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

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01 BIVALIRUDIN (1)

02 BIVALIRUDIN (PROCESS II) (1)

03 CETRORELIX ACETATE (1)

04 DECOQUINATE (1)

05 DESMOPRESSIN ACETATE (1)

06 DESMOPRESSIN ACETATE, NON-STERILE DRUG SUBSTANCE (1)

07 DRONEDARONE HYDROCHLORIDE (1)

08 FULVESTRANT (1)

09 FULVESTRANT INTERMEDIATE (CAS NO.: 875573-66-3) (1)

10 LANREOTIDE ACETATE (1)

11 LIRAGLUTIDE (2)

12 OCTREOTIDE ACETATE (1)

13 OSELTAMIVIR INTERMEDIATE (CAS No.: 651324-08-2) (1)

14 OSELTAMIVIR PHOSPHATE (1)

15 SEMAGLUTIDE (1)

16 TIRZEPATIDE (1)

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01 SINOPEP JIANGSU INC (1)

02 SINOPEP PHARMACEUTICAL INC (1)

03 SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTD (15)

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01 China (17)

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01 Active (12)

02 Inactive (5)

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01 Complete (8)

02 Blank (9)

URL Supplier Web Content
SINOPEP-ALLSINO BIOPH...
Active
32281
Complete
2019-02-15
2018-09-19
2018-06-29
II
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SINOPEP-ALLSINO BIOPH...
Inactive
35259
N/A
2020-09-30
II
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SINOPEP-ALLSINO BIOPH...
Active
35171
Complete
2021-08-26
2020-09-28
2020-09-29
II
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SINOPEP-ALLSINO BIOPH...
Inactive
31220
N/A
2017-02-12
II
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SINOPEP-ALLSINO BIOPH...
Active
37799
N/A
2023-01-16
II
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SINOPEP PHARMACEUTICA...
Inactive
20752
N/A
2007-07-28
II
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URL Supplier Web Content
SINOPEP JIANGSU INC
Inactive
27591
N/A
2013-10-30
II
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SINOPEP-ALLSINO BIOPH...
Active
33902
Complete
2021-01-15
2020-09-28
2020-03-26
II
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SINOPEP-ALLSINO BIOPH...
Active
37469
N/A
2022-09-01
II
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SINOPEP-ALLSINO BIOPH...
Active
29693
Complete
2016-12-21
2015-09-15
2016-08-16
II
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