India 
USA
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Philippines
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Mexico
Brazil
Canada
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Lupin Biotech CDMO offers world-class, globally compliant manufacturing infrastructure with flexible, scalable, and cost-efficient solutions. Our end-to-end capabilities — from cell line development to drug product — are designed to support clinical and commercial production, while ensuring the highest levels of quality, compliance, and operational efficiency.
Lupin provides fully integrated CDMO manufacturing services including:
Drug Substance Manufacturing
Mammalian and microbial platforms with single-use bioreactors (10L – 2000L)
Drug Product Manufacturing
Fill-finish for vials, PFS, autoinjectors, and includes lyophilization
Packaging & Assembly
Fully automated primary and secondary packaging with serialization
Regulatory Support
LIND/IMPD and BLA/MAA filings, global eCTD dossier preparation, scientific advice briefing book preparation and meeting support
Tech Transfer
Seamless scale-up from R&D to commercial scale
Supply Chain
Global logistics, cold-chain storage, and end-to-end coordination.
Located in Village Ghotawade, Taluka-Mulshi, this flagship site is the centre of Lupin’s biologics operation and is home to the development, manufacturing, QA/QC, and regulatory teams.
- Workforce: 600+ highly skilled professionals
- Scope: Development and Commercialization of Biosimilars for global markets
- Technologies: Mammalian and microbial platforms
- Compliance: Approved by EMA, PMDA, and other International agencies
- Bioreactor Capacity: 11,000L total (multiple 200L, 1000L and 2000L Single-Use Bioreactors) with expansion possible to 15,000L
- Regulatory Approvals: EMA, Health Canada, TGA and PMDA
- Function: Commercial-scale manufacturing of mAbs, fusion proteins, and other complex biologics produced using mammalian cell culture
- Design: Modular, single-use systems for flexibility and contamination control, including individual and separate critical air-handling systems
- Reactors: 30L and 100L stainless-steel fermentors
- Planned Expansion: To accommodate larger-scale production
- Focus: Manufacture of biologics expressed in microbial systems (e.g. E. coli)
- Supports: Process development, pilot, and small-to-mid-scale commercial production
- Approved by EMA and PMDA
- Annual capacity of 1 million units (vials and PFS)
- Integrated with DS operations for seamless tech transfer
- Serialiszation and aggregation-ready
- Designed for global regulatory compliance and high-volume production
- Approved by FDA, EMA, PMDA, Health Canada, TGA
- Annual capacity of 10 million vials and 16 million PFS units
- Equipped with autoinjector assembly instrumentation
- Fully automated secondary packaging lines
- Serialization and aggregation-ready
- Designed for global regulatory compliance and high-volume production
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Abilities
Lupin offers unmatched flexibility and scalability in manufacturing
DS Scale: 200L to 2000L Single-Use Bioreactors (SUBs)DP Scale: Up to 10 million vials and 16 million PFS units annuallyPlatforms: CHO, SP2/0, and E. coli expression systemsProduct Types: mAbs, fusion proteins, recombinant peptide and proteins, ADCsFill-Finish Formats: Vials, Pre-filled Syringes (PFS), Autoinjectors & lyophilized products -
Drug Substance Facility
Our drug substance facilities are configured for Mammalian and microbial lines with dedicated process systems and comprehensive environmental controls ensuring consistency, safety, and regulatory compliance for every batch produced
Mammalian (Mode 1–4) and separate Microbial facilitiesBioreactors: 200L to 2000L SUBs and separate stainless-steel fermentorsFully equipped with chromatography systems, refolding vessels, virus filtration units, and all required cleanroom support utilitiesTerminal HEPA Filtration, Facility Monitoring Systems (FMS), 24/7 environmental controls and emergency power back-up -
Drug Product Facility
Lupin’s DP capabilities ensure efficient, high-volume fill-finish operations:
Combination filling instrumentation for vials and PFS, with dedicated product contact componentsLyophilization capability and sterile processingAutoinjector assembly lines and flexible packaging formatsSerialization and aggregation features for global traceabilityVisual inspection booths and dedicated cleanroom areas with FMS -
Quality Control
Lupin’s Quality Control Laboratories deliver a full suite of analytical and microbiological testing to ensure that every product meets the most stringent global standards across all stages. Rigorous Quality testing anchored in Regulatory requirements and scientific precision
Analytical Testing: HPLC, UPLC, Capillary Electrophoresis, SpectrophotometryMicrobiology Labs: Sterility, endotoxin, bioburden, and environmental monitoringBioassays: Cell-based and ligand-binding assays for potency and functionChromeleon® and LabSolutions-based chromatography networksTemperature-controlled sample storage for retained/stability samples -
Quality System
Our robust Quality Systems are designed to ensure operational transparency, regulatory readiness, and continuous improvement. Powered by electronic document management, digital logs, and integrated SAP systems, Lupin’s Quality framework supports the full product lifecycle from GMP documentation to audit readiness
Lupin’s facilities follow global best practices in Quality Assurance and documentation:
Electronic Document Management System (EDMS)Electronic logs for cleaning, maintenance, calibration, and usageSAP integration for materials, production processes, and overall Quality managementLaboratory Information Management System (LIMS)Employee training via a qualified electronic documentation system (SABA) for SOPs, EOPs, and protocols -
Storage Facility
Lupin’s advanced storage infrastructure supports both in-process and final product warehousing:
Capacity for 2,000+ pallets with rail-mounted compactorsCold chain storage: 2–8°C, -15 to -25°C, -70 to -90°C, below -135°C for cell banksIntegrated WMS and Weighing & Dispensing (WiNDs) systemsSegregated zones for quarantined, released, rejected and to be returned goodsFMS for real-time environmental monitoring of temperature, humidity, and pressure
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Trials and Testing
Beyond manufacturing, Lupin provides access to preclinical toxicology studies and safety studies in healthy human volunteers through our internal infrastructure and qualified networks. This allows clients to streamline early-stage development and de-risk the pathway from lab to first-in-human studies — all under one roof
Lupin offers:
1.Preclinical toxicology studies for client-manufactured products2.Phase I human trials in healthy volunteers conducted at clinical units in India3.Streamlined integration of development, production, and testing under a single service umbrella