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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Sharp is a leader in commercial packaging, clinical services, and sterile manufacturing.

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    As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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    01 1Amidopyrine

    02 1Aminophylline

    03 1Amlodipine Besylate

    04 1Amobarbital

    05 12Aspirin

    06 1Barbital Sodium

    07 1Bismuth Subsalicylate

    08 9Caffeine

    09 1Calcium Carbonate

    10 1Calcium Polycarbophil

    11 1Carbidopa

    12 1Enoxacin

    13 2Glimepiride

    14 3Hydrocortisone

    15 4Hydrocortisone Acetate

    16 6Ibuprofen

    17 1Ibuprofen Sodium

    18 2Icosapent Ethyl

    19 1Irisquinone

    20 2Levodopa

    21 5Meloxicam

    22 1Metamizole

    23 1Metamizole Magnesium

    24 1Metol

    25 1Nimodipine

    26 2Omega-3-Acid Ethyl Esters 90

    27 1Phenazon

    28 1Phenobarbital

    29 1Pipemidic Acid

    30 1Piperacillin Sodium

    31 2Prednisolone

    32 1Prednisone

    33 1Prednisone Acetate

    34 1Propyphenazone

    35 1Salicylic Acid

    36 1Sevelamer Carbonate

    37 1Sumatriptan

    38 2Theophylline

    39 1Tramadol Hydrochloride

    40 1Trimethoprim

    41 1Blank

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    01

    Caffeine

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

    PEGS Boston Summit
    Not Confirmed
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    Caffeine

    China

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
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    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-25

    Pay. Date : 2014-02-28

    DMF Number : 13092

    Submission : 1998-07-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-027 - Rev 03

    Issue Date : 2015-08-24

    Type : Chemical

    Substance Number : 267

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10007

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2019-05-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 58624-0302

    Start Marketing Date : 1987-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    02

    Glimepiride

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

    PEGS Boston Summit
    Not Confirmed
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    Glimepiride

    China

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

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    PEGS Boston Summit
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32319

    Submission : 2017-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-111 - Rev 00

    Issue Date : 2025-12-22

    Type : Chemical

    Substance Number : 2223

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10169

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2021-11-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0708

    Start Marketing Date : 2024-05-09

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Levodopa

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

    PEGS Boston Summit
    Not Confirmed
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    Levodopa

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-10-02

    Pay. Date : 2018-09-28

    DMF Number : 22598

    Submission : 2009-03-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-174 - Rev 02

    Issue Date : 2022-04-11

    Type : Chemical

    Substance Number : 38

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10029

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2009-02-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0234

    Start Marketing Date : 2000-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Roche Korea

    Registration Date : 2023-03-21

    Registration Number : 20210810-209-J-943(1)

    Manufacturer Name : Shandong Xinhua Pharmaceutical Co., Ltd

    Manufacturer Address : East Chemical Zone of Zibo High & New Technology Development Zone, Zibo, Shandong, PRChina 255075

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    04

    Theophylline

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

    PEGS Boston Summit
    Not Confirmed
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    Theophylline

    China

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

    arrow
    PEGS Boston Summit
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    • fda
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4633

    Submission : 1982-07-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-004 - Rev 08

    Issue Date : 2025-03-11

    Type : Chemical

    Substance Number : 299

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10482

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2005-09-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0713

    Start Marketing Date : 2026-01-19

    End Marketing Date : 2027-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Aspirin

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Aspirin

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-02-01

    Pay. Date : 2017-01-03

    DMF Number : 10730

    Submission : 1994-01-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-210 - Rev 05

    Issue Date : 2016-11-14

    Type : Chemical

    Substance Number : 309

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0452

    Start Marketing Date : 1985-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Carbidopa

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Carbidopa

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-04-20

    Pay. Date : 2017-12-04

    DMF Number : 27430

    Submission : 2013-07-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-052 - Rev 00

    Issue Date : 2022-04-20

    Type : Chemical

    Substance Number : 755

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0621

    Start Marketing Date : 1984-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2025-03-05

    Registration Number : 20250305-211-J-1798

    Manufacturer Name : Shandong Xinhua Pharmaceutical Co.,Ltd

    Manufacturer Address : Hutian Chemical Industrial Zone, Zibo, Shandong, PR 255075. China

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    07

    Icosapent Ethyl

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Icosapent Ethyl

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-12-10

    Pay. Date : 2021-05-21

    DMF Number : 34361

    Submission : 2020-03-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10044

    Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

    Initial Date of Registration : 2023-04-05

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Poonglim Pharmaceutical Co., Ltd.

    Registration Date : 2025-12-29

    Registration Number : 20250415-211-J-1850(1)

    Manufacturer Name : Shandong Xinhua Pharmaceutical Co.,Ltd

    Manufacturer Address : Hutian Chemical Industrial Zone, Zibo, Shandong, China

     VMF Others AUDIT arrow-down
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    08

    Metamizole

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Metamizole

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31035

    Submission : 2016-10-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2001-356 - Rev 05

    Issue Date : 2025-08-07

    Type : Chemical

    Substance Number : 1346

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0707

    Start Marketing Date : 2024-03-28

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Phenobarbital

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Phenobarbital

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27827

    Submission : 2013-12-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-269 - Rev 01

    Issue Date : 2023-11-03

    Type : Chemical

    Substance Number : 201

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 58624-0520

    Start Marketing Date : 1997-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Prednisolone

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Prednisolone

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40129

    Submission : 2024-07-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-204 - Rev 01

    Issue Date : 2024-10-23

    Type : Chemical

    Substance Number : 353

    Status : Valid

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    Contact Shandong Xinhua Pharmaceutical and get a quotation

    Shandong Xinhua Pharmaceutical is a supplier offers 56 products (APIs, Excipients or Intermediates).

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.