "Lupin"

Lupin Receives US FDA EIR for Ankleshwar Manufacturing Facility

Lupin has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Ankleshwar facility following the successful closure of a product-specific pre-approval inspection conducted in March 2026.

Lupin | 28/05/2026 | By News Bureau

Lupin Secures China Approval for Oseltamivir Phosphate Oral Suspension

Lupin receives approval in China for Oseltamivir Phosphate Oral Suspension 6 mg/mL, expanding access to influenza treatment, particularly for pediatric patients.

Lupin | 25/05/2026 | By News Bureau

Lupin Gets US FDA Tentative Approval for Revefenacin Inhalation Solution

Lupin receives tentative US Food and Drug Administration (FDA) approval for Revefenacin Inhalation Solution, a generic version of Yupelri for maintenance treatment of Chronic
Obstructive Pulmonary Disease (COPD).<br />

Lupin | 20/05/2026 | By News Bureau

Lupin Secures FDA Approval for Famotidine Injection USP

Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials.

Lupin | 14/05/2026 | By News Bureau |  104

Lupin Receives US FDA Approval for Glycerol Phenylbutyrate Oral Liquid

Lupin secures US Food and Drug Administration (FDA) approval for Glycerol Phenylbutyrate Oral Liquid (1.1 g/mL), bioequivalent to Ravicti Oral Liquid.

Lupin | 05/05/2026 | By News Bureau

Lupin Subsidiary Settles US Antitrust Case with Humana

Lupin subsidiary Lupin Pharmaceuticals Inc has reached a USD 30 million settlement with Humana in a US antitrust case, resolving claims without any admission of liability.

Lupin | 17/04/2026 | By News Bureau |  107

Lupin Expands Specialty Care Business with VISUfarma Buyout

Lupin Limited has announced the completion of its acquisition of VISUfarma B.V. from GHO Capital Partners LLP, marking a significant step in strengthening its specialty care portfolio and expanding its footprint in Europe.

Lupin | 02/04/2026 | By Darshana

Lupin Gets US FDA Tentative Approval for Pitolisant Tablets

US FDA grants tentative approval to Lupin’s Pitolisant Tablets (4.45 mg, 17.8 mg), bioequivalent to Wakix, for approved indications.

Lupin | 25/03/2026 | By News Bureau

Lupin and Zydus Partner to Co-Market Semaglutide Injection in India

Lupin has secured semi-exclusive rights to co-market Zydus’ Semaglutide injection in India under the brands Semanext and Livarise, while Zydus will continue marketing it under the brand names SEMAGLYNTM, MASHEMATM and ALTERMETM.

Lupin | 18/03/2026 | By News Bureau |  211

Lupin Limited Secures US FDA Approval for Generic Brivaracetam Oral Solution

Lupin has received US FDA approval for its generic brivaracetam oral solution, bioequivalent to Briviact, and has launched the product in the US market targeting partial-onset seizures.

Lupin | 25/02/2026 | By News Bureau |  210