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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Ckd Bio Corporation

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7-AMINOCEPHALOSPORANIC ACID, (7-ACA)

ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE

CLAVULANATE POTASSIUM

CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1

CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE

CYCLOSPORINE, NON-STERILE BULK, USP

DEMECLOCYCLINE HYDROCHLORIDE

LOVASTATIN, NON-STERILE BULK, USP

MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE

Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 1:1

Potassium clavulanate, diluted with microcrystalline cellulose in the ratio 7:3

RIFAMPIN

RIFAMYCIN O, NON-STERILE API

RIFAMYCIN SODIUM NON-STERILE BULK

RIFAMYCIN-S

TACROLIMUS NON STERILE API

Teicoplanin

Teicoplanin Process A

VANCOMYCIN HYDROCHLORIDE

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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220MF10038

223MF10162

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
7-AMINOCEPHALOSPORANIC ACID, (7-ACA...
Issue/Submission Date
1997-02-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
7-AMINOCEPHALOSPORANIC ACID, (7-ACA...
Issue/Submission Date
1997-02-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ACARBOSE, NON-STERILE BULK DRUG SUB...
Issue/Submission Date
2007-07-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Acarbose
Issue/Submission Date
2017-01-27
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Acarbose at 8, Chungjeong-ro, Seoda...
Issue/Submission Date
2008-02-05
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
ACARBOSE, NON-STERILE BULK DRUG SUB...
Acarbose
Acarbose at 8, Chungjeong-ro, Seoda...
Issue/Submission Date
2007-07-31
2017-01-27
2008-02-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLAVULANATE POTASSIUM
Issue/Submission Date
2003-01-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Potassium clavulanate
Issue/Submission Date
2017-01-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CLAVULANATE POTASSIUM
Potassium clavulanate
Issue/Submission Date
2003-01-21
2017-01-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLAVULANATE POTASSIUM WITH MICROCRY...
Issue/Submission Date
2005-04-14
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CLAVULANATE POTASSIUM WITH MICROCRY...
Issue/Submission Date
2005-04-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLAVULANATE POTASSIUM WITH SILICON ...
Issue/Submission Date
2005-04-14
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Potassium clavulanate, diluted with...
Issue/Submission Date
2017-01-18
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
CLAVULANATE POTASSIUM WITH SILICON ...
Potassium clavulanate, diluted with...
Issue/Submission Date
2005-04-14
2017-01-18
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Potassium clavulanate, diluted with...
Issue/Submission Date
2017-01-20
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Potassium clavulanate, diluted with...
Issue/Submission Date
2017-01-20
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Potassium clavulanate, diluted with...
Issue/Submission Date
2017-02-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Potassium clavulanate, diluted with...
Issue/Submission Date
2017-02-09
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CYCLOSPORINE, NON-STERILE BULK, USP
Issue/Submission Date
1996-10-25
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ciclosporin
Issue/Submission Date
2017-02-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
CYCLOSPORINE, NON-STERILE BULK, USP
Ciclosporin
Issue/Submission Date
1996-10-25
2017-02-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEMECLOCYCLINE HYDROCHLORIDE
Issue/Submission Date
1998-09-01
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Demeclocycline hydrochloride
Issue/Submission Date
2016-12-01
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
DEMECLOCYCLINE HYDROCHLORIDE
Demeclocycline hydrochloride
Issue/Submission Date
1998-09-01
2016-12-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LOVASTATIN, NON-STERILE BULK, USP
Issue/Submission Date
2000-05-04
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
LOVASTATIN, NON-STERILE BULK, USP
Issue/Submission Date
2000-05-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
MYCOPHENOLATE MOFETIL, NON-STERILE ...
Issue/Submission Date
2011-05-16
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
MYCOPHENOLATE MOFETIL, NON-STERILE ...
Issue/Submission Date
2011-05-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
RIFAMPIN
Issue/Submission Date
1998-09-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
RIFAMPIN
Issue/Submission Date
1998-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RIFAMYCIN O, NON-STERILE API
Issue/Submission Date
2012-06-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RIFAMYCIN O, NON-STERILE API
Issue/Submission Date
2012-06-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RIFAMYCIN SODIUM NON-STERILE BULK
Issue/Submission Date
2010-03-08
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Rifamycin sodium
Issue/Submission Date
2016-11-04
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
RIFAMYCIN SODIUM NON-STERILE BULK
Rifamycin sodium
Issue/Submission Date
2010-03-08
2016-11-04
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
RIFAMYCIN-S
Issue/Submission Date
1995-11-16
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RIFAMYCIN-S
Issue/Submission Date
1995-11-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
TACROLIMUS NON STERILE API
Issue/Submission Date
2016-10-21
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
TACROLIMUS NON STERILE API
Issue/Submission Date
2016-10-21
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Teicoplanin
Issue/Submission Date
2011-04-04
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
WITHDRAWN BY HOLDER
 
Filing Details
Teicoplanin
Issue/Submission Date
2011-04-04
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Teicoplanin Process A
Issue/Submission Date
2017-10-27
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Teicoplanin at 8, Chungjeong-ro, Se...
Issue/Submission Date
2011-11-14
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Teicoplanin Process A
Teicoplanin at 8, Chungjeong-ro, Se...
Issue/Submission Date
2017-10-27
2011-11-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
VANCOMYCIN HYDROCHLORIDE
Issue/Submission Date
2016-09-20
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
VANCOMYCIN HYDROCHLORIDE
Issue/Submission Date
2016-09-20
Supporting Info

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