Summary of Apis/enterprises that have passed FDA certification in China)

Summary of API/enterprise that has passed FDA certification in China. You are welcome to add this article! Summary of Chinese raw materials/enterprises that have passed FDA certification in the United States. We hope this information will be useful to you.

(Note: Only the DMF number is used, and the qualified approval letter for the cGMP check is not included in the statistical scope.
Only those who have passed the COs certification in Europe but have not passed the FDA certification are not included in the statistics)

Sequence No., raw material and medicine name, production manufacturer, backup Injection
1. deoxycyline antibiotics from Kunshan Oriental Pharmaceutical Factory
2. deoxycyline monohydrate, A deoxycyline water-containing force-tetracycline, an antibiotic from Kunshan Oriental Pharmaceutical Factory
3. Tetracycline Hydrochloride tetracycline hydrocloride Ningxia qiyuan Pharmaceutical Industry Limited Antibiotics
4. lincomycin hydrochloride antibiotics in Suzhou No. 4 Pharmaceutical Factory
5. Clindamycin Phosphate the fourth pharmaceutical factory in Suzhou
6. clilin hydrochloride clindamycin Chongqing kailin Pharmaceuticals Company Antibiotics
7. Penicillin potassium penicillin potassium Jiangxi Dongfeng Pharmaceutical Co., Ltd. Antibiotics
8. Tetracycline oxytetracycline Chifeng pharmaceutical antibiotics
9. Tetracycline Hydrochloride oxytetracycline hydrocloride Chifeng pharmaceutical antibiotics
10. ADM hydrochloride adriacin hydrocloride Zhejiang haizheng Pharmaceutical Co., Ltd. Antibiotics
11. rouerythromycin hydrochloride daunomycin hydrochloride Zhejiang haizheng Pharmaceutical Co., Ltd. Antibiotics
12. MMC mitomycin Zhejiang haizheng Pharmaceutical Co., Ltd. Antibiotics
13. tobramycin base Zhejiang haizheng Pharmaceutical Co., Ltd. Antibiotics
14. Avermectin Ivermectin Zhejiang haizheng Pharmaceutical Co., Ltd. Antibiotics
15. boletetracycline sulfate bleomycin sulphate Zhejiang haizheng Pharmaceutical Co., Ltd. Antibiotics
16. fluorouracil deoxyriboside: anti-virus and anti-tumor medicine of Zhejiang haizheng Pharmaceutical Co., Ltd.
17. ifosfamide Jiangsu hengrui Pharmaceutical Co., Ltd.
18. zuye Yiya etoposide Jiangsu hengrui Pharmaceutical Co., Ltd.
19. mesnaum, sodium 2-mercaptoethanesulphonate Jiangsu hengrui Pharmaceutical Co., Ltd.
20. Anti-tumor drugs of thiophosphoramide Jiangsu hengrui Pharmaceutical Co., Ltd.
21. Vinorelbine tartrate, vinorelbine, vinbin, Changchun, Jiangsu haosen Pharmaceutical Co., Ltd.
22. amantamine Northeast Pharmaceutical antiviral drugs
23. ramantadine Northeast Pharmaceuticals
24. Levamisole Hydrochloride
25. Alibaba aciclovir, an antiviral drug of Zhejiang qianji Pharmaceutical Co., Ltd.
26. ribavirin Zhaoqing xinghu, Guangdong Province Biotechnology Star Lake Biochemistry Pharmaceutical Manufacturers
27. SM2 southwest synthetic pharmaceutical company limited antibacterial drugs
Shanghai 3D Pharmaceutical Co., Ltd.
Beijing No. 2 Pharmaceutical Factory
Zhejiang xinsaike Pharmaceutical Co., Ltd.
28. sm2na southwest synthetic pharmaceutical company limited antibacterial drugs
Shanghai 3D Pharmaceutical Co., Ltd.
29. tmp (tritrigger) Southwest synthetic Pharmaceutical Co., Ltd. Antibacterial
30. SMZ (sulfamethoxazolum) Southwest synthetic pharmaceutical company limited antibacterial
31. SD (sulsulfadiazine) Southwest synthetic pharmaceutical company limited antibacterial drugs
Shanghai 3D Pharmaceutical Co., Ltd.
32. sulfaquinoxaline (SQ), Shanghai 3D Pharmaceutical Co., Ltd.
33. Antibacterial drugs of sulfaquinoxaline sodium Shanghai 3D Pharmaceutical Co., Ltd.
34. sulfonamide sodium sulfamerazine sodium (SM1-Na) Shanghai 3D Pharmaceutical Co., Ltd. Antibacterial
35. Antibacterial drugs of sulfathiazole Shanghai 3D Pharmaceutical Co., Ltd.
36. ormetoprim (OMP), Shanghai 3D Pharmaceutical Co., Ltd.
37. florfenicol (FFC) Shanghai 3D Pharmaceutical Co., Ltd. Antibacterial
38. ketoprofen, an anti-inflammatory and analgesic drug Company Limited
39. Ibuprofen ibuprofen Juhua Pharmaceutical Factory anti-inflammatory and analgesic
Xinhua Pharmaceuticals
40. naproxen Zhejiang qianji Pharmaceutical Co., Ltd. anti-inflammatory and analgesic drugs
41. baotaisong butylpyridin Shanghai Fahrenheit Pharmaceutical Co., Ltd. (15th Pharmaceutical Factory) anti-inflammatory drugs
42. Deploy noradrenalini bitartras Wuhan wuyao Pharmaceutical Co. Ltd.
43. Ephedrine ephedrini hydrochloride Chifeng pharmaceuticals adrenaline Receptor
44. ephedrine extract powder Chifeng pharmaceuticals adrenaline Receptor Activator
45. Clozapine Shanghai Fahrenheit Pharmaceutical Co., Ltd. (15th Pharmaceutical Factory)
Guangdong Huizhou Dongjiang Pharmaceutical Factory
46. Ibuprofen therophylline Xinhua Pharmaceutical oral medicine, cardiac excitory medicine, smooth muscle relaxation medicine
47. bumetani bumetanide, a pharmaceutical factory in Guilin
48. linopuli lisinopril Zhejiang huahai Pharmaceutical Co., Ltd. antihypertensive drugs
49. Warfarin captopril Shandong Weifang Pharmaceutical Factory Co., Ltd. antihypertensive drugs
50. Metformin hydrochloride deltamine Shanghai Fahrenheit Pharmaceutical Co., Ltd. (15th Pharmaceutical Factory) hypoglycemic agents
51. Vecuronium Zhejiang Xianju Pharmaceutical Co., Ltd. mysong medicine
52. Sugar and aluminum sucralfate Northeast Pharmaceutical anti-ulcer acid resistance
53. yuchuangmu phenol glycerol ether guaifenesin tianyao Co., Ltd. Tianjin xinxin Pharmaceutical Factory Zhike phlegm
54. meisuo bamo methocarbamol tianyao Co., Ltd. Tianjin xinxin Pharmaceutical Factory cough and phlegm medicine
55. Prednisone prednisone Tianjin tianyao Pharmaceutical Co., Ltd.
56. Hydrocortisone Xinhua Pharmaceutical adrenal cortex hormones
57. CsA (cyclosporin A) immune inhibitor of Fujian kerui Pharmaceutical Co., Ltd.
58. graiseqiong hydrochloride, Hubei Baike Pharmaceutical Co., Ltd., Tumor Chemotherapy and antivomit medicine
59. Anti-tumor drug of Hubei Baike Pharmaceutical Co .,.
60. Multiple Varieties (unknown) Leshan sanjiu changzheng Pharmaceutical Co., Ltd. Antibiotics
61. Penicillin B (amphotericin B) antibiotics of China Pharmaceutical Group Huasheng Company
62. metolazone Xi'an libang Pharmaceutical Co., Ltd. diuretic and Antihypertensive Drugs
64. Levamisole Hydrochloride