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Custom Manufacturing Solutions (CMS) Overview

Neuland’s Custom Manufacturing Solutions (CMS) derives from its proven expertise in chemical process development to manufacturing at varied scales, a deep understanding of complex chemical processes and manufacturing. Its facilities are compliant as per cGMP requirement and meeting environment and safety standards.

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/NDA filing support
  • Solid state & pre-formulation technologies

Backed by an excellent compliance history and track record, Neuland manufacturing facilities are equipped for Phase I through commercial API manufacturing. Our CMS business helps customers (both innovator Pharma and Biotech companies) deliver the products on time by providing a range of technology platforms and product services maximizing the value opportunity. We offer both small-scale clinical trial quantities and commercial-scale requirements. We can provide building blocks and cGMP manufacturing of APIs.

Regulatory Support

Neuland has a stellar history of successful regulatory inspections by leading regulatory authorities worldwide. All our manufacturing sites and the R&D center are routinely inspected by global regulatory authorities to ensure our facilities, processes and products meet the strict cGMP standards.

Regulatory support activities for CMS projects/customers

  • CMC document preparation and review
  • Addressing regulatory queries
  • IND/ NDA filing support
  • Changes evaluation


Custom Manufacturing Solutions (CMS) Overview