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

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    • FDA
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    Cyclosporine

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    USDMF

    Found USDMF

    23962
    Active
    CYCLOSPORINE USP
    2010-07-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-214 - Rev 03
    Valid
    Ciclosporin
    2022-10-17
    Japanese DMF

    Found JDMF

    226MF10056
    Ciclosporin JP at 1482-1486, Trasad...
    2014-03-06
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Cyclosporine (USP/Ph. Eur.)
    2019-09-23
    Application Number
    23962
    R1-CEP 2010-214 - Rev 03
    226MF10056
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CYCLOSPORINE USP
    Ciclosporin
    Ciclosporin JP at 1482-1486, Trasad...
    Cyclosporine (USP/Ph. Eur.)
    Issue/Submission Date
    2010-07-08
    2022-10-17
    2014-03-06
    2019-09-23
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    • FDA
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    Everolimus

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    USDMF

    Found USDMF

    26350
    Active
    EVEROLIMUS USP (WITH 2% BHT)
    2013-06-14
    CEP/COS

    Found CEP/COS

    CEP 2022-106 - Rev 00
    Valid
    Everolimus, with 2% BHT
    2024-01-11
    Japanese DMF

    Found JDMF

    230MF10031
    Everolimus at 1482-1486, Trasad Roa...
    2018-02-19
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Everolimus
    2019-09-23
    Application Number
    26350
    CEP 2022-106 - Rev 00
    230MF10031
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    EVEROLIMUS USP (WITH 2% BHT)
    Everolimus, with 2% BHT
    Everolimus at 1482-1486, Trasad Roa...
    Everolimus
    Issue/Submission Date
    2013-06-14
    2024-01-11
    2018-02-19
    2019-09-23
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    • FDA
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    Mycophenolate Mofetil

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    USDMF

    Found USDMF

    19231
    Active
    MYCOPHENOLATE MOFETIL USP
    2006-03-07
    CEP/COS

    Found CEP/COS

    CEP 2009-361 - Rev 06
    Valid
    Mycophenolate mofetil
    2024-03-18
    Japanese DMF

    Found JDMF

    224MF10054
    Mycophenolate mofetil (production o...
    2012-03-12
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Mycophenolate Mofetil (EP/BP)
    2019-09-23
    Application Number
    19231
    CEP 2009-361 - Rev 06
    224MF10054
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MYCOPHENOLATE MOFETIL USP
    Mycophenolate mofetil
    Mycophenolate mofetil (production o...
    Mycophenolate Mofetil (EP/BP)
    Issue/Submission Date
    2006-03-07
    2024-03-18
    2012-03-12
    2019-09-23
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    • FDA
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    Tacrolimus

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    USDMF

    Found USDMF

    18908
    Active
    TACROLIMUS USP
    2005-10-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-216 - Rev 00
    Valid
    Tacrolimus monohydrate
    2020-06-02
    Japanese DMF

    Found JDMF

    222MF10197
    Tacrolimus hydrate (production only...
    2010-07-13
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Tacrolimus (USP)/Monohydrate EP/Pre...
    2019-09-23
    Application Number
    18908
    R0-CEP 2018-216 - Rev 00
    222MF10197
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TACROLIMUS USP
    Tacrolimus monohydrate
    Tacrolimus hydrate (production only...
    Tacrolimus (USP)/Monohydrate EP/Pre...
    Issue/Submission Date
    2005-10-24
    2020-06-02
    2010-07-13
    2019-09-23
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    • FDA
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    Lovastatin

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    USDMF

    Found USDMF

    17393
    Active
    LOVASTATIN USP
    2004-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-115 - Rev 03
    Valid
    Lovastatin
    2021-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Lovastatin (USP/Ph. Eur.)
    2019-09-23
    Application Number
    17393
    R1-CEP 2004-115 - Rev 03
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LOVASTATIN USP
    Lovastatin
    Lovastatin (USP/Ph. Eur.)
    Issue/Submission Date
    2004-05-17
    2021-05-17
    2019-09-23
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    • FDA
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    Mitomycin

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    USDMF

    Found USDMF

    33662
    Active
    MITOMYCIN USP
    2019-04-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-308 - Rev 00
    Valid
    Mitomycin
    2021-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Mitomycin EP/USP
    2019-09-23
    Application Number
    33662
    R0-CEP 2019-308 - Rev 00
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MITOMYCIN USP
    Mitomycin
    Mitomycin EP/USP
    Issue/Submission Date
    2019-04-20
    2021-02-25
    2019-09-23
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    • FDA
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    Mupirocin

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    USDMF

    Found USDMF

    28618
    Active
    MUPIROCIN USP
    2014-10-08
    CEP/COS

    Found CEP/COS

    CEP 2015-041 - Rev 01
    Valid
    Mupirocin
    2024-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Mupirocin (EP/USP)
    2019-09-23
    Application Number
    28618
    CEP 2015-041 - Rev 01
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MUPIROCIN USP
    Mupirocin
    Mupirocin (EP/USP)
    Issue/Submission Date
    2014-10-08
    2024-03-07
    2019-09-23
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    • FDA
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    Mupirocin Calcium

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    USDMF

    Found USDMF

    28907
    Active
    MUPIROCIN CALCIUM USP
    2015-01-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-119 - Rev 00
    Valid
    Mupirocin calcium
    2021-04-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Mupirocin Calcium EP/USP
    2019-09-23
    Application Number
    28907
    R1-CEP 2015-119 - Rev 00
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MUPIROCIN CALCIUM USP
    Mupirocin calcium
    Mupirocin Calcium EP/USP
    Issue/Submission Date
    2015-01-07
    2021-04-16
    2019-09-23
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    • FDA
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    Mycophenolate Sodium

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    USDMF

    Found USDMF

    21907
    Active
    MYCOPHENOLATE SODIUM USP
    2008-08-21
    CEP/COS

    Found CEP/COS

    CEP 2018-132 - Rev 01
    Valid
    Mycophenolate sodium
    2023-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Mycophenolate Sodium
    2019-09-23
    Application Number
    21907
    CEP 2018-132 - Rev 01
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    MYCOPHENOLATE SODIUM USP
    Mycophenolate sodium
    Mycophenolate Sodium
    Issue/Submission Date
    2008-08-21
    2023-11-17
    2019-09-23
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    Pravastatin

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    USDMF

    Found USDMF

    20727
    Active
    PRAVASTATIN SODIUM USP
    2007-08-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-018 - Rev 01
    Valid
    Pravastatin sodium
    2017-10-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Pravastatin Sodium (USP/EP)
    2019-09-23
    Application Number
    20727
    R1-CEP 2010-018 - Rev 01
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PRAVASTATIN SODIUM USP
    Pravastatin sodium
    Pravastatin Sodium (USP/EP)
    Issue/Submission Date
    2007-08-16
    2017-10-31
    2019-09-23
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    • FDA
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    Sirolimus

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    USDMF

    Found USDMF

    24468
    Active
    SIROLIMUS
    2011-02-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10039
    Sirolimus (for manufacturing only) ...
    2020-04-02
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Rapamycin (Sirolimus) IH
    2019-09-23
    Application Number
    24468
    302MF10039
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    SIROLIMUS
    Sirolimus (for manufacturing only) ...
    Rapamycin (Sirolimus) IH
    Issue/Submission Date
    2011-02-24
    2020-04-02
    2019-09-23
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    • FDA
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    Vancomycin Hydrochloride

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    USDMF

    Found USDMF

    22528
    Active
    VANCOMYCIN HYDROCHLORIDE USP
    2009-02-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-120 - Rev 01
    Valid
    Vancomycin hydrochloride
    2019-11-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Vancomycin HCL (USP/EP)
    2019-09-23
    Application Number
    22528
    R1-CEP 2010-120 - Rev 01
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    VANCOMYCIN HYDROCHLORIDE USP
    Vancomycin hydrochloride
    Vancomycin HCL (USP/EP)
    Issue/Submission Date
    2009-02-10
    2019-11-19
    2019-09-23
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    • FDA
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    Tacrolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34491
    Active
    TACROLIMUS USP (PROCESS II)
    2020-01-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-227 - Rev 01
    Valid
    Tacrolimus monohydrate, Process II
    2022-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34491
    R0-CEP 2020-227 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TACROLIMUS USP (PROCESS II)
    Tacrolimus monohydrate, Process II
    Issue/Submission Date
    2020-01-16
    2022-12-19
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    • FDA
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    Dactinomycin

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    USDMF

    Found USDMF

    34247
    Active
    DACTINOMYCIN USP
    2019-11-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Dactinomycin USP
    2019-09-23
    Application Number
    34247
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    DACTINOMYCIN USP
    Dactinomycin USP
    Issue/Submission Date
    2019-11-06
    2019-09-23
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    • FDA
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    Midostaurin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34976
    Active
    MIDOSTAURIN
    2020-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111A3
    Expired
    Midostaurin IH
    2022-05-27
    Application Number
    34976
    Indian CDSCO WC-0111A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    MIDOSTAURIN
    Midostaurin IH
    Issue/Submission Date
    2020-10-27
    2022-05-27
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    • FDA
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    Mycophenolate Mofetil

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    29553
    Active
    MYCOPHENOLATE MOFETIL USP (BY AZEOT...
    2015-09-04
    CEP/COS

    Caution CEP/COS

    R0-CEP 2020-050 - Rev 01
    Withdrawn by Holder
    Mycophenolate mofetil, Source II
    2022-03-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29553
    R0-CEP 2020-050 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    MYCOPHENOLATE MOFETIL USP (BY AZEOT...
    Mycophenolate mofetil, Source II
    Issue/Submission Date
    2015-09-04
    2022-03-09
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    Pimecrolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29658
    Active
    PIMECROLIMUS
    2015-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Pimecrolimus IH
    2019-09-23
    Application Number
    29658
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    PIMECROLIMUS
    Pimecrolimus IH
    Issue/Submission Date
    2015-09-15
    2019-09-23
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    Romidepsin

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    USDMF

    Found USDMF

    27399
    Active
    ROMIDEPSIN
    2013-11-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Romidepsin IH
    2019-09-23
    Application Number
    27399
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ROMIDEPSIN
    Romidepsin IH
    Issue/Submission Date
    2013-11-01
    2019-09-23
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    Temsirolimus

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    USDMF

    Found USDMF

    24921
    Active
    TEMSIROLIMUS
    2011-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0111
    Expired
    Temsirolimus
    2019-09-23
    Application Number
    24921
    Indian CDSCO WC-0111
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    TEMSIROLIMUS
    Temsirolimus
    Issue/Submission Date
    2011-05-28
    2019-09-23
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    Mycophenolate Sodium

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-278 - Rev 02
    Valid
    Mycophenolate sodium, Source II
    2022-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-278 - Rev 02
    Status
    Valid
     
    Filing Details
    Mycophenolate sodium, Source II
    Issue/Submission Date
    2022-03-15
    ASK
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    • FDA
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    Mycophenolic Acid

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2018-157 - Rev 02
    Valid
    Mycophenolate mofetil, By azeotropi...
    2024-02-09
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    CEP 2018-157 - Rev 02
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    Valid
     
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    Mycophenolate mofetil, By azeotropi...
    Issue/Submission Date
    2024-02-09
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    35435
    Active
    STAUROSPORINE TECHNICAL
    2020-12-11
    CEP/COS

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    Application Number
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    Fees Paid
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    STAUROSPORINE TECHNICAL
    Issue/Submission Date
    2020-12-11
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    Indian CDSCO WC-0111
    Expired
    Anidulafungin IH
    2019-09-23
    Application Number
    Indian CDSCO WC-0111
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    Expired
    2022-07-02
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    Issue/Submission Date
    2019-09-23
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    Expired
    Milbemycin Oxime IH
    2019-09-23
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    Expired
    2022-07-02
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    R0-CEP 2005-290 - Rev 01
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    Simvastatin
    2009-10-05
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    Indian CDSCO WC-0111
    Expired
    Teicoplanin EP
    2019-09-23
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