Global Generic API
Manufacturer
At Lupin Manufacturing Solutions, we recognize that generic APIs form the foundation of global healthcare access. Backed by more than five decades of Lupin’s pharmaceutical legacy, our generic API portfolio is designed to meet the highest standards of quality, scalability, and compliance ensuring that essential medicines remain accessible to patients worldwide.
Our portfolio spans multiple therapeutic categories, including cardiovascular, central nervous system, respiratory, anti-infective, metabolic disorders, and oncology. Each API is developed and manufactured in USFDA-approved facilities, with regulatory documentation (DMFs, CEPs, dossiers) to support smooth global submissions.
Why Partner with us
- Scalable Production
Multi-site manufacturing with redundancy to de-risk supply chains
- Advanced Technology Platforms
Cryogenic chemistry, flow chemistry, and biocatalysis for difficult-to-make APIs
- Sustainability Practices
Waste minimization, solvent recovery, and green chemistry adoption
- Business Continuity Planning
Dual-plant strategies and qualified second sources
- Global Compliance
Facilities inspected by USFDA, ANVISA, WHO, CDSCO and other regulatory agencies
- Comprehensive Documentation
DMFs, CEPs, and eCTD-ready dossiers for major markets
- ICH-Guided Stability
Long-term, intermediate, and accelerated studies to ensure robust shelf life
- Data Integrity by Design
Digitalized systems with audit trails, ALCOA+ compliance, and transparent change control
OUR GENERIC API CATALOG ADDRESSES
A WIDE SPECTRUM OF THERAPEUTIC AREAS
APIs supporting hypertension,cholesterol management,and heart failure
APIs for depression, epilepsy,and neurodegenerative diseases
A broad range including antibacterial and antiviral agents
APIs for asthma, COPD, and allergy management
APIs for diabetes, obesity, and thyroid disorders
APIs for targeted therapies, chemotherapy agents, and supportive treatments
Yes, our APIs are manufactured in compliance with USP, EP standards, and we provide harmonized documentation to ease regulatory submissions.
Yes, we design and implement tailored impurity profiles aligned with client-specific requirements under a quality agreement.
We maintain multi-site manufacturing redundancy, robust safety stock, and qualified second-source suppliers to mitigate supply risks.
Yes, we manage seamless tech transfers within our network or to client sites, supported by detailed documentation and technical assistance.
