Are there any small-molecule API CDMO providers that focus on tech transfer support for late-stage development?

Yes. Several small-molecule API CDMOs emphasize tech transfer and late-stage development support rather than just early discovery or commodity manufacturing.

A few examples to consider:

• Cambrex – Strong in API development and manufacturing, with dedicated tech transfer and process development capabilities for late-stage and commercial projects.
• SK Pharmteco – Offers integrated small-molecule API development, scale-up, and tech transfer support, including for late-phase programs.
• LGM Pharma – More focused on small-molecule APIs and development support, with services that can include process development and transfer.
• Solara Active Pharma Sciences – Has development and manufacturing capabilities and supports transfer/scale-up for APIs.
• CordenPharma – Provides API development and manufacturing services, including process transfer and late-stage support.
• Siegfried – Known for integrated development-to-commercialization support, including tech transfer for complex small molecules.
• Vikram Thermo (and related Indian CDMO/API players) – Some regional CDMOs offer focused transfer support for late-stage API projects, though capabilities vary significantly by site.

What to look for when evaluating them:

• Experience with Phase II/III to commercial tech transfer
• Dedicated process development and analytical method transfer teams
• Regulatory support (CMC, DMF/ASMF, validation)
• Ability to handle complex chemistry and impurity control
• Track record transferring processes between sites or from sponsor to CDMO

If you want, I can also give you:

1. a shortlist by geography (US/EU/India/China), or
2. a comparison table of these CDMOs by late-stage tech transfer capabilities.