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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by China Sinopharm International Corp. to the U.S. FDA. Original Data : FDA Website

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01 6-AMINOPENICILLANIC ACID (1)

02 7-AMINOCEPHALOSPORANIC ACID (1)

03 AMOXICILLIN TRIHYDRATE (COMPACTED POWDER) (1)

04 AMOXICILLIN TRIHYDRATE (POWDER) (1)

05 AMOXICILLIN TRIHYDRATE, USP (1)

06 AMPICILLIN TRIHYDRATE (POWDER) (1)

07 AZITHROMYCIN DIHYDRATE (1)

08 CASPOFUNGIN ACETATE (1)

09 CEFTRIAXONE SODIUM (NON-STERILE BULK) USP (1)

10 CEFTRIAXONE SODIUM, USP (1)

11 CEFUROXIME AXETIL (1)

12 CLAVULANATE POTASSIUM DILUTED 1:1 WITH MICROCRYSTALLINE CELLULOSE (1)

13 CLAVULANATE POTASSIUM DILUTED 1:1 WITH SILICON DIOXIDE (1)

14 CLAVULANATE POTASSIUM, USP (1)

15 DEACETYL-7-AMINOCEPHALOSPORANIC ACID (D-7-ACA) (1)

16 DEACYL CEFTRIAXONE (7-ACT) (1)

17 HUMAN CHORIONIC GONADOTROPIN (1)

18 MANUFACTURING FACILITIES FOR CHORIONIC GONADOTROPIN IN CHINA (1)

19 MENOTROPINS (1)

20 MICAFUNGIN SODIUM (1)

21 PNEUMOCANDIN B0 (1)

22 PNEUMOCANDIN M1 (1)

23 RITALINIC ACID (2)

24 UROKINASE (1)

25 ZIDOVUDINE (1)

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01 CHINA NATIONAL PHARMACEUTICAL FOREIGN TRADE CORP (2)

02 SHANGHAI BIOCHEMICAL AND PHARMACEUTICAL LABORATORIES (4)

03 SHANGHAI SHYNDEC PHARMACEUTICAL HAIMEN CO LTD (2)

04 SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTD (4)

05 SINOPHARM WEIQIDA PHARMACEUTICAL CO LTD (14)

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01 China (26)

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01 Active (16)

02 Inactive (10)

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01 Complete (7)

02 Blank (19)

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SINOPHARM WEIQIDA PHA...
Active
30779
N/A
2016-08-02
II
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SINOPHARM WEIQIDA PHA...
Active
30473
N/A
2016-05-09
II
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SINOPHARM WEIQIDA PHA...
Active
36698
Complete
2022-03-16
2022-03-07
2022-02-13
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SINOPHARM WEIQIDA PHA...
Active
36579
Complete
2022-03-14
2022-03-04
2021-12-23
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SINOPHARM WEIQIDA PHA...
Active
32811
N/A
2018-05-15
II
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SINOPHARM WEIQIDA PHA...
Active
38056
N/A
2023-03-30
II
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SHANGHAI SHYNDEC PHAR...
Active
30887
Complete
2021-09-13
2021-06-24
2016-12-29
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SHANGHAI TECHWELL BIO...
Inactive
29682
N/A
2015-11-12
II
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SINOPHARM WEIQIDA PHA...
Active
33501
N/A
2019-02-28
II
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SINOPHARM WEIQIDA PHA...
Inactive
33015
N/A
2018-08-01
II
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