湖北亨迪药业股份有限公司
Hubei Biocause Heilen Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
12
12 products shown
🇺🇸 DMF
16
16 products shown
🇪🇺 CEP
5
5 products shown
Total
33
registrations
🇨🇳 CDE 注册 (12)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Abiraterone 醋酸阿比特龙 | 154229-19-3 | Class A | Y20220000319 |
| Atropine 硫酸阿托品 | 5908-99-6 | Class A | Y20210000435 |
| Balsalazide Sodium 巴柳氮钠 | 80573-04-2 | Class A | Y20190003099 |
| Dexibuprofen 右旋布洛芬 | 51146-56-6 | Class A | Y20190008553 |
| Dexibuprofen 右旋布洛芬 | 51146-56-6 | Class A | Y20190003170 |
| Gatifloxacin 加替沙星 | 112811-59-3 | Class A | Y20190003106 |
| Ibuprofen 精氨酸布洛芬 | 58560-75-1 | Class A | Y20240000003 |
| Icotinib 盐酸埃克替尼 | 610798-31-7 | Class A | Y20240000578 |
| Metoclopramide 盐酸甲氧氯普胺 | 364-62-5 | Class A | Y20230001040 |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | Class I | Y20250001003 |
| Oxaprozin 奥沙普秦 | 21256-18-8 | Class A | Y20190003130 |
| Torasemide 托拉塞米 | 56211-40-6 | Class A | Y20190003152 |
🇺🇸 DMF 注册 (16)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Abiraterone Acetate 醋酸阿比特龙 | 154229-18-2 | - | 2017-03-03 |
| Atropine Sulfate 硫酸阿托品 | 55-48-1 | - | 2016-01-21 |
| Cladribine Drug Substance NHWD-870 HCl | 4291-63-8 | - | 2024-05-10 |
| Dexibuprofen Drug Substance 右旋布洛芬 | 51146-56-6 | - | 2020-11-09 |
| Dexmedetomidine Drug Substance 盐酸右异可利定 | 113775-47-6 | - | 2021-08-23 |
| Dexmedetomidine Hydrochloride USP | 145108-58-3 | - | 2025-09-29 |
| Fludarabine Phosphate Drug Substance 磷酸氟达拉滨 | 75607-67-9 | - | 2020-04-29 |
| Flumazenil 氟马西尼 | 78755-81-4 | - | 2004-12-12 |
| Granisetron Hydrochloride, Non-sterile Bulk Drug Substance | 107007-99-8 | - | 2005-12-15 |
| Homatropine Hydrobromide | 51-56-9 | - | 2019-09-29 |
| Homatropine Methylbromide | 80-49-9 | - | 2014-07-28 |
| Hyoscyamine Sulfate | 620-61-1 | - | 2014-09-02 |
| Ibuprofen Arginine Drug Substance 布洛芬 | 57469-82-6 | - | 2025-05-14 |
| Ibuprofen USP 精氨酸布洛芬 | 15687-27-1 | - | 2002-01-25 |
| Indocyanine Green USP 吲哚菁绿 | 3599-32-4 | - | 2025-11-22 |
| Milrinone 米力农 | 78415-72-2 | - | 2006-08-31 |
🇪🇺 CEP 注册 (5)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Cladribine 克拉屈滨 | 4291-63-8 | CEP 2023-104 - Rev 00 | - |
| Fludarabine Phosphate 磷酸氟达拉滨 | 21679-14-1 | R0-CEP 2020-136 - Rev 01 | - |
| Granisetron Hydrochloride 盐酸格拉司琼 | 107007-99-8 | CEP 2008-184 - Rev 02 | - |
| Ibuprofen 精氨酸布洛芬 | 58560-75-1 | CEP 2002-099 - Rev 08 | - |
| Torasemide 托拉塞米 | 56211-40-6 | R1-CEP 2006-088 - Rev 02 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01