Services

More than supply: technical and regulatory support

For customers who need product localization, technical documentation, audits or registration, we provide services that carry a molecule from our facility into your market.

Scope

What we can take on

01

Technology transfer

Complete API technology packages for localizing a product in your market, with content adjusted to your specific needs.

02

Custom synthesis

Synthesis of new compounds in support of your research and development pipeline.

03

Equipment matching

Sourcing and matching of pharmaceutical production equipment for your project.

04

China audit & registration

Audit and product registration support with authorities in Mainland China.

Technology transfer

What an API transfer package includes

For API technology transfer, the package typically covers the documentation and process-control materials listed here — and is adjusted to the regulatory requirements of your target market.

  • General API information and physical description
  • Characterization and proof of structure
  • Workshop equipment and requirements
  • Synthesis route and method of manufacture
  • Process controls, including solvents and impurities
  • Reference standard
  • Specifications and analytical test methods
  • Container closure system
  • Stability data
  • Validation of the process

Start an inquiry

Ready to discuss your requirements?

Send us the product name or CAS number, the quantity you need, and your destination market — our team will respond with specifications, availability and lead times.