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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Mac-Chem Products (India) Pvt.Ltd

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    MAC-CHEM PRODUCTS (INDIA) PVT.LTD

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    Mac-Chem Products (India) Pvt.Ltd
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    304, Town Centre, 3rd Floor, Andheri (East), Mumbai 400059
    Telephone
    Telephone
    91 22 4093 9000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.macchemgroup.com/
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    • FDA
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    Bicalutamide

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    USDMF

    Found USDMF

    26355
    Active
    BICALUTAMIDE USP
    2012-08-27
    CEP/COS

    Caution CEP/COS

    R0-CEP 2019-329 - Rev 00
    Suspended by EDQM GMP non-compliance
    Bicalutamide
    2021-06-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Bicalutamide USP/IP
    2021-01-22
    Application Number
    26355
    R0-CEP 2019-329 - Rev 00
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide
    Bicalutamide USP/IP
    Issue/Submission Date
    2012-08-27
    2021-06-11
    2021-01-22
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27026
    Active
    CAPECITABINE
    2013-04-02
    CEP/COS

    Caution CEP/COS

    R0-CEP 2020-187 - Rev 00
    Withdrawn by Holder
    Capecitabine
    2022-06-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Capecitabine(USP)
    2021-01-22
    Application Number
    27026
    R0-CEP 2020-187 - Rev 00
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Expired
    2023-08-01
    Filing Details
    CAPECITABINE
    Capecitabine
    Capecitabine(USP)
    Issue/Submission Date
    2013-04-02
    2022-06-15
    2021-01-22
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    • FDA
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    Carboplatin

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    USDMF

    Found USDMF

    26029
    Active
    CARBOPLATIN USP
    2012-05-08
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-147 - Rev 01
    Withdrawn by Holder
    Carboplatin
    2019-09-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Carboplatin (BP/USP)
    2021-01-22
    Application Number
    26029
    R1-CEP 2012-147 - Rev 01
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Expired
    2023-08-01
    Filing Details
    CARBOPLATIN USP
    Carboplatin
    Carboplatin (BP/USP)
    Issue/Submission Date
    2012-05-08
    2019-09-12
    2021-01-22
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    • FDA
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    Cytarabine

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    USDMF

    Found USDMF

    26281
    Active
    CYTARABINE USP
    2012-05-24
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-251 - Rev 01
    Suspended by EDQM GMP non-compliance
    Cytarabine
    2022-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Cytarabine
    2021-01-22
    Application Number
    26281
    R1-CEP 2012-251 - Rev 01
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    CYTARABINE USP
    Cytarabine
    Cytarabine
    Issue/Submission Date
    2012-05-24
    2022-05-19
    2021-01-22
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    • FDA
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    Dacarbazine

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    USDMF

    Found USDMF

    25624
    Active
    DACARBAZINE USP
    2011-12-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-066 - Rev 00
    Withdrawn by Holder
    Dacarbazine
    2018-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Decarbazine USP/BP/EP
    2021-01-22
    Application Number
    25624
    R1-CEP 2012-066 - Rev 00
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Expired
    2023-08-01
    Filing Details
    DACARBAZINE USP
    Dacarbazine
    Decarbazine USP/BP/EP
    Issue/Submission Date
    2011-12-27
    2018-02-07
    2021-01-22
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    • FDA
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    Irinotecan Hydrochloride

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    USDMF

    Found USDMF

    26554
    Active
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
    2012-09-14
    CEP/COS

    Caution CEP/COS

    R0-CEP 2018-063 - Rev 00
    Suspended by EDQM GMP non-compliance
    Irinotecan hydrochloride trihydrate
    2020-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Irinotecan Hydrochloride
    2021-01-22
    Application Number
    26554
    R0-CEP 2018-063 - Rev 00
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
    Irinotecan hydrochloride trihydrate
    Irinotecan Hydrochloride
    Issue/Submission Date
    2012-09-14
    2020-01-17
    2021-01-22
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    • FDA
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    Letrozole

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    USDMF

    Found USDMF

    26550
    Active
    LETROZOLE USP
    2012-09-14
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-350 - Rev 02
    Withdrawn by Holder
    Letrozole
    2022-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Letrozole
    2021-01-22
    Application Number
    26550
    R1-CEP 2012-350 - Rev 02
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Expired
    2023-08-01
    Filing Details
    LETROZOLE USP
    Letrozole
    Letrozole
    Issue/Submission Date
    2012-09-14
    2022-06-22
    2021-01-22
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    Ropivacaine Hydrochloride

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    USDMF

    Found USDMF

    27027
    Active
    ROPIVACAINE HYDROCHLORIDE MONOHYDRA...
    2013-04-02
    CEP/COS

    Caution CEP/COS

    R0-CEP 2017-246 - Rev 01
    Suspended by EDQM GMP non-compliance
    Ropivacaine hydrochloride monohydra...
    2021-03-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Ropivacaine HCl
    2021-01-22
    Application Number
    27027
    R0-CEP 2017-246 - Rev 01
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    ROPIVACAINE HYDROCHLORIDE MONOHYDRA...
    Ropivacaine hydrochloride monohydra...
    Ropivacaine HCl
    Issue/Submission Date
    2013-04-02
    2021-03-23
    2021-01-22
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    • FDA
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    Succinylcholine Chloride

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    USDMF

    Found USDMF

    25440
    Active
    SUCCINYLCHOLINE CHLORIDE USP
    2011-10-31
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-025 - Rev 02
    Suspended by EDQM GMP non-compliance
    Suxamethonium Chloride
    2021-05-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Succinylcholine Chloride (BP/USP)
    2021-01-22
    Application Number
    25440
    R1-CEP 2012-025 - Rev 02
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    SUCCINYLCHOLINE CHLORIDE USP
    Suxamethonium Chloride
    Succinylcholine Chloride (BP/USP)
    Issue/Submission Date
    2011-10-31
    2021-05-11
    2021-01-22
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    Anastrozole

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    26581
    Active
    ANASTROZOLE USP
    2012-10-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    anastrazole
    2021-01-22
    Application Number
    26581
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2023-08-01
    Filing Details
    ANASTROZOLE USP
    anastrazole
    Issue/Submission Date
    2012-10-26
    2021-01-22
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26580
    Active
    DOCETAXEL TRIHYDRATE USP
    2012-10-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Docetaxel
    2021-01-22
    Application Number
    26580
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2023-08-01
    Filing Details
    DOCETAXEL TRIHYDRATE USP
    Docetaxel
    Issue/Submission Date
    2012-10-26
    2021-01-22
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    • FDA
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    Oxaliplatin

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    27028
    Active
    OXALIPLATIN USP
    2013-04-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Oxaliplatin
    2021-01-22
    Application Number
    27028
    Indian CDSCO WC-0275
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2023-08-01
    Filing Details
    OXALIPLATIN USP
    Oxaliplatin
    Issue/Submission Date
    2013-04-02
    2021-01-22
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    • FDA
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    Gefitinib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2017-164 - Rev 00
    Withdrawn by Holder
    Gefitinib
    2019-03-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Gefitinib
    2021-01-22
    Application Number
    R0-CEP 2017-164 - Rev 00
    Indian CDSCO WC-0275
    Status
    Withdrawn by Holder
     
    Expired
    2023-08-01
    Filing Details
    Gefitinib
    Gefitinib
    Issue/Submission Date
    2019-03-27
    2021-01-22
    ASK
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    Neostigmine Methylsulfate

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2019-024 - Rev 00
    Suspended by EDQM GMP non-compliance
    Neostigmine metilsulfate
    2020-12-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Neostigmine monomethyl sulfate
    2021-01-22
    Application Number
    R0-CEP 2019-024 - Rev 00
    Indian CDSCO WC-0275
    Status
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    Neostigmine metilsulfate
    Neostigmine monomethyl sulfate
    Issue/Submission Date
    2020-12-18
    2021-01-22
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    • FDA
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    Paclitaxel

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    25843
    Inactive
    PACLITAXEL USP
    2012-03-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Paclitaxel (USP)
    2021-01-22
    Application Number
    25843
    Indian CDSCO WC-0275
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Expired
    2023-08-01
    Filing Details
    PACLITAXEL USP
    Paclitaxel (USP)
    Issue/Submission Date
    2012-03-06
    2021-01-22
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    Pemetrexed Disodium

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2015-141 - Rev 00
    Suspended by EDQM GMP non-compliance
    Pemetrexed disodium heptahydrate
    2022-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Pemetrexed Disodium Heptahydrate
    2021-01-22
    Application Number
    R1-CEP 2015-141 - Rev 00
    Indian CDSCO WC-0275
    Status
    Suspended by EDQM GMP non-compliance
     
    Expired
    2023-08-01
    Filing Details
    Pemetrexed disodium heptahydrate
    Pemetrexed Disodium Heptahydrate
    Issue/Submission Date
    2022-01-04
    2021-01-22
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    • FDA
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    Abiraterone Acetate

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Abiraterone Acetate USP
    2021-01-22
    Application Number
    Indian CDSCO WC-0275
    Status
     
    Expired
    2023-08-01
    Filing Details
    Abiraterone Acetate USP
    Issue/Submission Date
    2021-01-22
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    Aciclovir

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Acyclovir
    2021-01-22
    Application Number
    Indian CDSCO WC-0275
    Status
     
    Expired
    2023-08-01
    Filing Details
    Acyclovir
    Issue/Submission Date
    2021-01-22
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    Bendamustine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    Bendamustin hydrochloride IH
    2021-01-22
    Application Number
    Indian CDSCO WC-0275
    Status
     
    Expired
    2023-08-01
    Filing Details
    Bendamustin hydrochloride IH
    Issue/Submission Date
    2021-01-22
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    CHLORAMPHENICOL SODIUM SUCCINATE

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0275
    Expired
    CHLORAMPHENICOL SODIUM SUCCINATE
    2021-01-22
    Application Number
    Indian CDSCO WC-0275
    Status
     
    Expired
    2023-08-01
    Filing Details
    CHLORAMPHENICOL SODIUM SUCCINATE
    Issue/Submission Date
    2021-01-22
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    • FDA
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    Cisplatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2020-012 - Rev 00
    Withdrawn by Holder
    Cisplatin
    2021-06-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-012 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Cisplatin
    Issue/Submission Date
    2021-06-21
    ASK
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    • FDA
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    Colistimethate Sodium

    PDF Supplier PDF
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