CDMO & CMO

Smilax provides custom research and contract manufacturing services of APIs and intermediates for global companies, covering a wide range of therapeutic areas.

Contract Development and Manufacturing Organization (CDMO)

Smilax provides comprehensive services that span the entire drug development lifecycle, including R&D, process optimization, trial batch manufacturing, and commercial-scale production. We provide cost-saving and faster time-to-market by streamlining development, regulatory support, and manufacturing under one roof.

Services Offered:

  • Process Development: Development and optimization of API synthesis routes, including scale-up capabilities
  • Analytical Development: Method development, validation, and stability testing for APIs.
  • Regulatory Support: Assistance with regulatory documentation (DMF, CMC sections) and compliance with regulatory bodies like FDA, EMA, etc.
  • Technology Transfer: Transferring processes from R&D to manufacturing at a commercial scale for both in-licensing and out-licensing
  • Commercial Manufacturing: Supply of APIs for full-scale commercial production

Process Development: Development and optimization of API synthesis routes, including scale-up capabilities

Analytical Development: Method development, validation, and stability testing for APIs.

Regulatory Support: Assistance with regulatory documentation (DMF, CMC sections) and compliance with regulatory bodies like FDA, EMA, etc.

Technology Transfer: Transferring processes from R&D to manufacturing at a commercial scale for both in-licensing and out-licensing

Commercial Manufacturing: Supply of APIs for full-scale commercial production

Capabilities & Infrastructure:

  • Well-equipped R&D Centre with 60+ Scientists
  • We carry out conventional chemical reactions like Catalytic Hydrogenations, Cyanation, Grignard, Halogenations, Nitrations, Friedel-Krafts and Specialized chemical reactions based on customer requirements.