北大医药重庆大新药业股份有限公司
Chongqing Daxin Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
27
27 products shown
🇺🇸 DMF
17
17 products shown
🇪🇺 CEP
5
5 products shown
Total
49
registrations
🇨🇳 CDE 注册 (27)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Acetylkitasamycin 乙酰吉他霉素 | 178234-32-7 | Class A | Y20190001944 |
| Amikacin 阿米卡星 | 37517-28-5 | Class A | Y20190002404 |
| Amikacin Sulfate 硫酸阿米卡星 | 39831-55-5 | Class A | Y20190001958 |
| Coriolus Versicolor Polysaccharide 云芝胞内糖肽 | - | Class A | Y20190001938 |
| Daptomycin 达托霉素 | 103060-53-3 | Class A | Y20210000436 |
| Erythromycin 乳糖酸红霉素 | 114-07-8 | Class A | Y20190002402 |
| Ferrous Gluconate 葡萄糖酸亚铁 | 299-29-6 | Class A | Y20190001966 |
| Hydroxyethylstarch 羟乙基淀粉130/0.4 | 9005-27-0 | Class A | Y20190006628 |
| Inositol 肌醇 | 87-89-8 | Class A | Y20190001961 |
| Kanamycin Monosulfate 单硫酸卡那霉素 | 25389-94-0 | Class A | Y20190002398 |
| Kitasamycin Tartrate 酒石酸吉他霉素 | 37280-56-1 | Class A | Y20190001945 |
| Kitasamycin Tartrate 酒石酸吉他霉素 | 37280-56-1 | Class A | Y20190001939 |
| Lovastatin 洛伐他汀 | 75330-75-5 | Class A | Y20190001940 |
| Meleumycin 麦白霉素 | 149370-53-6 | Class A | Y20190001943 |
| Midecamycin 乙酰麦迪霉素 | 35457-80-8 | Class A | Y20190001935 |
| Mycophenolate Mofetil 吗替麦考酚酯 | 128794-94-5 | Class A | Y20190001329 |
| Mycophenolate Sodium 麦考酚钠 | 37415-62-6 | Class A | Y20230001249 |
| Oxytetracycline 土霉素 | 79-57-2 | Class A | Y20190001936 |
| Potassium Chloride 氯化钾 | 7447-40-7 | Class A | Y20190001967 |
| Prednisolone 盐酸赖氨酸 | 50-24-8 | Class A | Y20190001965 |
| Riboflavin Tetrabutyrate 核黄素四丁酸酯 | 83-88-5 | Class A | Y20190001932 |
| Sodium Chloride 氯化钠 | 7647-14-5 | Class A | Y20190007759 |
| Tobramycin 妥布霉素 | 32986-56-4 | Class A | Y20190001949 |
| Vancomycin 万古霉素 | 1404-90-6 | Class I | Y20230000840 |
| Vancomycin 万古霉素 | 1404-90-6 | Class I | Y20210000777 |
| Xylitol 木糖醇 | 488-81-3 | Class A | Y20190001937 |
| Zinc Gluconate 葡萄糖酸锌 | 4468-02-4 | Class A | Y20190001934 |
🇺🇸 DMF 注册 (17)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Amikacin Base 硫酸阿米卡星等8个原料药（详见品种信息表） | 37517-28-5 | - | 1998-09-01 |
| Amikacin Hydrochloride, Non-sterile Bulk Drug | - | - | 1999-03-05 |
| Amikacin Sulfate (1:1.8) USP, Non-sterile Bulk Drug Substance | 39831-55-5 | - | 2007-11-09 |
| Amikacin Sulfate (1:2) USP | 39831-55-5 | - | 1998-09-01 |
| Daptomycin 达托霉素 | 103060-53-3 | - | 2011-03-04 |
| Daptomycin, Non-sterile, Bulk Drug 达托霉素 | 103060-53-3 | - | 2015-11-12 |
| Lovastatin 洛伐他汀 | 75330-75-5 | - | 1997-03-02 |
| Lovastatin, USP 洛伐他汀 | 75330-75-5 | - | 1997-05-08 |
| Mevastatin | 73573-88-3 | - | 2008-11-14 |
| Mycophenolate Mofetil 吗替麦考酚酯 | 128794-94-5 | - | 2009-07-22 |
| Mycophenolate Mofetil, Non-sterile Bulk Drug Substance 吗替麦考酚酯 | 128794-94-5 | - | 2007-08-07 |
| Mycophenolate Sodium 麦考酚钠 | 37415-62-6 | - | 2024-06-25 |
| Mycophenolic Acid | 24280-93-1 | - | 2009-08-24 |
| Sirolimus 西罗莫司 | 53123-88-9 | - | 2009-09-14 |
| Tobramycin Form-1 USP 妥布霉素 | 32986-56-4 | - | 2006-06-07 |
| Tobramycin USP 妥布霉素 | 32986-56-4 | - | 1998-09-01 |
| Vancomycin Hydrochloride 盐酸去甲万古霉素 | 1404-90-6 | - | 2015-01-29 |
🇪🇺 CEP 注册 (5)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Milbemycin Oxime For Veterinary Use | 129496-10-2 | R0-CEP 2020-241 - Rev 00 | - |
| Mycophenolate Mofetil 吗替麦考酚酯 | 128794-94-5 | R0-CEP 2020-104 - Rev 00 | - |
| Tobramycin 妥布霉素 | 32986-56-4 | R1-CEP 1997-103 - Rev 07 | - |
| Tobramycin, Ehs Optimized Process 妥布霉素 | 32986-56-4 | CEP 2019-036 - Rev 02 | - |
| Vancomycin Hydrochloride 盐酸去甲万古霉素 | 1404-90-6 | CEP 2018-197 - Rev 01 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01