Active Pharmaceutical Ingredients
Finished APIs with full regulatory dossiers
Bulk and finished-form APIs across therapeutic categories. All materials supplied with DMF references, CoA, and ICH-compliant stability data from FDA-registered Chinese manufacturers.
Therapeutic Categories
APIs across cardiovascular, CNS, anti-infective, oncology, endocrinology, and respiratory therapeutic areas.
Regulatory Support
DMF filing support, CEP applications, and ASMF documentation available for key markets including US, EU, and Australia.
Manufacturer Vetting
All API manufacturers are personally audited by our China-based team against FDA and ICH Q7 GMP standards before engagement.
At a Glance
Compliance
FDA · ICH Q7
Stability Data
ICH-compliant
Lead Time
6–12 weeks
MOQ
From 500 g
Request an API Dossier
Provide your target API, required specification, and destination market. We will respond with manufacturer profiles and regulatory documentation.