API development and cGMP manufacturing

Custom Pharma Services has two decades of extensive experience in drug development, cGMP manufacturing for clinical and commercial supplies. Our services are based on our strong technology platforms and include:

 • Complex and multi-step organic synthesis

• Asymmetric synthesis

• Classical resolution

• Organometallic/Metal hydride reactions

• Heterocyclic chemistry

• Halogenations

• Amino sugar chemistry

• Nucleoside synthesis

• High pressure hydrogenation

Our projects affirm our expertise. See Case Studies of our successful projects.

API integrated formulation development and manufacturing

We adopt ‘start with the end’ approach and consider formulation as the target irrespective of the stage at which we service: intermediates, API or formulation. Save time, cost and intellectual resources with our well-integrated product development program. Your API properties would govern the ease of formulation development. Optimise particle size, powder flow properties, solid state characteristics of API at CPS with our integrated API formulation services.

In-house analytical capabilities for analytical method development and validation, solid state analysis and chemical analysis with hyphenated techniques in XRD, DSC, Raman spectroscopy, SEM, SAXS, LC-MS etc.

Our formulation services:

  • Preclinical formulations
  • First-in-human formulations
  • Clinical phase 2 and 3 formulations
  • Commercial manufacturing
  • Life cycle management

For more details learn about Our Technologies and see Case Studies of our successful projects.

Commercial APIs

A portfolio of more than 250 commercial APIs makes us a leading manufacturing partner for generic and pharmaceutical companies across the US, Europe, China, Latin America, Japan, Korea and other emerging markets.

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