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    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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    PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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    Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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    BrightGene Bio-Medical Technology Co.,Ltd

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    01 1Amphotericin B

    02 1Anidulafungin

    03 1Ansamitocin P3

    04 1Apalutamide

    05 4Argatroban

    06 1CAS 184177-83-1

    07 1CAS 361440-67-7

    08 1CAS-149809-43-8

    09 1Cabergoline

    10 1Carboprost Tromethamine

    11 4Caspofungin

    12 4Dalbavancin

    13 1Dienogest

    14 1Doramectin

    15 1Dydrogesterone

    16 1Eldecalcitol

    17 1Emodepside

    18 1Entecavir

    19 1Entecavir Intermediate VIII Isomer

    20 1Entecavir Monohydrate

    21 1Eribulin

    22 2Everolimus

    23 1Exatecan

    24 1Ferric Carboxymaltose

    25 1Ferric Pyrophosphate Citrate

    26 2Fidaxomicin

    27 1Fluralaner

    28 2Fondaparinux Sodium

    29 1Gadobutrol

    30 1Hydroxy Echinocandin

    31 1Ibrexafungerp Citrate

    32 1Iodixanol

    33 1Iomeprol

    34 1Iopromide

    35 1Iron Sucrose

    36 1Isavuconazonium Sulfate

    37 1Josamycin

    38 1Laninamivir Octanoate

    39 1Lurbinectedin

    40 2Maytansinoid DM1

    41 2Micafungin

    42 1Midostaurin

    43 1Molnupiravir

    44 1Mycophenolate Sodium

    45 1Nicergoline

    46 1Nystatin

    47 1Obeticholic Acid

    48 1Omadacycline

    49 1Oritavancin

    50 1Oseltamivir Phosphate

    51 1Pemetrexed

    52 1Pimecrolimus

    53 4Posaconazole

    54 1Regadenoson Monohydrate

    55 1Relugolix

    56 1Saxagliptin

    57 2Selamectin

    58 1Sirolimus

    59 1Spinosyn D

    60 1Staurosporine

    61 4Sugammadex Sodium

    62 1Tacrolimus

    63 1Trabectedin

    64 1Trientine Hydrochloride

    65 1Voclosporin

    66 1Blank

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    01

    Entecavir

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Entecavir

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-12-15

    Pay. Date : 2017-09-29

    DMF Number : 31949

    Submission : 2017-08-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-283 - Rev 01

    Issue Date : 2024-12-19

    Type : Chemical

    Substance Number : 2815

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10118

    Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123

    Initial Date of Registration : 2016-06-24

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Place

    02

    Argatroban

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Argatroban

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-10-01

    Pay. Date : 2021-04-14

    DMF Number : 35491

    Submission : 2020-12-26

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10140

    Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123

    Initial Date of Registration : 2023-12-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62227-015

    Start Marketing Date : 2018-01-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (2kg/2kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Otran Korea Co., Ltd.

    Registration Date : 2025-04-30

    Registration Number : 20250430-210-J-1853

    Manufacturer Name : BrightGene Pharmaceutical Co.,Ltd.

    Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu 215123, China

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    03

    Eribulin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Eribulin

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-02-08

    Pay. Date : 2020-11-06

    DMF Number : 35118

    Submission : 2020-10-28

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 304MF10030

    Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123

    Initial Date of Registration : 2022-02-10

    Latest Date of Registration :

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    04

    Everolimus

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Everolimus

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-11-01

    Pay. Date : 2020-09-21

    DMF Number : 32020

    Submission : 2017-09-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-367 - Rev 00

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 2918

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62227-019

    Start Marketing Date : 2020-12-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Otran Pharm Korea Co., Ltd.

    Registration Date : 2020-08-06

    Registration Number : Su695-3-ND

    Manufacturer Name : BrightGene Pharmaceutical Co. Ltd@[Sirolimus Manufacturer]BrightGene Fine Chemical Co., Ltd

    Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China@[Sirolimus Manufacturing Plant]No. 22 Binjiang South Road, Taixing Economic Development Zone, Taizhou Jiangsu, China

     VMF Others AUDIT arrow-down
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    05

    Micafungin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Micafungin

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-05-03

    Pay. Date : 2017-04-06

    DMF Number : 31449

    Submission : 2017-03-03

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 230MF10169

    Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123

    Initial Date of Registration : 2018-12-19

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62227-005

    Start Marketing Date : 2014-07-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Otran Pharm Korea Co., Ltd.

    Registration Date : 2019-06-25

    Registration Number : Su695-1-ND

    Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.

    Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China

     VMF Others AUDIT arrow-down
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    Market
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    06

    Oseltamivir Phosphate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Oseltamivir Phosphate

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-10-07

    Pay. Date : 2021-08-27

    DMF Number : 35876

    Submission : 2021-04-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-488 - Rev 01

    Issue Date : 2025-11-05

    Type : Chemical

    Substance Number : 2422

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62227-026

    Start Marketing Date : 2024-04-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Otran Korea Co., Ltd.

    Registration Date : 2021-05-18

    Registration Number : 20210518-209-J-995

    Manufacturer Name : BrightGene Fine Chemical Co., Ltd.

    Manufacturer Address : No.22 Binjiang South Road, Taixing Economic Development Zone, Taizhou City, Jiangsu, 225400, China

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    07

    Sugammadex Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Sugammadex Sodium

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-10-28

    Pay. Date : 2019-07-01

    DMF Number : 33904

    Submission : 2019-06-06

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10018

    Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123

    Initial Date of Registration : 2023-02-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62227-016

    Start Marketing Date : 2020-02-25

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2022-12-22

    Registration Number : Number 695-5-ND(3)

    Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.@BrightGene Fine Chemical Co., Ltd.

    Manufacturer Address : No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu 215123, China@No.22 Binjiang South Road, Taixing Economic Development Zone, Taizhou City, Jiangsu, 225400, China

     VMF Others AUDIT arrow-down
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    08

    Anidulafungin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Anidulafungin

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32010

    Submission : 2017-08-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62227-007

    Start Marketing Date : 2015-07-27

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Otran Pharm Korea Co., Ltd.

    Registration Date : 2019-11-11

    Registration Number : Su695-2-ND

    Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.

    Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China

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    09

    Ansamitocin P3

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Ansamitocin P3

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34434

    Submission : 2019-12-23

    Status : Active

    Type : II

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    10

    Argatroban

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Argatroban

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Registration Number : 304MF10018

    Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China 215123

    Initial Date of Registration : 2022-01-26

    Latest Date of Registration :

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    Contact Brightgene Bio-medical Technology Co.,ltd and get a quotation

    Brightgene Bio-medical Technology Co.,ltd is a supplier offers 73 products (APIs, Excipients or Intermediates).

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