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

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01 CPG OLIGONUCLEOTIDE 1018 (1)

02 LENTIVIRAL VECTOR (1)

03 MC-VC-PAB-MMAE (1)

04 PAYLOAD-LINKER EXATECAN MESYLATE (1)

05 PAYLOAD-LINKER MC-MMAF (1)

06 PAYLOAD-LINKER VCMMAE (1)

07 WUXI ADHERENT HEK293T (WAHT) (1)

08 “MONOMETHYL AURISTATIN E (MMAE)” (1)

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01 CHANGZHOU SYNTHEALL PHARMACEUTICAL CO LTD (1)

02 SHANGHAI SYNTHEALL (STA) PHARMACEUTICAL CO LTD (2)

03 SHANGHAI SYNTHEALL PHARMACEUTICAL CO LTD (3)

04 WUXI APPTEC INC (2)

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01 China (8)

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01 Active (6)

02 Inactive (2)

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01 Complete (1)

02 Blank (7)

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SHANGHAI SYNTHEALL PH...
Active
37610
N/A
2023-06-07
II
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SHANGHAI SYNTHEALL (S...
Active
36725
N/A
2022-02-03
II
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SHANGHAI SYNTHEALL (S...
Active
36104
N/A
2021-07-22
II
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CPG OLIGONUCLEOTIDE 1018

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CHANGZHOU SYNTHEALL P...
Active
38490
N/A
2023-06-20
II
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LENTIVIRAL VECTOR

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WUXI APPTEC INC
Inactive
33124
N/A
2018-12-28
II
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MC-VC-PAB-MMAE

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SHANGHAI SYNTHEALL PH...
Active
38725
N/A
2023-08-16
II
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PAYLOAD-LINKER VCMMAE

URL Supplier Web Content
SHANGHAI SYNTHEALL PH...
Active
34821
Complete
2021-11-24
2021-04-14
2020-05-29
II
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WUXI ADHERENT HEK293T (WAHT)

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WUXI APPTEC INC
Inactive
32693
N/A
2019-01-02
II
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