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APIs & Intermediates

Product List Download

Botanical&Animal Derivative APIs

Rutin & its derivativesSpecGMPDMF
EP/DAB 10/NF11
China GMP/UK MHRA
Available
EP/DAB/CP
China GMP
Available
Dihydrate /HBD
In-House
Citrus Aurantium L.SeriesSpecGMPDMF
EP/USP
China GMP
Available
EP/MPFF/9:1
China GMP、EUGMP
Available
Cholic Acid SeriesSpecGMPDMF
In-House
EP6/EP9/USP41/JP17/Micro Powder
China GMP
Available
Other ExtractsSpecGMPDMF
In-House
Available
In-House
China GMP
In-House
CP/JP
China GMP
CP
China GMP
In-House

Oncology APIs

Camptothecin SeriesSpecGMPDMF
EP/USP/JP
China GMP、Japan GMP
Available
In-House
China GMP
In-House
-nibsSpecGMPDMF
Form A/Form B
Mexico COFEPRIS
Available
Anhydrate/Monohydrate/Dihydrate/Free Base
Available
FormⅠ
CEP
Available
Anhydrate / Monohydrate
FormⅠ/Form Ⅲ
In-House
CITRATE
In-House
OthersSpecGMPDMF
In-House
Available
Monohydrate
Available
EP/USP
EUGMP
Available
In-House

Advanced Intermediates

IntermediateSpecGMPDMF
In-House
In-House

CDMO Service

Contract R & D and Production:

Contract production:

Clinical Batch Supply

Capacity 1-500kg/Month

EHS System Approved by PSCI

Polymorphism Research

Level D Cleaning Zone: 3535㎡

Process Scale-Up&Validation

Pilot Workshop for Oncology API

Offering Sample by Gram&Kg Level

Development&Optimization of Process

3 Dedicated Lines for Oncology API

Impurity&Genotoxic Impurities Research

Preparative Liquid Chromatography: 100g~1kg

Process Development&Validation Research

NMPA/FDA/PMDA/EDQM/COFEPRIS On-Site Inspection

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Import Registration Service

Preparation import registration:

RA team with rich experience for finished product import registration in China, offering one-stop station service. Customized registration strategy, risk evaluation,dossier submission, registration statue follow-up, fast&efficient response. Relying on rich APIs resource,import of finished product from related APIs will be considered as priority, win-win cooperation first.

API Registration:

RA team with rich experience for API import registration in China, offering Live update of latest policy. Project research,documentation, submission of dossier,eCTD profile

Medical Device Import Registration:

Import registration of medical device, project research, documentation, submission of dossier, etc.
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