Indian multinational pharmaceutical company based in Mumbai, primarily manufacturing generic drugs across pediatrics, cardiovascular, anti-infectives, diabetology, asthma, and anti-tuberculosis therapeutic areas.
Clinical Trials
42
11 active
Approvals
118
Total approvals
Agencies
5
Regulatory bodies
Founded
1968
Active, not recruiting
2
4.8%
Completed
16
38.1%
Enrolling By Invitation
1
2.4%
Not yet recruiting
8
19.1%
Recruiting
12
28.6%
Unknown
2
4.8%
Withdrawn
1
2.4%
- Lupin expects biosimilar turnover of close to $500 million over the next five years, anchored by its recently approved pegfilgrastim biosimilar and upcoming ranibizumab launches. - The company has invested about ₹500 crore in biosimilar manufacturing capacity and plans to raise total investment to roughly ₹700 crore. - Lupin has begun raising external funding for Kaveri Therapeutics, its oncology-focused spin-off housing two specialised oncology programmes, while intending to remain majority shareholder. - Biosimilars of nivolumab, dinutuzumab and pertuzumab are planned for India, alongside existing etanercept biosimilar sales in Europe and Japan through partnerships.
- Lupin has secured approval to manufacture and market its pegfilgrastim biosimilar in India, with production planned at its Nagpur facility in Maharashtra. - Pegfilgrastim is an onco-supportive therapy that helps the body produce neutrophils after chemotherapy to reduce the risk of serious infections and fever. - Lupin's Armlupeg is already approved in the US, where commercial rights are out-licensed to Valorum Biologics, while Biocon and Amneal also market US pegfilgrastim biosimilars.
- Glenmark Pharmaceuticals received U.S. FDA approval for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray (50 mcg/spray), expanding its respiratory portfolio in the U.S. market. - The product is bioequivalent and therapeutically equivalent to Flonase Nasal Spray, the reference listed drug marketed by Haleon US Holdings LLC. - According to IQVIA data for the 12 months ended June 2026, the Flonase Nasal Spray market recorded approximately US$295.2 million in annual sales. - The approval follows Glenmark's marketing nod for the OTC version of the drug in March, positioning fluticasone as a key U.S. sales driver.
- Lupin Limited has spun out its two clinical-stage oncology programs, LNP7457 (PRMT5 inhibitor) and LNP8701 (SOS1 inhibitor), into U.S.-based Kaveri Therapeutics Inc. - In exchange for exclusive perpetual global licensing rights, Lupin Inc. acquired an 82.2% equity stake in Kaveri, with the transaction valued at $1.6 million. - Both assets have demonstrated encouraging early clinical data at ASCO meetings, with Phase 1b trials planned for each program. - Kaveri will operate independently under CEO Kristi Jones and CMO Dr. Robert Pierce, seeking external capital to fund further global clinical development.
- The FDA has classified a voluntary recall of over 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1% as Class II, the second-highest risk level. - Lupin Limited initiated the recall on June 4 after a single market complaint from distributor Hilco Vision reported foreign particulate matter in the product. - The foreign substance could potentially cause inflammatory responses, mechanical irritation, corneal injury, and secondary ocular inflammation, according to a Health Hazard Assessment. - Affected bottles span 5 mL, 10 mL, and 15 mL sizes with expiration dates ranging from July 2026 through March 2028, and patients are advised to consult their prescribing physician before discontinuing use.
- The European Medicines Agency approved two new pediatric dosage strengths (62 mg and 83 mg) of Lupin's orphan drug Namuscla for children with non-dystrophic myotonia. - The expanded indication now covers children aged 6–11 years weighing at least 20 kg, adolescents aged 12–17 years, and adults across Europe. - Namuscla remains the first and only licensed product for non-dystrophic myotonia in Europe, reinforcing Lupin's competitive moat in the orphan drug space. - The approval is expected to increase Lupin's addressable European market by 10–15% and strengthen its high-margin specialty pharmaceutical portfolio.
- Lupin's investigational oral drug LNP8701, a SOS1 inhibitor targeting RAS activation, demonstrated favorable safety and tolerability in a Phase 1 study of 20 stage IV cancer patients. - The multicenter trial showed that LNP8701 was well tolerated across all tested dosing levels, with five patients achieving stable disease and one patient showing partial response. - Two patients completed 12 cycles of treatment and one patient completed 14 cycles, all with stable disease, indicating potential for sustained therapeutic benefit in difficult-to-treat cancers.
- Lupin Manufacturing Solutions announced a strategic expansion of its Dabhasa manufacturing facility in India to enhance peptide building-blocks platform and CRDMO capabilities. - The expansion includes a new block with dedicated peptide manufacturing capacity across two additional specialized units to support complex therapeutics development. - The facility upgrades will enable advanced development and flexible manufacturing to meet global demand for complex pharmaceutical solutions including peptides and biologic ADCs. - The expansion reinforces LMS's capability to consistently supply high-quality peptide building blocks, including protected amino acids, supporting the global peptide ecosystem.
- Lupin has settled a patent infringement dispute with Astellas Pharma for $90 million, allowing continued sales of generic Mirabegron in the U.S. market. - The settlement includes a $75 million prepaid option payment and per-unit license fees through September 2027, resolving litigation that began after Lupin's 2024 FDA approval. - Mirabegron holds approximately 26-27.6% of the overactive bladder treatment market, which was valued at $3.63 billion in 2023. - The agreement provides commercial certainty for Lupin in a market where Mirabegron had estimated annual U.S. sales of $1.019 billion.
- Lupin Limited received Establishment Inspection Reports (EIR) from the U.S. FDA for both its global pharmacovigilance operations in Mumbai and its Inhalation Research Center in Florida. - The Mumbai facility's pharmacovigilance inspection focused on post-marketing adverse drug experience reporting practices and closed with four observations after comprehensive scrutiny. - The Florida inhalation research center, which develops respiratory products for asthma and COPD treatment, received satisfactory VAI status following inspection for a generic Fostair application. - CEO Vinita Gupta emphasized the importance of maintaining highest quality standards and CGMP compliance, particularly during the COVID-19 pandemic when respiratory products are critically needed.
