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List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Astrazeneca to the Review Authority in Japan (PMDA). Original Data : PMDA

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01 1Media/Media Additives Tralokinumab Production Media in N-1 stage

02 1Media/Media Additives Tralokinumab Production Media in production stage

03 1Medium / Medium Additives / Ineviliumab Production Media

04 1Medium / Medium Additives Tralokinumab Inoculum Media

05 1Medium / Medium Additives Tralokinumab Production Media

06 1Medium / Medium Additives-Inebelizumb Production Media

07 1Medium / Medium Additives-Inebilizumab Inoculum Media

08 1Medium / Medium Additives-Inebilizumab Media

09 1Medium/Medium additive/Nilsevimab (genetical recombination) Medium additive A

10 1Medium/Medium additive/Nilsevimab (genetically recombinant) Medium additive B

11 1Medium/Medium additives/Nilsevimab (genetically recombinant) Inoculation medium

12 1Medium/Medium additives/Nilsevimab (genetically recombinant) production medium

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PharmaCompass

01

Discovery on Target
Not Confirmed
arrow

02

Discovery on Target
Not Confirmed
arrow

03

Discovery on Target
Not Confirmed
arrow

04

Media/Media Additives Tralokinumab Produ...

JDMF

Discovery on Target
Not Confirmed
arrow

Media/Media Additives Tralokinumab Produ...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 304MF40032

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2022-09-21

Latest Date of Registration : 2022-09-21

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05

Media/Media Additives Tralokinumab Produ...

JDMF

Discovery on Target
Not Confirmed
arrow

Media/Media Additives Tralokinumab Produ...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 304MF40033

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2022-09-21

Latest Date of Registration : 2022-09-21

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06

Medium / Medium Additives / Ineviliumab ...

JDMF

Discovery on Target
Not Confirmed
arrow

Medium / Medium Additives / Ineviliumab ...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 303MF40041

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2021-07-06

Latest Date of Registration : 2021-07-06

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07

Medium / Medium Additives Tralokinumab I...

JDMF

Discovery on Target
Not Confirmed
arrow

Medium / Medium Additives Tralokinumab I...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 303MF40060

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2021-09-02

Latest Date of Registration : 2021-09-02

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08

Medium / Medium Additives Tralokinumab P...

JDMF

Discovery on Target
Not Confirmed
arrow

Medium / Medium Additives Tralokinumab P...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 303MF40061

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2021-09-02

Latest Date of Registration : 2021-09-02

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09

Medium/Medium additive/Nilsevimab (genet...

JDMF

Discovery on Target
Not Confirmed
arrow

Medium/Medium additive/Nilsevimab (genet...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 305MF40039

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2023-11-15

Latest Date of Registration : 2023-11-15

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10

Medium/Medium additive/Nilsevimab (genet...

JDMF

Discovery on Target
Not Confirmed
arrow

Medium/Medium additive/Nilsevimab (genet...

arrow
Discovery on Target
Not Confirmed

AstraZeneca

Registration Number : 305MF40040

Registrant's Address : One MedImmune Way, Gaithersburg, MD 20878, USA

Initial Date of Registration : 2023-11-15

Latest Date of Registration : 2023-11-15

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