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Bora CDMO Bora CDMO

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Boai Nky Pharmaceuticals Ltd

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01 Crospovidone (1)

02 Polyvinylpyrrolidone/Vinyl Acetate Copolymer (1)

03 Povidone K12 (1)

04 Povidone K25 (1)

05 Povidone K30 (1)

06 Povidone K90 (1)

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01 Active (6)

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01 Valid (5)

02 Blank (1)

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01 Blank (6)

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01 Blank (6)

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USDMF

Found USDMF

35341
Active
CROSPOVIDONE
2020-12-24
CEP/COS

Found CEP/COS

R0-CEP 2023-020 - Rev 00
Valid
Crospovidone, Type A and B
2023-08-28
Japanese DMF

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Written Confirmation

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Application Number
35341
R0-CEP 2023-020 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
CROSPOVIDONE
Crospovidone, Type A and B
Issue/Submission Date
2020-12-24
2023-08-28
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USDMF

Found USDMF

36420
Active
COPOVIDONE
2021-11-23
CEP/COS

Found CEP/COS

R0-CEP 2023-019 - Rev 00
Valid
Copovidone, K-value: 25.2-30.8
2023-08-30
Japanese DMF

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Written Confirmation

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Application Number
36420
R0-CEP 2023-019 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
COPOVIDONE
Copovidone, K-value: 25.2-30.8
Issue/Submission Date
2021-11-23
2023-08-30
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USDMF

Found USDMF

36421
Active
POVIDONE K25
2021-12-01
CEP/COS

Found CEP/COS

R0-CEP 2022-423 - Rev 00
Valid
Povidone, K25
2023-06-09
Japanese DMF

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Written Confirmation

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Application Number
36421
R0-CEP 2022-423 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
POVIDONE K25
Povidone, K25
Issue/Submission Date
2021-12-01
2023-06-09
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USDMF

Found USDMF

35501
Active
POVIDONE K30
2021-02-05
CEP/COS

Found CEP/COS

R0-CEP 2021-327 - Rev 00
Valid
Povidone, K30
2022-04-13
Japanese DMF

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Written Confirmation

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Application Number
35501
R0-CEP 2021-327 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
POVIDONE K30
Povidone, K30
Issue/Submission Date
2021-02-05
2022-04-13
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USDMF

Found USDMF

36419
Active
POVIDONE K90
2021-12-13
CEP/COS

Found CEP/COS

R0-CEP 2023-040 - Rev 00
Valid
Povidone, K90
2023-06-23
Japanese DMF

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Written Confirmation

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Application Number
36419
R0-CEP 2023-040 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
POVIDONE K90
Povidone, K90
Issue/Submission Date
2021-12-13
2023-06-23
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USDMF

Found USDMF

37384
Active
POVIDONE K12
2022-09-22
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
37384
Status
Active
Fees Unpaid
N/A
 
Filing Details
POVIDONE K12
Issue/Submission Date
2022-09-22
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