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Bora CDMO Bora CDMO

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

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01 Beef Extract (1)

02 Bile Salts (1)

03 Cholic Acid (2)

04 Isoleucine (1)

05 N-Acetyl-D-Mannosamine (1)

06 Blank (1)

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01 Active (2)

02 Inactive (2)

03 Blank (3)

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01 Expired (1)

02 Valid (2)

03 Blank (4)

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01 Blank (7)

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01 Blank (7)

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2000-383 - Rev 05
Valid
Bile Acids and Derivatives, Cholic ...
2020-05-27
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Bile Acids and Derivatives, Cholic ...
Issue/Submission Date
2020-05-27
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USDMF

Found USDMF

27181
Active
CHOLIC ACID
2013-06-07
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
27181
Status
Active
Fees Unpaid
N/A
 
Filing Details
CHOLIC ACID
Issue/Submission Date
2013-06-07
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2013-347 - Rev 01
Valid
Bile powder, Standard and special b...
2023-07-17
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Bile powder, Standard and special b...
Issue/Submission Date
2023-07-17
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USDMF

Found USDMF

33683
Active
N-ACETYL-D-MANNOSAMINE MONOHYDRATE ...
2019-05-01
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
33683
Status
Active
Fees Unpaid
N/A
 
Filing Details
N-ACETYL-D-MANNOSAMINE MONOHYDRATE ...
Issue/Submission Date
2019-05-01
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USDMF

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CEP/COS

Caution CEP/COS

R0-CEP 2002-067 - Rev 01
Expired
Peptone 741HT
2005-03-08
Japanese DMF

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Written Confirmation

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Application Number
Status
Expired
 
Filing Details
Peptone 741HT
Issue/Submission Date
2005-03-08
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USDMF

Caution USDMF

8655
Inactive
SODIUM CHOLATE (INTERMEDIATE)
1990-07-12
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
8655
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SODIUM CHOLATE (INTERMEDIATE)
Issue/Submission Date
1990-07-12
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FACILITY AND OPERATING PROCEDURES IN LINTON, NEW ZEALAN...

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USDMF

Caution USDMF

8654
Inactive
FACILITY AND OPERATING PROCEDURES I...
1990-07-12
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
8654
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
FACILITY AND OPERATING PROCEDURES I...
Issue/Submission Date
1990-07-12
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