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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Sandoz B2B by EDQM. Original Data: EDQM Database

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    Sandoz B2B
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    +41 613241111
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    Amlodipine besilate

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R1-CEP 2004-210 - Rev 00
    Chemical
    2011-07-01
    2016-01-14
    1491
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    Amoxicillin sodium, Sterile

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    SANDOZ GMBH Kundl AT
    Valid
    CEP 1998-058 - Rev 07
    Chemical
    2024-03-13
    577
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    Amoxicillin sodium, Sterile, process E

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    Sandoz Industrial Produ...
    Valid
    R1-CEP 1999-036 - Rev 09
    Chemical
    2022-09-09
    577
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    Amoxicillin trihydrate, For veterinary purposes only, s...

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    SANDOZ GMBH Kundl AT
    Withdrawn by Holder
    R0-CEP 2007-018 - Rev 02
    Chemical
    2013-05-28
    2014-09-08
    260
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    Amoxicillin trihydrate, Material codes 472191, 472188, ...

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    Sandoz Industrial Produ...
    Valid
    R2-CEP 1995-034 - Rev 06
    Chemical
    2015-11-12
    260
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    Amoxicillin trihydrate, Powder and for Direct Compressi...

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    SANDOZ GMBH Kundl AT
    Valid
    CEP 2023-277 - Rev 00
    Chemical
    2023-09-18
    260
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    Ampicillin sodium, Sterile

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    SANDOZ GMBH Kundl AT
    Valid
    CEP 1993-005 - Rev 08
    Chemical
    2024-02-20
    578
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    Ampicillin trihydrate, Powder and compacted

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    Sandoz Industrial Produ...
    Valid
    R2-CEP 1995-035 - Rev 05
    Chemical
    2020-02-17
    168
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    Ampicillin, Powder, compacted

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    Sandoz Industrial Produ...
    Valid
    R1-CEP 1999-188 - Rev 03
    Chemical
    2018-01-15
    167
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    Azithromycin, Monohydrate

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    SANDOZ INDUSTRIAL PRODU...
    Withdrawn by Holder
    R1-CEP 2002-257 - Rev 01
    Chemical
    2012-09-26
    2023-07-20
    1649
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    Benzylpenicillin (benzathine) tetrahydrate, Sterile, mi...

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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2001-066 - Rev 05
    Chemical
    2023-07-26
    373
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    Benzylpenicillin (benzathine) tetrahydrate, ‘ FA Proc...

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    SANDOZ GMBH Kundl AT
    Withdrawn by Holder
    R1-CEP 1994-018 - Rev 04
    Chemical
    2004-12-01
    2005-05-13
    373
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    Benzylpenicillin (procaine) monohydrate, Lecithin coate...

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    SANDOZ GMBH Kundl AT
    Valid
    CEP 1999-017 - Rev 05
    Chemical
    2023-09-22
    115
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    Benzylpenicillin (procaine) monohydrate, Sterile, micro...

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    SANDOZ GMBH Kundl AT
    Valid
    R2-CEP 1995-003 - Rev 04
    Chemical
    2019-12-05
    115
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    Benzylpenicillin potassium, Sterile

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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2001-395 - Rev 03
    Chemical
    2019-11-20
    113
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    Benzylpenicillin sodium, Sterile

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    SANDOZ GMBH Kundl AT
    Valid
    CEP 1992-017 - Rev 08
    Chemical
    2023-09-27
    114
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    Cefazolin sodium, Sterile

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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 1999-074 - Rev 09
    Chemical
    2016-07-28
    988
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    Cefepime dihydrochloride monohydrate, Sterile

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    SANDOZ GMBH Kundl AT
    Withdrawn by Holder
    R1-CEP 2008-212 - Rev 01
    Chemical
    2018-02-23
    2020-09-08
    2126
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    Cefixime

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    SANDOZ PRIVATE LIMITED ...
    Withdrawn by Holder
    R1-CEP 2001-449 - Rev 00
    Chemical
    2008-05-14
    2018-08-16
    1188
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    Cefixime

    PDF Supplier PDF
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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2009-347 - Rev 02
    Chemical
    2018-10-31
    1188
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    Cefixime, Alternative process

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    SANDOZ PRIVATE LIMITED ...
    Withdrawn by Holder
    R0-CEP 2010-192 - Rev 00
    Chemical
    2014-01-08
    2018-08-16
    1188
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    Cefotaxime sodium, Sterile

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    SANDOZ GMBH Kundl AT
    Withdrawn by Holder
    R1-CEP 2002-148 - Rev 03
    Chemical
    2018-02-15
    2024-02-21
    989
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    Cefotaxime sodium, Sterile

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    SANDOZ GMBH Kundl AT
    Withdrawn by Holder
    R1-CEP 2000-047 - Rev 03
    Chemical
    2012-10-16
    2016-05-11
    989
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    • FDA
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    Cefpodoxime proxetil

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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2010-283 - Rev 01
    Chemical
    2017-12-05
    2341
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    Cefpodoxime proxetil, Turbhe site

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    SANDOZ PRIVATE LIMITED ...
    Withdrawn by Holder
    R0-CEP 2013-064 - Rev 00
    Chemical
    2013-09-30
    2018-07-24
    2341
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    • FDA
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    Ceftazidime pentahydrate with sodium carbonate for inje...

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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2010-272 - Rev 01
    Chemical
    2019-05-03
    2344
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    Ceftazidime Pentahydrate, Sterile

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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2001-252 - Rev 04
    Chemical
    2015-06-15
    1405
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    Ceftriaxone sodium, Sterile

    PDF Supplier PDF
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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 1999-192 - Rev 05
    Chemical
    2018-02-16
    991
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    Ceftriaxone sodium, Sterile

    PDF Supplier PDF
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    SANDOZ GMBH Kundl AT
    Valid
    R1-CEP 2004-137 - Rev 04
    Chemical
    2016-09-02
    991
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    Cefuroxime axetil, Amorphous

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    SANDOZ PRIVATE LIMITED ...
    Withdrawn by Holder
    R1-CEP 2002-131 - Rev 00
    Chemical
    2009-01-29
    2018-10-08
    1300
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    • FDA
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    Clarithromycin, Powder and microfine

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    Sandoz Industrial Produ...
    Withdrawn by Holder
    R1-CEP 2003-044 - Rev 01
    Chemical
    2012-08-31
    2023-09-11
    1651
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    Cloxacillin sodium, Powder, Compacted

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    Sandoz Industrial Produ...
    Valid
    R2-CEP 1995-036 - Rev 05
    Chemical
    2019-11-18
    661
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    Cloxacillin sodium, Sterile

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    SANDOZ INDUSTRIAL PRODU...
    Withdrawn by Holder
    R1-CEP 2001-233 - Rev 03
    Chemical
    2013-11-29
    2018-07-06
    661
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    • FDA
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    Dicloxacillin sodium, Powder and compacted

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    Sandoz Industrial Produ...
    Valid
    R1-CEP 1996-023 - Rev 04
    Chemical
    2016-07-25
    663
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    • FDA
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    Erythromycin ethylsuccinate, Pulverised

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    Sandoz Industrial Produ...
    Withdrawn by Holder
    R1-CEP 1998-046 - Rev 01
    Chemical
    2006-05-24
    2011-09-05
    274
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    Erythromycin, Code number 4365000

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    Sandoz Industrial Produ...
    Withdrawn by Holder
    R1-CEP 1998-042 - Rev 02
    Chemical
    2008-12-18
    2011-09-05
    179
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    Erythromycin, code number 4384000

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    Sandoz Industrial Produ...
    Withdrawn by Holder
    R1-CEP 1999-082 - Rev 02
    Chemical
    2006-05-24
    2011-09-05
    179
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    Esomeprazole magnesium dihydrate

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    Sandoz Syntek Ilaç Ham...
    Valid
    R1-CEP 2015-032 - Rev 00
    Chemical
    2021-04-28
    2787
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    • FDA
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    Flucloxacillin sodium monohydrate, Ethyl acetate proces...

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    SANDOZ INDUSTRIAL PRODU...
    Withdrawn by Holder
    R1-CEP 1999-077 - Rev 03
    Chemical
    2019-03-28
    2023-03-22
    668
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    • FDA
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    Gentamicin sulfate

    PDF Supplier PDF
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    LEK PHARMACEUTICALS D.D...
    Valid
    R1-CEP 2005-121 - Rev 01
    Chemical
    2016-02-03
    331
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    Imipenem monohydrate, Chemical synthesis, Sterile

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    SANDOZ PRIVATE LIMITED ...
    Withdrawn by Holder
    R0-CEP 2010-170 - Rev 00
    Chemical
    2012-06-12
    2013-04-05
    1226
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    Lansoprazole

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    SANDOZ PRIVATE LIMITED ...
    Withdrawn by Holder
    R1-CEP 2011-107 - Rev 00
    Chemical
    2017-09-05
    2023-07-19
    2219
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    Levothyroxine sodium, Code 460 187 - Code 460 132

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    SANDOZ GMBH Kundl AT
    Valid
    CEP 1998-141 - Rev 11
    Chemical
    2023-09-26
    401
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    Liothyronine sodium

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    SANDOZ GMBH Kundl AT
    Withdrawn by Holder
    R1-CEP 2001-043 - Rev 02
    Chemical
    2008-07-22
    2022-11-30
    728
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    Lisinopril dihydrate

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R0-CEP 2006-065 - Rev 00
    Chemical
    2008-08-12
    2012-12-13
    1120
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    Lovastatin

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R0-CEP 2005-140 - Rev 00
    Chemical
    2007-12-07
    2010-02-02
    1538
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    Mycophenolate mofetil

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R1-CEP 2005-222 - Rev 02
    Chemical
    2016-10-13
    2018-04-03
    1700
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    Mycophenolate mofetil, Process B

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    LEK PHARMACEUTICALS D.D...
    Valid
    R1-CEP 2011-317 - Rev 05
    Chemical
    2023-08-07
    1700
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    Omeprazole

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    Sandoz Syntek Ilaç Ham...
    Valid
    R1-CEP 2004-025 - Rev 04
    Chemical
    2018-06-04
    942
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    Omeprazole

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    LEK PHARMACEUTICALS D.D...
    Withdrawn by Holder
    R1-CEP 2004-101 - Rev 02
    Chemical
    2013-04-18
    2015-06-09
    942
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