APIs & Intermediates
Botanical＆Animal Derivative APIs
Oncology APIs
Advanced Intermediates
Product List DownloadBotanical＆Animal Derivative APIs
| Rutin & its derivatives | Spec | GMP | DMF |
|---|---|---|---|
| Rutin | EP/DAB 10/NF11 | China GMP/UK MHRA | Available |
| Troxerutin | EP/DAB/CP | China GMP | Available |
| Quercetin | Dihydrate /HBD | — | — |
| Rutin Water Soluble | In-House | — | — |
| Citrus Aurantium L.Series | Spec | GMP | DMF |
|---|---|---|---|
| Hesperidin | EP/USP | China GMP | Available |
| Diosmin | EP/9:1 | China GMP、EUGMP | Available |
| Cholic Acid Series | Spec | GMP | DMF |
|---|---|---|---|
| Obeticholic Acid | In-House | — | — |
| Tauroursodeoxycholic Acid | In-House | — | — |
| Ursodeoxycholic Acid | EP6/EP9/USP41/JP17/Micro Powder | China GMP | Available |
| Other Extracts | Spec | GMP | DMF |
|---|---|---|---|
| Cytisine | In-House | — | Available |
| Natural Indigo | In-House | China GMP | — |
| Artemisinin | In-House | — | — |
| Berberine Hcl | CP/JP | China GMP | — |
| Rotundine | CP | China GMP | — |
| Zizyphus Spinosa Extract | In-House | — | — |
| ACTH | In-House | — | — |
Oncology APIs
| Camptothecin Series | Spec | GMP | DMF |
|---|---|---|---|
| Irinotecan Hcl | EP/USP/JP | China GMP、Japan GMP | Available |
| 10-Hydroxy-CPT | In-House | China GMP | — |
| Topotecan Hcl | In-House | — | — |
| -nibs | Spec | GMP | DMF |
|---|---|---|---|
| Erlotinib | Form A/Form B | Mexico COFEPRIS | Available |
| Nilotinib | Anhydrate/Monohydrate/Dihydrate/Free Base | — | Available |
| Gefitinib | FormⅠ | CEP | Available |
| Dasatinib | Anhydrate / Monohydrate | — | — |
| Sorafenib | FormⅠ/Form Ⅲ | — | — |
| Sunitinib | In-House | — | — |
| Tofacitinib | CITRATE | — | — |
| Regorafenib | In-House | — | — |
| Cabozantinib Malate | Malate | — | — |
| Others | Spec | GMP | DMF |
|---|---|---|---|
| Ingenol Mebutate | In-House | — | Available |
| Cabazitaxel | Monohydrate | — | Available |
| Anastrozole | EP/USP | EUGMP | Available |
| Letrozole | In-House | — | — |
Advanced Intermediates
| Intermediate | Spec | GMP | DMF |
|---|---|---|---|
| SN-38 | In-House | — | — |
| Ingenol | In-House | — | — |
| 3-aminophenylacetylene Hcl | 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
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.