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Renejix CDMO Partner for Small Molecule Oral Dosage Forms Renejix CDMO Partner for Small Molecule Oral Dosage Forms

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Dongkook Pharmaceutical

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01 Gadoteridol (1)

02 Iopamidol (1)

03 Propofol (2)

04 Streptokinase (1)

05 Teicoplanin (1)

06 Voriconazole (1)

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01 Blank (7)

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01 Expired (1)

02 Valid (1)

03 Blank (5)

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01 217MF10576 (1)

02 219MF10087 (1)

03 219MF10354 (1)

04 223MF10043 (1)

05 225MF10175 (1)

06 Blank (2)

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01 Blank (7)

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2009-335 - Rev 04
Valid
Teicoplanin
2022-10-19
Japanese DMF

Found JDMF

219MF10354
Teicoplanin at 7, Teheran-ro 108-gi...
2007-12-13
Written Confirmation

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Application Number
219MF10354
Status
Valid
 
Filing Details
Teicoplanin
Teicoplanin at 7, Teheran-ro 108-gi...
Issue/Submission Date
2022-10-19
2007-12-13
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USDMF

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CEP/COS

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Japanese DMF

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225MF10175
Gadoteridol at 4F, 16, Teheran-ro 1...
2013-09-10
Written Confirmation

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Application Number
225MF10175
Status
 
Filing Details
Gadoteridol at 4F, 16, Teheran-ro 1...
Issue/Submission Date
2013-09-10
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USDMF

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CEP/COS

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Japanese DMF

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217MF10576
Iopamidol at 7, Teheran-ro 108-gil,...
2005-09-14
Written Confirmation

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Application Number
217MF10576
Status
 
Filing Details
Iopamidol at 7, Teheran-ro 108-gil,...
Issue/Submission Date
2005-09-14
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USDMF

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CEP/COS

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Japanese DMF

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219MF10087
Propofol at #997-8, Daechi-3 Dong, ...
2007-03-14
Written Confirmation

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Application Number
219MF10087
Status
 
Filing Details
Propofol at #997-8, Daechi-3 Dong, ...
Issue/Submission Date
2007-03-14
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USDMF

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CEP/COS

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Japanese DMF

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223MF10043
Propofol at 715, Yeongdong-daero, G...
2011-03-11
Written Confirmation

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Application Number
223MF10043
Status
 
Filing Details
Propofol at 715, Yeongdong-daero, G...
Issue/Submission Date
2011-03-11
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USDMF

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CEP/COS

Caution CEP/COS

R0-CEP 2013-008 - Rev 00
Expired
Voriconazole
2015-06-08
Japanese DMF

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Application Number
Status
Expired
 
Filing Details
Voriconazole
Issue/Submission Date
2015-06-08
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
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