Lupin Limited
Global pharmaceutical manufacturer with FDA, MHRA, and EU GMP-aligned quality systems.
Listed on cdmo.directory
Global pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure. Headquartered in Mumbai, India.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Manufacturing (M)
Fill-finish formats
Regulatory clearances
Services
- Quality Control Testing
- Stability Testing & Storage
- CMC Regulatory Submission Support
- Technology Transfer
- Formulation Development
- Process Development
- Inhalation & Nasal Dosage Manufacturing
- Oral Solid Dosage Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- CMC Analytical Development
- Combination Product Assembly & Final Packaging
Indications
About this organization
Lupin Limited is a globally trusted pharmaceutical company founded in 1968, operating a highly diversified manufacturing business across developed and emerging markets. The company maintains a strong regulatory track record with successful inspections and approvals from stringent global regulatory authorities including the US FDA, UK MHRA, and EU GMP.
Quality & Compliance
Quality and compliance are cornerstones of Lupin's operations, guided by the Quality Management Maturity (QMM) model demonstrating a mature, enterprise-wide approach. The company employs:
- Advanced Pharmaceutical Quality Systems with robust, data-driven approaches
- SMART Quality infrastructure including automated PQR, NIR, and bar code-enabled quality control operations
- Electronic Batch Processing Systems, Laboratory Information Management Systems (LIMS), and Electronic Document Management Systems (EDMS)
- Next-generation robotics and integrated ERP platforms
- AI-based solutions for predictive and proactive quality platforms
Manufacturing & Operations
Lupin's manufacturing capabilities span:
- Generics and complex formulations
- Branded products and specialty segments
- Robust R&D and manufacturing infrastructure
- Global presence across 100+ countries
The company is led by 2,000+ quality professionals and a dedicated Corporate Quality Assurance (CQA) organization. Lupin maintains inspection-ready facilities at all times and is committed to manufacturing products of the highest quality from all global manufacturing sites.
Certifications
Locations
Headquarters
Mumbai · Maharashtra · India
Global presence
Multiple
Global presence
Multiple (100+ countries)
Global Operations
Multiple (100+ countries)
Global
Multiple (100+ countries)
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