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    Shandong Chenghui Shuangda Pharmaceutical-PSE
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    Shandong Chenghui Get Approval for Self-Developed Apalutamide API

    20 Mar 2026

    // PRESS RELEASE

    Global Recognition Prilocaine CEP Certified by EDQM

    19 Dec 2025

    // PRESS RELEASE

    Successful Approval of CEP Certificate for Lidocaine HCL

    19 Nov 2025

    // PRESS RELEASE

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    01 1Afoxolaner

    02 1Alectinib Hydrochloride

    03 1Apalutamide

    04 1Articaine Hydrochloride

    05 1Asundexian

    06 1Azetukalner

    07 1Baloxavir Marboxil

    08 1Bilastine

    09 1Brepocitinib

    10 1Bupivacaine

    11 1Bupivacaine Hydrochloride

    12 1Capivasertib

    13 1Celecoxib

    14 1Centanafadine

    15 1Cinchocaine Hydrochloride

    16 1Crisaborole

    17 1Dapagliflozin

    18 1Dapagliflozin Propanediol Monohydrate

    19 1Dienogest

    20 1Donepezil

    21 1Dyclonine

    22 1Elacestrant

    23 1Elinzanetant

    24 1Emoxypine Succinate

    25 1Fexuprazan

    26 1Fezolinetant

    27 1Finerenone

    28 1Fluralaner

    29 1Gamithromycin

    30 1Lacidipine

    31 1Letermovir

    32 1Levobupivacaine

    33 1Lidocaine

    34 1Lidocaine Hydrochloride

    35 1Lotilaner

    36 1Meldonium

    37 1Mepivacaine Hydrochloride

    38 1Metoclopramide

    39 1Molnupiravir

    40 1Nadifloxacin

    41 1Oclacitinib Maleate

    42 1Orforglipron Calcium Hydrate

    43 1Ozagrel Sodium

    44 1Ozenoxacin

    45 1Potassium Sulfate

    46 2Pramoxine Hydrochloride

    47 1Prilocaine

    48 1Prilocaine Hydrochloride

    49 1Remibrutinib

    50 1Resmetirom

    51 1Ropivacaine Hydrochloride

    52 1Ropivacaine Mesylate

    53 1Ruxolitinib Phosphate

    54 1Sarolaner

    55 1Sodium Sulfate

    56 2Sugammadex Sodium

    57 1Suzetrigine

    58 1Tadalafil

    59 1Terbinafine Hydrochloride

    60 1Tetracaine

    61 1Tetracaine Hydrochloride

    62 1Tolvaptan Sodium Phosphate

    63 1Upadacitinib

    64 1Urapidil Hydrochloride

    65 1Vonoprazan Fumarate

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    01

    Articaine Hydrochloride

    China

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

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    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-255 - Rev 01

    Issue Date : 2025-11-13

    Type : Chemical

    Substance Number : 1688

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-08-28

    Valid Till : 2027-08-27

    Written Confirmation Number : SD240047

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    02

    Meldonium

    China

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

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    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-113 - Rev 01

    Issue Date : 2024-09-17

    Type : Chemical

    Substance Number : 2624

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-07-10

    Valid Till : 2027-07-09

    Written Confirmation Number : SD240035

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    03

    Tetracaine Hydrochloride

    China

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

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    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    Certificate Number : CEP 2024-442 - Rev 00

    Issue Date : 2025-08-20

    Type : Chemical

    Substance Number : 57

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-06

    Valid Till : 2026-11-05

    Written Confirmation Number : SD230069

    Address of the Firm :

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    Shandong Chenghui Shuangda Pharmaceutical

    04

    Vonoprazan Fumarate

    China

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

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    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39107

    Submission : 2023-11-02

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-01-15

    Valid Till : 2027-01-14

    Written Confirmation Number : SD240003

    Address of the Firm :

    NDC KDMF arrow-down
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    Registrant Name : Pampia Co., Ltd.

    Registration Date : 2025-01-23

    Registration Number : Su719-2-ND

    Manufacturer Name : Shandong Chenghui Shuangda Pharmaceutical Co.,Ltd.

    Manufacturer Address : Economic Development Zone,Pingyuan County, DezhouCity, Shandong, PRChina

     VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    05

    Lidocaine

    China

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

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    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-285 - Rev 00

    Issue Date : 2025-10-09

    Type : Chemical

    Substance Number : 727

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-03-29

    Valid Till : 2026-03-28

    Written Confirmation Number : SD230027

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    06

    Lidocaine Hydrochloride

    China

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

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    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    ✖

    Certificate Number : CEP 2024-340 - Rev 00

    Issue Date : 2025-11-10

    Type : Chemical

    Substance Number : 227

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-02-07

    Valid Till : 2025-02-08

    Written Confirmation Number : SD220008

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    07

    Prilocaine

    China

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

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    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-300 - Rev 00

    Issue Date : 2025-12-19

    Type : Chemical

    Substance Number : 1362

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-11-15

    Valid Till : 2025-11-14

    Written Confirmation Number : SD220029

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    08

    Ropivacaine Hydrochloride

    China

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

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    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-148 - Rev 01

    Issue Date : 2025-01-20

    Type : Chemical

    Substance Number : 2335

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-05-30

    Valid Till : 2026-05-29

    Written Confirmation Number : SD230036

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    09

    Bupivacaine Hydrochloride

    China

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

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    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-08-02

    Valid Till : 2027-08-01

    Written Confirmation Number : SD240040

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical

    10

    Celecoxib

    China

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

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    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
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    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-06

    Valid Till : 2026-11-05

    Written Confirmation Number : SD230070

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    Shandong Chenghui Shuangda Pharmaceutical
    Contact Shandong Chenghui Shuangda Pharmaceutical and get a quotation

    Shandong Chenghui Shuangda Pharmaceutical is a supplier offers 66 products (APIs, Excipients or Intermediates).

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