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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

LENALIDOMIDE

PREGABALIN

ROSUVASTATIN CALCIUM

RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE)

SOFOSBUVIR (AMORPHOUS)

TICAGRELOR

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Status - Active

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
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
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
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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