COMMERCIAL SUPPLY
When an API reaches commercial stage, success depends on more than just process chemistry — it requires scale, reliability, and unwavering regulatory compliance. At Lupin Manufacturing Solutions (LMS), we deliver large-scale commercial API supply trusted by innovators and generics leaders worldwide. Our network of globally accredited facilities and robust supply chain systems ensures uninterrupted API supplies across 70+ markets.
OUR COMMERCIAL SUPPLY SERVICES
Large-Scale API Manufacturing
- Commercial-scale production in multi-ton capacity facilities
- Flexible batch sizes to meet both global blockbuster and niche therapy needs
- Fully validated processes under cGMP guidelines
Regulatory Compliance & Documentation
- Specifications adapted to Phase I, II, or III requirements
- In-process controls and release testing aligned with regulatory expectations
- Provisional impurity acceptance for early phases, tightened controls for late-stage
Analytical Validation & Documentation
- Method validation to ICH Q2 standards
- CoAs, validation protocols, and full analytical reports provided
- Ready-to-submit documentation supporting INDs, NDAs, and global regulatory filings
Stability Programs
- ICH-compliant long-term, accelerated, and stress stability studies
- Zone-specific stability testing to meet regional requirements
- Shelf-life assignment and ongoing monitoring for clinical batches
Packaging, Labeling & Logistics
- Clinical batch packaging and GMP-compliant labeling
- Cold-chain logistics and validated shipping for temperature-sensitive APIs
- Transparent supply chain monitoring and tracking
WHY LMS?
- Trusted Reliability Proven track record in uninterrupted global API supply
- Global Recognition APIs supplied to 70+ markets, supported by 100+ successful regulatory inspections
- Technical Depth Ability to scale complex molecules, including HPAPIs and specialty APIs
- Regulatory Strength Experienced teams managing DMFs and post-approval lifecycle globally
- End-to-End Continuity From preclinical and clinical supply to full-scale commercialization under one partner
FAQs
What is your commercial production capacity?
How does LMS ensure uninterrupted supply?
Can LMS manage post-approval regulatory changes?
Do you handle APIs requiring high containment?
How do you integrate sustainability into commercial supply?
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