Export documentation prepared per destination.
EU Written Confirmation held · CEP under preparation · EP/USP specifications
Open market page → MarketsChP DMF on file · registrations held by our manufacturing base
Open market page → MarketsANVISA zero-deficiency inspection at our manufacturing base (2025)
Open market page → MarketsCOPP available · DMF on file · registration track record via our base
Open market page → MarketsEU Written Confirmation held · CEP under preparation · multi-pharmacopoeia specs
Open market page →| Document | Status |
|---|---|
| Certificate of Analysis (COA) — 3 commercial batches | Available |
| Drug Master File (ChP / USP / EP) | Available |
| Written Confirmation (WC) — EU | Available |
| COPP | Available |
| GMP certificate | Available |
| CTD Module 3 (S.1–S.7) | Available |
| Stability data — ICH Q1A, Zone II & IVb | Available |
| TSE / BSE & GMO free statement | Available |
| ICH Q3C / Q3D & nitrosamine assessment | Available |
| CEP (EDQM) | In application |
A five-day on-site GMP inspection by Brazil's ANVISA was closed with zero deficiencies. Together with EU GMP and the Written Confirmation, it is the fastest way for a new buyer to judge whether our manufacturing base can hold your specification.
Source: announcement 2025-023 of Zhejiang Hichi Pharmaceutical (NEEQ: 834402) and announcement 2025-097 of Beijing Beilu Pharmaceutical (300016), both dated 2 September 2025. Certificate holder: Zhejiang Hichi Pharmaceutical Co., Ltd. – our manufacturing base.
Tell us grade, pharmacopoeia, quantity and destination. We reply with COA sample, MSDS and a price proposal.
