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    Poligon Industrial Els Vinyets-Els Fogars II 08777 Sant Quintí de Mediona, Barcelona
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    +34 93 819 13 99
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    • FDA
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    Calcitonin

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    USDMF

    Found USDMF

    19579
    Active
    SALMON CALCITONIN
    2006-07-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-226 - Rev 01
    Valid
    Calcitonin (salmon), Sterile - Synt...
    2009-02-09
    Japanese DMF

    Found JDMF

    223MF10073
    Elcatonin at Poligono industrial El...
    2011-05-27
    Written Confirmation

    Close WC

    Application Number
    19579
    R1-CEP 2001-226 - Rev 01
    223MF10073
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SALMON CALCITONIN
    Calcitonin (salmon), Sterile - Synt...
    Elcatonin at Poligono industrial El...
    Issue/Submission Date
    2006-07-05
    2009-02-09
    2011-05-27
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    • FDA
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    Leuprolide Acetate

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    USDMF

    Found USDMF

    26716
    Active
    LEUPROLIDE (LEUPRORELIN)
    2012-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-078 - Rev 04
    Valid
    Leuprorelin, sterile
    2017-04-19
    Japanese DMF

    Found JDMF

    302MF10043
    Leuprorelin Acetate at Poligono ind...
    2020-04-02
    Written Confirmation

    Close WC

    Application Number
    26716
    R1-CEP 2000-078 - Rev 04
    302MF10043
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEUPROLIDE (LEUPRORELIN)
    Leuprorelin, sterile
    Leuprorelin Acetate at Poligono ind...
    Issue/Submission Date
    2012-12-11
    2017-04-19
    2020-04-02
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    • FDA
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    Buserelin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-034 - Rev 02
    Valid
    Buserelin
    2015-12-21
    Japanese DMF

    Found JDMF

    305MF10126
    Buserelin at Poligono industrial El...
    2023-11-29
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-034 - Rev 02
    305MF10126
    Status
    Valid
     
    Filing Details
    Buserelin
    Buserelin at Poligono industrial El...
    Issue/Submission Date
    2015-12-21
    2023-11-29
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    • FDA
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    Desmopressin Acetate

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    USDMF

    Found USDMF

    19334
    Active
    DESMOPRESSIN ACETATE
    2006-04-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-058 - Rev 02
    Valid
    Desmopressin
    2008-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19334
    R1-CEP 2002-058 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DESMOPRESSIN ACETATE
    Desmopressin
    Issue/Submission Date
    2006-04-06
    2008-09-02
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    • FDA
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    Tetracosactide

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    USDMF

    Found USDMF

    18963
    Active
    TETRACOSACTIDE
    2005-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10242
    Tetracosactide at Poligono industri...
    2010-10-13
    Written Confirmation

    Close WC

    Application Number
    18963
    222MF10242
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TETRACOSACTIDE
    Tetracosactide at Poligono industri...
    Issue/Submission Date
    2005-11-18
    2010-10-13
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    • FDA
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    Angiotensin II

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    USDMF

    Found USDMF

    36370
    Active
    ANGIOTENSIN II
    2021-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36370
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ANGIOTENSIN II
    Issue/Submission Date
    2021-10-04
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    • FDA
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    Arginine Vasopressin

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    USDMF

    Found USDMF

    25736
    Active
    VASOPRESSIN
    2012-01-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25736
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VASOPRESSIN
    Issue/Submission Date
    2012-01-24
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    Cetrorelix Acetate

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    USDMF

    Found USDMF

    38264
    Active
    CETRORELIX
    2023-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38264
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CETRORELIX
    Issue/Submission Date
    2023-03-31
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    • FDA
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    Ganirelix

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    USDMF

    Found USDMF

    29585
    Active
    GANIRELIX ACETATE
    2015-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29585
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GANIRELIX ACETATE
    Issue/Submission Date
    2015-07-24
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    • FDA
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    Gonadorelin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10023
    Gonadorelin Diacetate at Poligono i...
    2023-02-08
    Written Confirmation

    Close WC

    Application Number
    305MF10023
    Status
     
    Filing Details
    Gonadorelin Diacetate at Poligono i...
    Issue/Submission Date
    2023-02-08
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    • FDA
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    Goserelin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-183 - Rev 01
    Valid
    Goserelin
    2014-06-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-183 - Rev 01
    Status
    Valid
     
    Filing Details
    Goserelin
    Issue/Submission Date
    2014-06-12
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    • FDA
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    Icatibant Acetate

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    USDMF

    Found USDMF

    29213
    Active
    ICATIBANT ACETATE
    2015-03-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29213
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ICATIBANT ACETATE
    Issue/Submission Date
    2015-03-26
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    • FDA
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    Lanreotide Acetate

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    USDMF

    Found USDMF

    39254
    Active
    LANREOTIDE
    2023-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39254
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LANREOTIDE
    Issue/Submission Date
    2023-12-21
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    • FDA
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    Leuprolide Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2017-193 - Rev 00
    Valid
    Leuprorelin
    2022-12-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2017-193 - Rev 00
    Status
    Valid
     
    Filing Details
    Leuprorelin
    Issue/Submission Date
    2022-12-16
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    • FDA
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    Natrecor

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26676
    Active
    NESIRITIDE
    2012-12-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26676
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NESIRITIDE
    Issue/Submission Date
    2012-12-04
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    • FDA
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    Octreotide Acetate

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    USDMF

    Found USDMF

    18740
    Active
    OCTREOTIDE ACETATE
    2005-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18740
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OCTREOTIDE ACETATE
    Issue/Submission Date
    2005-09-08
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    • FDA
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    Somatostatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1999-035 - Rev 03
    Valid
    Somatostatin
    2008-11-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1999-035 - Rev 03
    Status
    Valid
     
    Filing Details
    Somatostatin
    Issue/Submission Date
    2008-11-05
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    • FDA
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    Atosiban

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Carbetocin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Corticotropin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Exenatide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Glucagon

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Gonadorelin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Linaclotide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Lypressin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Pasireotide Diaspartate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Pramlintide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    • FDA
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    Secretin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    • FDA
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    Teriparatide Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    • FDA
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    Terlipressin Acetate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    • FDA
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    Thymalfasin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    Thyrotropin-Releasing Hormone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    • FDA
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    Triptorelin Pamoate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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    • FDA
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    Vapreotide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

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