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Lupin Biotech offers fully integrated, end-to-end Contract Development and Manufacturing Organisation (CDMO) services, leveraging our deep expertise in Biologics and Regulatory Compliance. With a global footprint spanning North America, Europe, Japan, and emerging markets, we provide cutting-edge capabilities in cell line development, process optimization, clinical and commercial-scale manufacturing, and regulatory support.
We provide comprehensive solutions across the biologics development lifecycle, ensuring efficiency, cost-effectiveness, and compliance with international regulatory standards. Offering a comprehensive suite of CDMO services, covering development, manufacturing, regulatory support, and global supply chain, with expertise in monoclonal antibodies (mAbs), fusion proteins, pegylated proteins, recombinant peptides, and other biologics.
Our service portfolio covers:
Clone Development
- Vector design
- Cloning and transfection
- High producing clone screening
- Cell bank maintenance & characterization
Process Development
- Media design
- Upstream & downstream process development & optimization
- Formulation & device development
- Process characterization & validation
- Scale up / down studies
Analytical Development
- Method development
- Functional assay development
- Method qualification & validation
- Toxicology studies
End-to-End Manufacturing
- Drug substance (Mammalian, Microbial)
- Drug product (Liquid & lyophilized vials, PFS, autoinjectors)
- Labeling & packaging
- Global supply chain
Regulatory Support
- Scientific advice support
- IND filing support
- BLA/MAA filing support
- Regulatory inspection experience with FDA, EMA, PMDA, TGA, Health Canada and several ROW agencies
Project Management
- Cross-functional team management
- Regular program meetings
- Up-to-date timelines & budget tracking
- Vendor management
Development Capabilities
- Expert Chemistry Manufacturing and Control (CMC), regulatory, and manufacturing team with a proven track record in securing global regulatory approvals for biologics.
- Expertise in Drug Substance (mAbs, fusion proteins, pegylated proteins, recombinant peptides, and more) and Drug Product (vials, PFS, autoinjectors, lyophilized products)
Process Development
- Clone & cell line development
- Upstream & downstream process optimization
- Formulation and fill-finish development
- Analytical development and characterization
Manufacturing Capabilities
- Mammalian Drug Substance (DS) facility approved by EMA, PMDA, TGA, and Health Canada
- Microbial DS facility with FDA approval expected in Q3 2025
- Drug Product (DP) & packaging facilities approved by FDA, EMA, PMDA, TGA and Health Canada
- ADC development & manufacturing (DS & DP) through strategic partnerships
- Cost-efficient operations leveraging India-based labor and the right-sized infrastructure
Quality & Compliance
- State-of-the-art facilities in Pune & Nagpur, India
- World-class QA/QC systems, including viral clearance and impurity removal
- Electronic document and quality management systems
Experience and Track record
- Etanercept (Enbrel® biosimilar) approved in Europe, Japan, Canada, Australia and other regions
- Pegfilgrastim (Neulasta® biosimilar) submitted for FDA approval (BLA filed) and approved by Health Canada
- Ranibizumab (Lucentis® biosimilar) submitted for FDA, EMA and Health Canada approval
- Aflibercept (Eylea® biosimilar) & Denosumab (Prolia®, Xgeva® biosimilar) in global Phase III clinical trials
- Successful cloning and process development of multiple other molecules
Lupin Biotech CDMO stands out as a preferred partner due to its:
Proven Industry Track Record
Successful global development, approval and commercialization of biosimilars
Regulatory Excellence
Extensive experience in securing global regulatory approvals for biologics. We can manage your filings for IND/IMPD, BLA/MAA and scientific advice briefing books
Cost-Effective Operations
India-based manufacturing ensures competitive pricing without compromising on quality
Global Supply Chain
Lupin is the 3rd largest supplier of pharmaceuticals to the US market by prescriptions. We take pride in our quality and supply excellence
Innovation & Scalability
Excellence in process development, scale up and proven track record in process optimization to reduce COGS
With an unwavering commitment to quality, compliance, and innovation, Lupin ensures seamless biologics development and commercialization for its partners.
“Lupin Biotech has a proven track record of manufacturing products at scale. We’re a trusted partner, we have rapid turn around times, and we play with complex products.”
Nilesh D Gupta
Lupin Biotech CDMO has a strong global footprint, serving pharmaceutical and biotech companies across regulated and emerging markets, extending across North America, Europe, Japan, and other key regions.
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