Established in 1984, Neuland Laboratories is a leading manufacturer of active pharmaceutical ingredients (APIs) and end-to-end solutions provider for the pharmaceutical industry’s chemistry related services. Our expertise spans across the tech transfer, development, and commercialization of Small Molecules and Peptides for new chemical entities (NCEs), as well as key raw materials and intermediates.
Supported by three world-class US FDA and EU GMP compliant manufacturing facilities and complex chemistry capabilities, Neuland has become a trusted partner for innovator companies.
Our Custom Manufacturing Solutions covers the full range of the pharmaceutical industry’s chemistry requirements, from pre-IND through commercial manufacturing. We offer both small-scale clinical trial quantities and full commercial-scale supply with minimal tech transfer timelines. Our R&D facility is approved by the Department of Scientific and Industrial Research and inspected by the USFDA without any observations. The facility houses development labs, analytical labs, a kilo lab for scale-up and dedicated lab for peptides.
Neuland is reliable manufacturing and development partner to customers in over 80 countries across US, Europe and Japan.
Our Services
• Designing and developing manufacturing processes
• Process optimization for competitiveness
• cGMP manufacturing of APIs & Intermediates – Lab scale to commercial
• Production of Peptides – solid, solution and hybrid manufacturing
• IND-IMPD/NDA filing support
• Solid state & pre-formulation technologies
• Regulatory support activities for CMS projects/customers

Custom Manufacturing Solutions
Phase appropriate process development (early phase to commercial) Analytical method development & validation Process validation Sequential scale-up DoE, QbD, FMEA ICH stability studies Regulatory approved cGMP manufacturing sites (USFDA, EMEA etc.) CMC documentation IND, NDA, DMF filing support

Peptide Synthesis Service (LPPS, SPPS &Hybrid model)
Core Expertise Solution Phase Synthesis Solid Phase Synthesis Hybrid Technology for Complex Peptides Demonstrated expertise in the manufacture of people APIs (5-50 AAs) using solution Phase and hybrid technologies.