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The EIR was issued following an inspection of the facility from 08 September 2025 to 16 September 2025.
Nilesh Gupta, managing director, Lupin, said: “We are pleased to have received the EIR from the U.S. FDA with a VAI classification for our Nagpur injectable facility.
We are committed to upholding the highest standards of quality and compliance across our facilities, with continued focus on enhancements to our quality systems and operational excellence.”
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The company had reported a 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025.
The counter rose 0.84% to currently trade at Rs 2107.20 on the BSE.
This milestone underscores Lupin¡¦s commitment to sustainability and decisive climate action, positioning the company among a select group that has achieved comprehensive SBTi validation within a year of setting its climate targets.
Key short-term targets:
„h - Reduce absolute Scope 1 and 2 greenhouse gas emissions by 42.0% by FY 2030, with FY 2023 as the base year.
„h - Reduce Scope 3 greenhouse gas emissions by 61.07% by FY 2033, across purchased goods and services, fuel- and energy-related activities, upstream and downstream transportation and distribution, business travel, employee commuting, processing and use of sold products, and franchises, using FY 2024 as the baseline.
These goals are aligned with the 1.5¢XC pathway and validated under SBTi¡¦s latest guidelines, thereby positioning Lupin as a key participant in the global effort to combat climate change.
Lupin Manufacturing Solutions (LMS), a subsidiary of Lupin, today announced a long-term strategic alliance with PolyPeptide Group AG (PolyPeptide) (SIX: PPGN), a specialized, global CDMO for peptide-based active pharmaceutical ingredients. This collaboration aims to enhance supply chain resilience, improve operational efficiency, and accelerate readiness for the rapidly expanding global peptides market. It also advances next-generation peptide therapeutics, including those for metabolics, supporting the long-term strategic growth of both organizations.
As part of the alliance, both companies will work towards the following: „h
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets, while enhancing PolyPeptide¡¦s position as a trusted CDMO partner.
Realty shares jumped for the two consecutive trading sessions.
At 10:25 IST, the barometer index, the S&P BSE Sensex, advanced 176.76 points or 0.21% to 85,442.08. The Nifty 50 index jumped 55.45 points or 0.21% to 26,089.20.
In the broader market, the S&P BSE Mid-Cap index rose 0.06% and the S&P BSE Small-Cap index added 0.54%.
The market breadth was negative. On the BSE, 1,558 shares rose and 2,014 shares fell. A total of 211 shares were unchanged.
Economy:
The Reserve Bank of India Governor Sanjay Malhotra, announcing the fifth bi-monthly policy review of FY26 said that RBI’s MPC has unanimously decided to reduce the policy repo rate by 25 basis points to 5.25%, keeping its stance neutral.
Buzzing Index:
The Nifty Realty index jumped 1.18% to 900.60. The index rose 1.72% in the two consecutive trading sessions.
Prestige Estates Projects (up 0.87%), Oberoi Realty (up 0.57%), DLF (up 0.56%), Brigade Enterprises (up 0.49%) advanced.
Stocks in Spotlight;
Kesoram Industries surged 19.85% after Frontier Warehousing announced an open offer to acquire 8.07 crore shares, representing a 26% stake, at Rs 5.48 per share.
Lupin shed 0.05%. The company announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Siponimod Tablets in 0.25 mg, 1 mg and 2 mg.
ZEN Technologies advanced 1.68% after the company announced that it has secured orders worth Rs 120 crore from the Ministry of Defence (MoD), Government of India.
Lupin said the tablets will be manufactured at its Pithampur facility in India. According to IQVIA MAT October 2025 data, Siponimod Tablets (reference listed drug Mayzent) recorded annual U.S. sales of USD 195 million.
Lupin reported a 73.33% surge in consolidated net profit to Rs 1,477.92 crore in Q2 FY26 as against Rs 852.63 crore posted in Q2 FY25. Revenue from operations jumped 24.27% year-on-year to Rs 6,831.43 crore in the quarter ended 30 September 2025.
The counter shed 0.21% to Rs 2,087.55 on the BSE.
Siponimod Tablets, 0.25 mg, 1 mg and 2 mg are bioequivalent to Mayzent® Tablets, 0.25 mg, 1 mg and 2 mg of Novartis Pharmaceuticals Corporation, and indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.
Siponimod Tablets (RLD Mayzent®) had estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).
Under the terms of the agreement, Valorum will advance the commercialization and distribution of Armlupeg™ (pegfilgrastim-unne) in the United States. Lupin will be responsible for manufacturing and supply of the product and will receive an upfront license fee and a royalty payment on net sales.
Pegfilgrastim-unne is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.
Armlupeg (pegfilgrastim-unne) is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing chemotherapy.
“We are pleased to collaborate with Valorum to expand access to affordable treatment options for patients undergoing chemotherapy. This partnership reflects our unwavering commitment to improving patient outcomes and aligns with our mission to make high-quality biosimilars more accessible. We look forward to strengthening our presence in the U.S. biosimilars market and building on our momentum as a global leader in developing and commercializing important biosimilar medicines,” said Spiro Gavaris, President – U.S. Generics, Lupin.
Par S. Hyare, CEO of Valorum, said, “We are excited to launch Armlupeg (pegfilgrastim-unne) in the U.S. Our team has a proven track record in specialty markets, and we expect to capture significant market share through our commercial expertise. Crucially, we also look forward to providing another option for healthcare providers and patients, increasing access to this important treatment in oncology supportive care.”
Valorum Biologics specializes in the U.S. commercialization of biosimilars, managing regulatory approval, product launch, and ongoing commercialization. The company focuses on optimizing patient access and delivering cost savings to the healthcare system.
The counter rose 0.47% to Rs 2,090.45 on the BSE.
The product will be manufactured at Lupin's Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval.
Armlupeg™ is indicated for:
- Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Lupin Human Welfare and Research Foundation (LHWRF), the Corporate Social Responsibility (CSR) arm of global pharma major Lupin, has been awarded the CRISIL Voluntary Organisation grading of VO 1A, the highest classification, indicating ‘Very Strong Delivery Capability and High Financial Proficiency.'
This distinction is testament to LHWRF's dedication to excellence, transparency, and impact in the realm of social responsibility. For over 37 years, LHWRF has spearheaded initiatives to improve lives and livelihoods and strengthen healthcare for underserved populations across India. The Foundation remains dedicated to empowering communities and promoting holistic development.
“We are honored to receive the VO 1A rating from CRISIL, reflecting our commitment to social welfare and sustainable growth,” said Tushara Shankar, Head – CSR, Lupin. “This recognition inspires us to expand our innovative programs that support communities and create lasting positive impact.”
The CRISIL VO grading is a comprehensive assessment framework that evaluates an organization's overall ability to deliver on its goals. It focuses on factors such as stakeholder engagement, system and process efficiency, implementation and monitoring mechanisms, and financial management skills, including revenue and expenditure control, resource diversification, liquidity, and transparency reporting.