Built to be filed, inspected and audited
As an API manufacturer for regulated markets, our quality system is the product. Everything below is documented and available for your qualification process.
End-to-end quality control
A GMP quality management system covering R&D, synthesis, purification and release testing, aligned with ICH Q7 for active pharmaceutical ingredients.
Registration documentation
US-DMF, EDMF/ASMF and Written Confirmation packages prepared for filings in the US, EU, Canada and other regulated regions.
Audits welcome
We host customer and regulatory on-site audits and support supplier questionnaires throughout qualification.
Custom specification
Particle size, bulk density, polymorph and salt form tailored to your formulation, to the latest USP / EP / CP editions.
Verified registration & compliance records
Reference numbers of documents buyers can verify with the issuing authorities — FDA FEI numbers, EU Written Confirmations from the Guangdong MPA, NMPA approvals.
| Document | Reference | Scope | Date |
|---|---|---|---|
| FDA EIR (Establishment Inspection Report) | FE 3003677845 | API manufacture, Shenzhen site | 2025-02-17 |
| EU WC (Written Confirmation for API import into the EU) | GD250011 | Phenylephrine Hydrochloride | 2025 |
| EU WC | GD250028 | Doxylamine Succinate | 2025 |
| EU WC | GD250027 | Etilefrine HCL | 2025 |
| EU WC | GD250019 | Epinephrine (Adrenaline) / Bitartrate | 2025 |
| EU WC | GD240004 | Norephedrine / Norepinephrine family | 2024 |
| FDA CPP | H9AE-5J4P | Doxylamine Succinate — export to Mexico | 2025-12-15 → 2027-12-15 |
| 化学原料药上市申请批准通知书 | 2024YS00075 | Epinephrine (Adrenaline) | 2024-01-31 → 2029-01-30 |
Scanned certificates are released to qualified buyers on request — write to us or use the RFQ form and tick the document you need.
Regulatory dossier types we support
Available under NDA for qualified products.
US-DMF
US Drug Master File
EDMF / ASMF
EU Active Substance Master File
CEP
Certificate of Suitability (EDQM)
Written Confirmation
EU FMD import document
CoA / Specification
Batch analysis & standards
GMP certificate
Site GMP certification
Request our quality & compliance package
Products are exported to regulated and semi-regulated markets worldwide.