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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Concord Biotech Limited

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CYCLOSPORINE USP

EVEROLIMUS

LOVASTATIN USP

MUPIROCIN CALCIUM USP

MUPIROCIN USP

MYCOPHENOLATE MOFETIL USP

MYCOPHENOLATE MOFETIL USP (BY AZEOTROPIC DISTILLATION)

MYCOPHENOLATE SODIUM USP

PIMECROLIMUS

PRAVASTATIN SODIUM USP

ROMIDEPSIN

SIMVASTATIN USP

SIROLIMUS

TACROLIMUS USP

TEMSIROLIMUS

Tacrolimus (USP)

VANCOMYCIN HYDROCHLORIDE USP

Vancomycin HCL (USP/EP)

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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222MF10197

224MF10054

226MF10056

230MF10031

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WC-0111

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CYCLOSPORINE USP
Issue/Submission Date
2010-07-08
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Ciclosporin
Issue/Submission Date
2017-10-31
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Ciclosporin JP at 1482-1486, Trasad...
Issue/Submission Date
2014-03-06
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Cyclosporine (USP/Ph. Eur.)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CYCLOSPORINE USP
Ciclosporin
Ciclosporin JP at 1482-1486, Trasad...
Cyclosporine (USP/Ph. Eur.)
Issue/Submission Date
2010-07-08
2017-10-31
2014-03-06
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
EVEROLIMUS
Issue/Submission Date
2013-06-14
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Everolimus at 1482-1486, Trasad Roa...
Issue/Submission Date
2018-02-19
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Everolimus
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
EVEROLIMUS
Everolimus at 1482-1486, Trasad Roa...
Everolimus
Issue/Submission Date
2013-06-14
2018-02-19
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LOVASTATIN USP
Issue/Submission Date
2004-05-17
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Lovastatin
Issue/Submission Date
2017-10-31
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Lovastatin (USP/Ph. Eur.)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
LOVASTATIN USP
Lovastatin
Lovastatin (USP/Ph. Eur.)
Issue/Submission Date
2004-05-17
2017-10-31
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MUPIROCIN USP
Issue/Submission Date
2014-10-08
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mupirocin
Issue/Submission Date
2018-11-12
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Mupirocin (EP/USP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
MUPIROCIN USP
Mupirocin
Mupirocin (EP/USP)
Issue/Submission Date
2014-10-08
2018-11-12
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MUPIROCIN CALCIUM USP
Issue/Submission Date
2015-01-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mupirocin calcium
Issue/Submission Date
2017-10-31
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
MUPIROCIN CALCIUM USP
Mupirocin calcium
Issue/Submission Date
2015-01-07
2017-10-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MYCOPHENOLATE MOFETIL USP
Issue/Submission Date
2006-03-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Mycophenolate mofetil
Issue/Submission Date
2017-10-31
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Mycophenolate mofetil (production o...
Issue/Submission Date
2012-03-12
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Mycophenolate Mofetil (EP/BP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
MYCOPHENOLATE MOFETIL USP
Mycophenolate mofetil
Mycophenolate mofetil (production o...
Mycophenolate Mofetil (EP/BP)
Issue/Submission Date
2006-03-07
2017-10-31
2012-03-12
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MYCOPHENOLATE MOFETIL USP (BY AZEOT...
Issue/Submission Date
2015-09-04
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
MYCOPHENOLATE MOFETIL USP (BY AZEOT...
Issue/Submission Date
2015-09-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
MYCOPHENOLATE SODIUM USP
Issue/Submission Date
2008-08-21
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
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Mycophenolate Sodium
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
MYCOPHENOLATE SODIUM USP
Mycophenolate Sodium
Issue/Submission Date
2008-08-21
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
PIMECROLIMUS
Issue/Submission Date
2015-09-15
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 - Complete
 
Filing Details
PIMECROLIMUS
Issue/Submission Date
2015-09-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
PRAVASTATIN SODIUM USP
Issue/Submission Date
2007-08-16
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Pravastatin sodium
Issue/Submission Date
2017-10-31
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Pravastatin Sodium (USP/EP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
PRAVASTATIN SODIUM USP
Pravastatin sodium
Pravastatin Sodium (USP/EP)
Issue/Submission Date
2007-08-16
2017-10-31
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ROMIDEPSIN
Issue/Submission Date
2013-11-01
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
ROMIDEPSIN
Issue/Submission Date
2013-11-01
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
SIMVASTATIN USP
Issue/Submission Date
2005-12-13
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY HOLDER
Filing Details
Simvastatin
Issue/Submission Date
2009-10-05
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
WITHDRAWN BY HOLDER
 
Filing Details
SIMVASTATIN USP
Simvastatin
Issue/Submission Date
2005-12-13
2009-10-05
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
SIROLIMUS
Issue/Submission Date
2011-02-24
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
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Sirolimus
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
SIROLIMUS
Sirolimus
Issue/Submission Date
2011-02-24
2016-10-26
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
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Tacrolimus (USP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
 
Valid - 2019-07-02
Filing Details
Tacrolimus (USP)
Issue/Submission Date
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TACROLIMUS USP
Issue/Submission Date
2005-10-24
Supporting Info
CEP/COS

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

Application Number
Status
 
Filing Details
Tacrolimus hydrate (production only...
Issue/Submission Date
2010-07-13
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
TACROLIMUS USP
Tacrolimus hydrate (production only...
Issue/Submission Date
2005-10-24
2010-07-13
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TEMSIROLIMUS
Issue/Submission Date
2011-05-28
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
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Temsirolimus
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
TEMSIROLIMUS
Temsirolimus
Issue/Submission Date
2011-05-28
2016-10-26
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
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

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

Application Number
Indian CDSCO WC-0111
Status
Valid - 2019-07-02
Filing Details
Vancomycin HCL (USP/EP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0111
Status
 
Valid - 2019-07-02
Filing Details
Vancomycin HCL (USP/EP)
Issue/Submission Date
2016-10-26
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
VANCOMYCIN HYDROCHLORIDE USP
Issue/Submission Date
2009-02-10
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Vancomycin hydrochloride
Issue/Submission Date
2017-10-31
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
VANCOMYCIN HYDROCHLORIDE USP
Vancomycin hydrochloride
Issue/Submission Date
2009-02-10
2017-10-31
Supporting Info

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