Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin received an Establishment Inspection Report (EIR) from the U.S. FDA for its Somerset manufacturing facility, with a satisfactory Voluntary Action Indicated (VAI) classification. This outcome reflects the company's commitment to quality and compliance, which is crucial for its operations.
Jul 01 2026 21:55:38
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin received EMA approval for NaMuscla® to expand its pediatric indication to treat non-dystrophic myotonic disorders in children and adolescents. This approval also includes new 62mg and 83mg dosage strengths, in addition to the existing 167mg.
Jul 01 2026 16:47:31
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin Limited received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Enzalutamide Tablets across multiple strengths. This approval allows Lupin to market a generic version of a key oncology drug.
Jun 26 2026 09:37:25
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin launched Azilsartan Medoxomil Tablets, 40mg and 80mg, in the United States. The product is bioequivalent to Edarbi® and received U.S. FDA approval, making Lupin eligible for 180-day generic drug exclusivity.
Jun 17 2026 17:07:33
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin collaborates with LABORATORIOS ERN to launch Luforbec® (beclometasone/formoterol) pMDI in Spain. This expands its global respiratory care portfolio and market presence, leveraging ERN's local expertise and Lupin's manufacturing excellence.
Jun 08 2026 12:19:58
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin Limited announced US FDA approval for its ranibizumab, Ranluspec™ Injection, as an interchangeable biosimilar referencing Lucentis®. This approval is significant as Ranluspec™ is the only interchangeable biosimilar approved in both vials and pre-filled syringes, strengthening Lupin's biosimilar portfolio and market access.
Jun 04 2026 23:06:29
Lupin Ltd - 500257 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Lupin and its partner Natco Pharma received US FDA approval for Eribulin Mesylate Injection, a generic version of a drug with estimated annual sales of $43.7 million. This approval allows the companies to launch a new product for metastatic breast cancer treatment in the US market.
Jun 03 2026 11:02:54
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