山东鲁抗医药股份有限公司
Shandong Lukang Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
74
74 products shown
🇺🇸 DMF
4
4 products shown
🇪🇺 CEP
3
3 products shown
Total
81
registrations
🇨🇳 CDE 注册 (74)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Acarbose 阿卡波糖 | 56180-94-0 | Class A | Y20220000409 |
| Amlodipine 氨氯地平 | 88150-42-9 | Class A | Y20190002116 |
| Amoxicillin Sodium 阿莫西林钠 | 26787-78-0 | Class A | Y20190009450 |
| Amoxicillin Sodium 阿莫西林钠 | 26787-78-0 | Class A | Y20190002102 |
| Amoxicillin Sodium 阿莫西林钠 | 26787-78-0 | Class A | Y20170001912 |
| Ampicillin 氨苄西林 | 69-53-4 | Class A | Y20190001998 |
| Ampicillin Sodium 氨苄西林钠 | 69-53-4 | Class A | Y20210000576 |
| Ampicillin Sodium 氨苄西林钠 | 69-53-4 | Class A | Y20190001973 |
| Apixaban 阿哌沙班 | 503612-47-3 | Class A | Y20220000046 |
| Aprepitant 阿瑞匹坦 | 170729-80-3 | Class I | Y20230000359 |
| Azlocillin Sodium 阿洛西林钠 | 37091-66-0 | Class A | Y20190002090 |
| Benzyl Alcohol 苯甲醇 | 100-51-6 | Class A | Y20180001488 |
| Benzylpenicillin Potassium 青霉素钾 | 61-33-6 | Class A | Y20190002115 |
| Benzylpenicillin Sodium 青霉素钠 | - | Class A | Y20190002112 |
| Brexpiprazole 布瑞哌唑 | 913611-97-9 | Class I | Y20240001517 |
| Cefadroxil 头孢羟氨苄 | 50370-12-2 | Class A | Y20190001983 |
| Cefalexin 头孢氨苄 | 15686-71-2 | Class A | Y20190002003 |
| Cefamandole Nafate 头孢孟多酯钠 | 34444-01-4 | Class A | Y20190006664 |
| Cefathiamidine 头孢硫脒 | 33075-00-2 | Class A | Y20190005837 |
| Cefazolin Sodium 五水头孢唑林钠 | 25953-19-9 | Class A | Y20190001974 |
| Cefetamet 盐酸头孢他美酯 | 65052-63-3 | Class A | Y20190002037 |
| Cefixime 头孢克肟 | 79350-37-1 | Class A | Y20190001993 |
| Cefmenoxime 盐酸头孢甲肟 | 65085-01-0 | Class I | Y20170000891 |
| Cefminox Sodium 头孢米诺钠 | 84305-41-9 | Class A | Y20190005849 |
| Cefoperazone Sodium 头孢哌酮钠等29个原料药 | 62893-19-0 | Class A | Y20190002002 |
| Cefotaxime Sodium 头孢噻肟钠 | 63527-52-6 | Class A | Y20190001985 |
| Cefpiramide Sodium 头孢匹胺钠 | 70797-11-4 | Class A | Y20190001988 |
| Cefpirome Sulfate 硫酸头孢匹罗/碳酸钠 | 84957-29-9 | Class A | Y20190003657 |
| Cefradine 头孢拉定（口服粉） | 38821-53-3 | Class A | Y20190002105 |
| Cefradine 头孢拉定（口服粉） | 38821-53-3 | Class A | Y20190002103 |
| Ceftezole Sodium 头孢替唑钠 | 26973-24-0 | Class A | Y20190001298 |
| Ceftriaxone Sodium 头孢曲松钠 | 73384-59-5 | Class A | Y20190002101 |
| Celecoxib 塞来昔布 | 169590-42-5 | Class A | Y20230001246 |
| Cephalosporium Powder 虫草头孢菌粉 | - | Class A | Y20190002016 |
| Clindamycin 克林霉素 | - | Class A | Y20190007765 |
| Dapagliflozin HS-10353 | 461432-26-8 | Class A | Y20190000428 |
| Doxofylline 多索茶碱 | 69975-86-6 | Class A | Y20210000238 |
| Doxycycline 盐酸多西环素 | 7164-70-7 | Class A | Y20190002114 |
| Entecavir 恩替卡伟 | 142217-69-4 | Class A | Y20190009841 |
| Entecavir 恩替卡伟 | 142217-69-4 | Class I | Y20180001716 |
| Esomeprazole Sodium 埃索美拉唑镁 | 119141-88-7 | Class A | Y20200000479 |
| Febuxostat 非布司他 | 144060-53-7 | Class A | Y20210001139 |
| Finerenone HS236 | 1050477-31-0 | Class I | Y20250000245 |
| Gefitinib 吉非替尼 | 184475-35-2 | Class A | Y20230000332 |
| Glutamine L-谷氨酰胺 | 56-85-9 | Class A | Y20190002075 |
| Ibrutinib 伊布替尼 | 936563-96-1 | Class I | Y20250000133 |
| Imatinib 硫酸艾玛昔替尼 | 152459-95-5 | Class I | Y20240000532 |
| Lenampicillin Hydrochloride 盐酸仑氨西林 | 69-53-4 | Class A | Y20190002104 |
| Lenvatinib 甲磺酸仑伐替尼 | 417716-92-8 | Class I | Y20230000535 |
| Letermovir 来特莫韦 | 917389-32-3 | Class I | Y20250000637 |
| Levodopa 多巴丝肼颗粒 | 59-92-7 | Class A | Y20220000032 |
| Lincomycin 盐酸林可霉素 | 154-21-2 | Class A | Y20190002020 |
| Lincomycin 盐酸林可霉素 | 154-21-2 | Class A | Y20190002018 |
| Lovastatin 洛伐他汀 | 75330-75-5 | Class A | Y20190002017 |
| Meleumycin 麦白霉素 | 149370-53-6 | Class A | Y20190002015 |
| Mezlocillin Sodium 美洛西林钠 | 51481-65-3 | Class A | Y20190008449 |
| Moxifloxacin 盐酸莫西沙星 | 151096-09-2 | Class A | Y20220000493 |
| Oxytetracycline 土霉素 | 79-57-2 | Class A | Y20190002077 |
| Oxytetracycline Hydrochloride 盐酸土霉素 | 79-57-2 | Class A | Y20190002019 |
| Parecoxib Sodium 帕瑞昔布钠 | 198470-84-7 | Class A | Y20190000049 |
| Piperacillin 哌拉西林 | 61477-96-1 | Class A | Y20220000703 |
| Piperacillin Sodium 哌拉西林钠 | 61477-96-1 | Class A | Y20190002100 |
| Rosiglitazone 罗格列酮 | 122320-73-4 | Class A | Y20190007310 |
| Seratrodast 塞曲司特 | 112665-43-7 | Class A | Y20190006626 |
| Simvastatin 辛伐他汀 | 79902-63-9 | Class A | Y20190001986 |
| Spectinomycin Hydrochloride 盐酸大观霉素 | 1695-77-8 | Class A | Y20190002110 |
| Spiramycin 螺旋霉素 | 24916-50-5 | Class A | Y20190002113 |
| Streptomycin 硫酸链霉素 | 57-92-1 | Class A | Y20190002111 |
| Sulbactam Sodium 舒巴坦钠 | 68373-14-8 | Class A | Y20190002038 |
| Tebipenem Pivoxil 替比培南匹伏酯 | 161715-24-8 | Class I | Y20240001292 |
| Ticagrelor 替格瑞洛 | 274693-27-5 | Class A | Y20190000560 |
| Ticarcillin Sodium 替卡西林钠 | - | Class A | Y20190003670 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class A | Y20210000172 |
| Vonoprazan 富马酸伏诺拉生 | 881681-00-1 | Class I | Y20240000833 |
🇺🇸 DMF 注册 (4)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Manufacturing Site, Facilities, Operating Procedures And Personnel At Jining City, Shandong Province, China | - | - | 1996-08-26 |
| Penicillin G Potassium Bulk Non-sterile Intermediate For Further Processing | 113-98-4 | - | 1996-09-03 |
| Penicillin G Potassium Crude | 113-98-4 | - | 1997-02-26 |
| Spectinomycin Hcl USP, Non-sterile, Bulk Drug Substance 大观霉素 | 21736-83-4 | - | 2011-07-15 |
🇪🇺 CEP 注册 (3)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Levodopa 多巴丝肼颗粒 | 59-92-7 | CEP 2022-202 - Rev 00 | - |
| Spectinomycin Dihydrochloride Pentahydrate 大观霉素 | 22189-32-8 | CEP 2004-166 - Rev 04 | - |
| Spectinomycin Sulfate Tetrahydrate For Veterinary Use 大观霉素 | 64058-48-6 | CEP 2015-198 - Rev 01 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01