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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apothecon Pharmaceuticals

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    Apothecon Pharmaceuticals
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    Country
    Country
    India
    Address
    Address
    Padra – Jambusar Highway, P.O. – Dabhasa, Pin – 391 440, Ta. Padra, Dist. Vadodara, Gujarat
    Telephone
    Telephone
    +91 2662244211
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    enquiries@pharmacompass.com
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    https://www.apotheconpharma.com/
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    Bendamustine Hydrochloride

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    USDMF

    Found USDMF

    27272
    Active
    BENDAMUSTINE HYDROCHLORIDE MONOHYDR...
    2013-09-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Bendamustine Hydrochloride Monohydr...
    2022-09-30
    Application Number
    27272
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    BENDAMUSTINE HYDROCHLORIDE MONOHYDR...
    Bendamustine Hydrochloride Monohydr...
    Issue/Submission Date
    2013-09-19
    2022-09-30
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    Carmustine

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    USDMF

    Found USDMF

    30492
    Active
    DS121 DRUG SUBTANCE
    2016-09-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Carmustine IH
    2022-09-30
    Application Number
    30492
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    DS121 DRUG SUBTANCE
    Carmustine IH
    Issue/Submission Date
    2016-09-06
    2022-09-30
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    Cyclophosphamide

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    USDMF

    Found USDMF

    35975
    Active
    CYCLOPHOSPHAMIDE USP (STERILE)
    2021-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Cyclophosphamide USP
    2022-09-30
    Application Number
    35975
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    CYCLOPHOSPHAMIDE USP (STERILE)
    Cyclophosphamide USP
    Issue/Submission Date
    2021-09-28
    2022-09-30
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    Melphalan Hydrochloride

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    USDMF

    Found USDMF

    29766
    Active
    MELPHALAN HYDROCHLORIDE
    2015-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Melphalan Hydrochloride IH
    2022-09-30
    Application Number
    29766
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    MELPHALAN HYDROCHLORIDE
    Melphalan Hydrochloride IH
    Issue/Submission Date
    2015-09-29
    2022-09-30
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    Ropivacaine Hydrochloride

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    USDMF

    Found USDMF

    19084
    Active
    ROPIVACAINE
    2005-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Ropivacaine Hydrochloride IH/Ropiva...
    2022-09-30
    Application Number
    19084
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-08
    Filing Details
    ROPIVACAINE
    Ropivacaine Hydrochloride IH/Ropiva...
    Issue/Submission Date
    2005-12-30
    2022-09-30
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    Sevelamer Carbonate

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    USDMF

    Found USDMF

    27405
    Active
    SEVELAMER CARBONATE
    2014-01-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Sevelamer Carbonate IH
    2022-09-30
    Application Number
    27405
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    SEVELAMER CARBONATE
    Sevelamer Carbonate IH
    Issue/Submission Date
    2014-01-02
    2022-09-30
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    Trientine Hydrochloride

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    USDMF

    Found USDMF

    30905
    Active
    TRIENTINE HYDROCHLORIDE USP
    2016-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Trientine Hydrochloride USP
    2022-09-30
    Application Number
    30905
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    TRIENTINE HYDROCHLORIDE USP
    Trientine Hydrochloride USP
    Issue/Submission Date
    2016-09-15
    2022-09-30
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    Vitamin K1

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    USDMF

    Found USDMF

    30910
    Active
    PHYTONADIONE USP (PROCESS A)
    2016-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0369
    Valid
    Vitamin K1 (Phytonadione) USP
    2022-09-30
    Application Number
    30910
    Indian CDSCO WC-0369
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-09-08
    Filing Details
    PHYTONADIONE USP (PROCESS A)
    Vitamin K1 (Phytonadione) USP
    Issue/Submission Date
    2016-09-20
    2022-09-30
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    Benztropine

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    USDMF

    Found USDMF

    32136
    Active
    BENZTROPINE MESYLATE USP
    2018-02-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32136
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BENZTROPINE MESYLATE USP
    Issue/Submission Date
    2018-02-09
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    Cyclophosphamide

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    USDMF

    Found USDMF

    38232
    Active
    CYCLOPHOSPHAMIDE USP
    2023-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38232
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CYCLOPHOSPHAMIDE USP
    Issue/Submission Date
    2023-03-31
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    Fomepizole

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    USDMF

    Found USDMF

    19683
    Active
    FOMEPIZOLE
    2006-08-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19683
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FOMEPIZOLE
    Issue/Submission Date
    2006-08-10
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    Fosaprepitant

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    USDMF

    Found USDMF

    33105
    Active
    FOSAPREPITANT DIMEGLUMINE
    2018-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33105
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FOSAPREPITANT DIMEGLUMINE
    Issue/Submission Date
    2018-09-27
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    Hydralazine Hydrochloride

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    USDMF

    Found USDMF

    19904
    Active
    HYDRALAZINE HYDROCHLORIDE USP
    2006-10-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19904
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE USP
    Issue/Submission Date
    2006-10-26
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    Hydralazine Hydrochloride

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    USDMF

    Found USDMF

    24321
    Active
    HYDRALAZINE HYDROCHLORIDE USP (P) G...
    2010-10-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24321
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE USP (P) G...
    Issue/Submission Date
    2010-10-28
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    Iron Sucrose

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18261
    Active
    IRON SUCROSE COMPLEX
    2005-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18261
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IRON SUCROSE COMPLEX
    Issue/Submission Date
    2005-04-11
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    Iron Sucrose

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    USDMF

    Found USDMF

    36918
    Active
    DS166 DRUG SUBSTANCE
    2022-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36918
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DS166 DRUG SUBSTANCE
    Issue/Submission Date
    2022-03-25
    ASK
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    Maraviroc

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36917
    Active
    MARAVIROC
    2022-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36917
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MARAVIROC
    Issue/Submission Date
    2022-03-30
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    Miglustat

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36453
    Active
    MIGLUSTAT
    2021-11-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36453
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIGLUSTAT
    Issue/Submission Date
    2021-11-10
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    Nicardipine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19773
    Active
    NICARDIPINE HYDROCHLORIDE USP
    2006-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19773
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NICARDIPINE HYDROCHLORIDE USP
    Issue/Submission Date
    2006-09-15
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    Penicillamine

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    USDMF

    Found USDMF

    33106
    Active
    PENICILLAMINE USP
    2018-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33106
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PENICILLAMINE USP
    Issue/Submission Date
    2018-09-28
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    Phenoxybenzamine HCl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31746
    Active
    PHENOXYBENZAMINE HYDROCHLORIDE USP
    2017-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31746
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PHENOXYBENZAMINE HYDROCHLORIDE USP
    Issue/Submission Date
    2017-12-28
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    Remifentanil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30156
    Active
    REMIFENTANIL HYDROCHLORIDE
    2016-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30156
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    REMIFENTANIL HYDROCHLORIDE
    Issue/Submission Date
    2016-09-27
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    Ropivacaine Hydrochloride

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    USDMF

    Found USDMF

    30152
    Active
    ROPIVACAINE HYDROCHLORIDE USP
    2016-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30152
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ROPIVACAINE HYDROCHLORIDE USP
    Issue/Submission Date
    2016-09-23
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    Sevelamer Hydrochloride

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    USDMF

    Found USDMF

    27908
    Active
    SEVELAMER HYDROCHLORIDE
    2014-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27908
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SEVELAMER HYDROCHLORIDE
    Issue/Submission Date
    2014-03-25
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    Sodium ferric gluconate

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    USDMF

    Found USDMF

    18541
    Active
    SODIUM FERRIC GLUCONATE COMPLEX
    2005-07-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18541
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM FERRIC GLUCONATE COMPLEX
    Issue/Submission Date
    2005-07-29
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    Sodium Nitroprusside

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    USDMF

    Found USDMF

    31164
    Active
    SODIUM NITROPRUSSIDE USP
    2017-06-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31164
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SODIUM NITROPRUSSIDE USP
    Issue/Submission Date
    2017-06-02
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    USDMF

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    20699
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    SODIUM 4-PHENYLBUTYRATE
    2007-07-18
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    Application Number
    20699
    Status
    Active
    Fees Paid
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    SODIUM 4-PHENYLBUTYRATE
    Issue/Submission Date
    2007-07-18
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    24498
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    TAUROLIDINE
    2010-12-28
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    Application Number
    24498
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    TAUROLIDINE
    Issue/Submission Date
    2010-12-28
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    DS108 DRUG SUBSTANCE

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    33132
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    DS108 DRUG SUBSTANCE
    2018-09-27
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    Application Number
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    Reviewed
     
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    DS108 DRUG SUBSTANCE
    Issue/Submission Date
    2018-09-27
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