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Lupin Limited

Global pharmaceutical manufacturer with FDA, MHRA, and EU GMP-aligned quality systems.

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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.

Fill-finish formats

Regulatory clearances

Services

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

AuthorityIdentifierSource
US FDAFDA-compliant manufacturing sitesView
EMAEU GMP-aligned operationsView
UK MHRAUK MHRA-aligned regulatory systemsView
FDAUS FDAView
EMAEU GMPView
MHRAUK MHRAView
US FDAUS FDAView
UK MHRAUK MHRAView
EU GMPEU GMPView

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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