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

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AGOMELATINE

ALISKIREN HEMIFUMARATE

ATORVASTATIN CALCIUM (TRIHYDRATE)

Atorvastatin calcium trihydrate

DOXYCYCLINE

DOXYCYCLINE HYCLATE

EZETIMIBE

Enalapril Maleate

FACILITY FOR THE MANUFACTURE OF METHACYCLINE

HYDROCHLOROTHIAZIDE

LCZ-9 (SACUBITRIL INTERMEDIATE)

LENALIDOMIDE

PREGABALIN

ROSUVASTATIN CALCIUM

RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE)

SOFOSBUVIR (AMORPHOUS)

TICAGRELOR

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Status - Inactive

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VALID

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AGOMELATINE
Issue/Submission Date
2013-03-08
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
AGOMELATINE
Issue/Submission Date
2013-03-08
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALISKIREN HEMIFUMARATE
Issue/Submission Date
2011-03-10
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
ALISKIREN HEMIFUMARATE
Issue/Submission Date
2011-03-10
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
Atorvastatin calcium trihydrate
Issue/Submission Date
2017-01-17
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
Atorvastatin calcium trihydrate
Issue/Submission Date
2017-01-17
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ATORVASTATIN CALCIUM (TRIHYDRATE)
Issue/Submission Date
2015-02-03
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
ATORVASTATIN CALCIUM (TRIHYDRATE)
Issue/Submission Date
2015-02-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DOXYCYCLINE
Issue/Submission Date
2005-11-09
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
DOXYCYCLINE
Issue/Submission Date
2005-11-09
Supporting Info
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USDMF

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

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USDMF

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

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
EZETIMIBE
Issue/Submission Date
2010-12-30
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
EZETIMIBE
Issue/Submission Date
2010-12-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
HYDROCHLOROTHIAZIDE
Issue/Submission Date
1983-04-29
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Hydrochlorothiazide
Issue/Submission Date
2018-02-16
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
VALID
 
Filing Details
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide
Issue/Submission Date
1983-04-29
2018-02-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
HYDROCHLOROTHIAZIDE
Issue/Submission Date
2003-08-08
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
HYDROCHLOROTHIAZIDE
Issue/Submission Date
2003-08-08
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
LENALIDOMIDE
Issue/Submission Date
2017-06-02
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
LENALIDOMIDE
Issue/Submission Date
2017-06-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PREGABALIN
Issue/Submission Date
2008-11-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pregabalin
Issue/Submission Date
2017-07-07
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
PREGABALIN
Pregabalin
Issue/Submission Date
2008-11-24
2017-07-07
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ROSUVASTATIN CALCIUM
Issue/Submission Date
2007-07-18
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Rosuvastatin calcium
Issue/Submission Date
2019-02-18
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
ROSUVASTATIN CALCIUM
Rosuvastatin calcium
Issue/Submission Date
2007-07-18
2019-02-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RSM (ROSUVASTATIN METHYL ESTER, ROS...
Issue/Submission Date
2009-10-29
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
RSM (ROSUVASTATIN METHYL ESTER, ROS...
Issue/Submission Date
2009-10-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
SOFOSBUVIR (AMORPHOUS)
Issue/Submission Date
2017-09-06
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
SOFOSBUVIR (AMORPHOUS)
Issue/Submission Date
2017-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TICAGRELOR
Issue/Submission Date
2015-01-14
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
TICAGRELOR
Issue/Submission Date
2015-01-14
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
FACILITY FOR THE MANUFACTURE OF MET...
Issue/Submission Date
1992-06-19
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
FACILITY FOR THE MANUFACTURE OF MET...
Issue/Submission Date
1992-06-19
Supporting Info

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LCZ-9 (SACUBITRIL INTERMEDIATE)
Issue/Submission Date
2019-01-23
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
LCZ-9 (SACUBITRIL INTERMEDIATE)
Issue/Submission Date
2019-01-23
Supporting Info

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