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    Company profile for Qilu Pharmaceutical

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    EVENTS

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    About

    Located in Jinan, Qilu Pharmaceutical is one of the leading pharmaceutical companies in China. It focuses on developing, manufacturing and marketing of generic drugs and active pharmaceutical ingredients in the therapeutic areas of Oncology, Cerebrovascular & Cardiovascular, Infections, Psychological and Neurological System, Respiratory System, Ophthalmological Diseases, etc. Always committing itself to meet the needs of the ...
    Located in Jinan, Qilu Pharmaceutical is one of the leading pharmaceutical companies in China. It focuses on developing, manufacturing and marketing of generic drugs and active pharmaceutical ingredients in the therapeutic areas of Oncology, Cerebrovascular & Cardiovascular, Infections, Psychological and Neurological System, Respiratory System, Ophthalmological Diseases, etc. Always committing itself to meet the needs of the patients and the society. Qilu pharmaceutical provides high-quality products by adopting advanced technology. Qilu has 8000 employees , 5,000 of them have junior college or above educational backgrounp.

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    CONTACT DETAILS

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    Qilu PharmaceuticalChina Flag
    Country
    Country
    China
    Address
    Address
    No.8888, Youyou Road, High-tech Zone, Jinan City, Shandong Province
    Telephone
    Telephone
    +86 0531-83126666
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.qilu-pharma.com/
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    Linkedin
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    Twitter

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    PEGS Boston Summit

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    NEWS #PharmaBuzz

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    Minghui And Qilu Pharma Update MHB088C Data In mCRPC At 2026
    Minghui And Qilu Pharma Update MHB088C Data In mCRPC At 2026

    01 Jun 2026

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/minghui-pharmaceutical-and-qilu-pharmaceutical-co-announces-updated-clinical-data-of-mhb088c-qlc5508-from-phase-iii-study-in-heavily-pretreated-mcrpc-patients-at-2026-asco-annual-meeting-302786692.html

    PR NEWSWIRE
    01 Jun 2026
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    Qilu’s Generics Sugammadex Receives Tentative Approval in US
    Qilu’s Generics Sugammadex Receives Tentative Approval in US

    15 Apr 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215575

    FDA
    15 Apr 2026
    Share Share
    Qilu’s Generics Revefenacin Receives Tentative Approval in US
    Qilu’s Generics Revefenacin Receives Tentative Approval in US

    23 Mar 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219523

    FDA
    23 Mar 2026
    Share Share
    Qilu’s Generics Nintedanib Receives Tentative Approval in US
    Qilu’s Generics Nintedanib Receives Tentative Approval in US

    17 Mar 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219708

    FDA
    17 Mar 2026
    Share Share
    Qilu Pharm’s Generics Doxorubicin HCl Receives Approval in US
    Qilu Pharm’s Generics Doxorubicin HCl Receives Approval in US

    03 Feb 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219881

    FDA
    03 Feb 2026
    Share Share
    Qilu Inks $120M, AI-Enabled Cardiometabolic Pact With Insilico
    Qilu Inks $120M, AI-Enabled Cardiometabolic Pact With Insilico

    27 Jan 2026

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/qilu-programs-path-cardiometabolic-disease-120m-ai-enabled-insilico-alliance

    FIERCE BIOTECH
    27 Jan 2026
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    ALL APIs

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    01

    Cefixime

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

    PEGS Boston Summit
    Not Confirmed
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    Cefixime

    China

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-11-28

    Pay. Date : 2022-08-19

    DMF Number : 36694

    Submission : 2022-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-361 - Rev 01

    Issue Date : 2025-06-19

    Type : Chemical

    Substance Number : 1188

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10199

    Registrant's Address : Ｎｏ．８４９　Ｄｏｎｇｊｉａ　Ｔｏｗｎ，　Ｌｉｃｈｅｎｇ　Ｄｉｓｔｒｉｃｔ，　Ｊｉｎａｎ，　Ｓｈａｎｄｏｎｇ，　Ｃｈｉｎａ

    Initial Date of Registration : 2014-10-27

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Seongyi Bio Co., Ltd.

    Registration Date : 2015-05-15

    Registration Number : 20150515-26-A-318-10

    Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd

    Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China_x000D_

     VMF Others AUDIT arrow-down
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    Product
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    Market
    Place

    02

    Cefoperazone Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefoperazone Sodium

    China

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20485

    Submission : 2006-12-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-202 - Rev 04

    Issue Date : 2024-04-24

    Type : Chemical

    Substance Number : 1404

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10174

    Registrant's Address : Ｎｏ．８４９　Ｄｏｎｇｊｉａ　Ｔｏｗｎ，　Ｌｉｃｈｅｎｇ　Ｄｉｓｔｒｉｃｔ，　Ｊｉｎａｎ，　Ｓｈａｎｄｏｎｇ，　Ｃｈｉｎａ

    Initial Date of Registration : 2024-12-25

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    03

    Cefpodoxime Proxetil

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cefpodoxime Proxetil

    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 : 2020-03-09

    Pay. Date : 2020-01-21

    DMF Number : 34502

    Submission : 2020-02-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-030 - Rev 01

    Issue Date : 2023-10-09

    Type : Chemical

    Substance Number : 2341

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10058

    Registrant's Address : Ｎｏ．８４９　Ｄｏｎｇｊｉａ　Ｔｏｗｎ，　Ｌｉｃｈｅｎｇ　Ｄｉｓｔｒｉｃｔ，　Ｊｉｎａｎ，　Ｓｈａｎｄｏｎｇ，　Ｃｈｉｎａ

    Initial Date of Registration : 2021-04-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51810-052

    Start Marketing Date : 2022-06-28

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongyi Bio Co., Ltd.

    Registration Date : 2022-07-01

    Registration Number : 20200618-25-A-359-12(1)

    Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.

    Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China

     VMF Others AUDIT arrow-down
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    Market
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    04

    Ceftazidime

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ceftazidime

    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 : 2018-12-10

    Pay. Date : 2013-09-06

    DMF Number : 20481

    Submission : 2006-12-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-195 - Rev 00

    Issue Date : 2022-11-10

    Type : Chemical

    Substance Number : 1405

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10077

    Registrant's Address : Ｎｏ．８４９　Ｄｏｎｇｊｉａ　Ｔｏｗｎ，　Ｌｉｃｈｅｎｇ　Ｄｉｓｔｒｉｃｔ，　Ｊｉｎａｎ，　Ｓｈａｎｄｏｎｇ，　Ｃｈｉｎａ

    Initial Date of Registration : 2020-07-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51810-006

    Start Marketing Date : 2020-04-04

    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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    Market
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    05

    Ceftriaxone

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ceftriaxone

    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 : 2013-08-29

    Pay. Date : 2012-12-19

    DMF Number : 20482

    Submission : 2006-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-017 - Rev 04

    Issue Date : 2025-08-18

    Type : Chemical

    Substance Number : 991

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10095

    Registrant's Address : Ｎｏ．８４９　Ｄｏｎｇｊｉａ　Ｔｏｗｎ，　Ｌｉｃｈｅｎｇ　Ｄｉｓｔｒｉｃｔ，　Ｊｉｎａｎ，　Ｓｈａｎｄｏｎｇ，　Ｃｈｉｎａ

    Initial Date of Registration : 2020-08-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51810-002

    Start Marketing Date : 1998-10-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Union Pharmaceutical Co., Ltd.

    Registration Date : 2023-05-15

    Registration Number : 20130905-116-G-110-10(3)

    Manufacturer Name : Quilu Antibiotics Pharmaceutical Co., Ltd.

    Manufacturer Address : No.849 DongJia Town, Licheng District, Jinan, Shandong, China.

     VMF Others AUDIT arrow-down
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    Market
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    06

    Amikacin Sulfate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amikacin Sulfate

    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 : 2013-11-25

    Pay. Date : 2013-11-18

    DMF Number : 20874

    Submission : 2007-09-18

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 307MF10133

    Registrant's Address : No. 10678 Wenliang Road, Dongjia Town, Licheng District, Jinan, Shandong Province, P. R. CHINA

    Initial Date of Registration : 2025-10-29

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    07

    Cisplatin

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Cisplatin

    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 : 23985

    Submission : 2010-05-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-122 - Rev 03

    Issue Date : 2025-09-24

    Type : Chemical

    Substance Number : 599

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    08

    Irinotecan Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Irinotecan Hydrochloride

    China

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-01

    Pay. Date : 2015-05-22

    DMF Number : 24133

    Submission : 2010-08-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-276 - Rev 02

    Issue Date : 2025-09-22

    Type : Chemical

    Substance Number : 2675

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    09

    Ondansetron Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ondansetron Hydrochloride

    China

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17034

    Submission : 2003-12-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-174 - Rev 04

    Issue Date : 2023-02-01

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    10

    Oxaliplatin

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Oxaliplatin

    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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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-15

    Pay. Date : 2013-09-06

    DMF Number : 23530

    Submission : 2010-02-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-071 - Rev 03

    Issue Date : 2021-09-16

    Type : Chemical

    Substance Number : 2017

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 67184-0007

    Start Marketing Date : 2019-11-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Inspections and registrations

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    THIRD-PARTY AUDIT

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    01

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Qilu Antibiotics

    Country : China

    City/Region : Dongja Town

    Audit Date : 2026-08-12

    Audit Type : On-Site

    Eurofins Assurance

    02

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Qilu Pharmaceutical

    Country : China

    City/Region : Gong Ye Bei Road

    Audit Date : 2026-07-10

    Audit Type : On-Site

    Eurofins Assurance

    03

    Eurofins Assurance

    Belgium
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    CPhI Milan
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Shandong Anxin Pharmaceutical

    Country : China

    City/Region : Dezhou City, Shandong

    Audit Date : 2026-05-28

    Audit Type : On-Site

    Eurofins Assurance

    04

    Eurofins Assurance

    Belgium
    arrow
    Get Site Audit
    CPhI Milan
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Qilu Antibiotics

    Country : China

    City/Region : Dongja Town

    Audit Date : 2025-04-22

    Audit Type : On-Site

    Eurofins Assurance

    05

    Eurofins Assurance

    Belgium
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    Get Site Audit
    CPhI Milan
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothEurofins Assurance: Ensuring compliance, quality, and safety with expert inspection and certification.

    Shandong Anxin (Ex Qilu)

    Country : China

    City/Region : Dongjia Town

    Audit Date : 2024-02-26

    Audit Type : On-Site

    Eurofins Assurance

    06

    AuditGMP Pharma

    Spain
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    CPhI Milan
    Attending
    • fda
    • EDQM
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    Qilu Antibiotics Pharmaceutical Co., Ltd.

    Country : China

    City/Region : Jinan

    Audit Date : Nov-26

    Audit Type : On-Site

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    Qilu Antibiotics Pharmaceutical Co., Ltd.

    Country : China

    City/Region : Jinan

    Audit Date : Nov-23

    Audit Type : On-Site

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    Qilu Pharmaceuticals Co. Ltd. (Laoling Site)

    Country : China

    City/Region : Laoling County, Dezhou

    Audit Date : May-25

    Audit Type : On-Site

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    Qilu Pharmaceutical Co., Ltd. - Gongbei Site

    Country : China

    City/Region : Jinan

    Audit Date : Mar-25

    Audit Type : On-Site

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    Shandong Anxin Pharmaceutical Co., Ltd. - Laoling Site

    Country : China

    City/Region : Dezhou City

    Audit Date : Jul-25

    Audit Type : On-Site

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    Contact Qilu Pharmaceutical and get a quotation

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