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    Company profile for Zhuhai United Laboratories Co ., Ltd.

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    REF. STANDARDS & IMPURITIES

    INSPECTIONS & REGISTRATIONS

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    About

    1. We are listed on Hong Kong Union Stock Exchange. Vertically integrated management for our six Production Bases: Finished Product Plant, HK; Bulk Medicine Plant, Zhuhai; Finished Product Plant, Zhongshan; Empty Capsule Plant, Kaiping; Intermediate Plant, Chengdu; and Intermediate Plant, Inner Mongolia 2. One of the largest antibiotic manufacturers in China. 3. One of the Top 20 enterprises in terms of sales among chemical ...
    1. We are listed on Hong Kong Union Stock Exchange. Vertically integrated management for our six Production Bases: Finished Product Plant, HK; Bulk Medicine Plant, Zhuhai; Finished Product Plant, Zhongshan; Empty Capsule Plant, Kaiping; Intermediate Plant, Chengdu; and Intermediate Plant, Inner Mongolia 2. One of the largest antibiotic manufacturers in China. 3. One of the Top 20 enterprises in terms of sales among chemical pharmaceutical enterprises of China. 4. The post-doctoral research station awarded by Ministry Of Personnel. 5. Domestic sales of three kinds of finished products rank first in China; Sales of Amoxicillin API rank first at home and abroad. 6. Our amoxicillin is the only API that has passed German GMP Certification, the EU's COS Certification and FDA DMF Application certification in China. Zhuhai United Laboratories Co., Ltd. (our API Plant) Located in Sanzao Technology Park in Zhuhai High-Tech Development Zone, Zhuhai United Laboratories Co., Ltd. occupies an area of 250,000 square meters with over 40% of greenery. During the initial construction phase, the design and construction of our factory and the introduction of equipment, production processes, organization structures and human resource management were completely conducted in accordance with the national GMP standards. All workshops passed national GMP certification in 1998. Subsequent to the GMP certification, our Zhuhai Bulk Medicine Factory has been advancing further and actively pursuing the registration and certification in a number of countries and regions, such as Germany, Europe and the United States. Among the successes with these efforts is that our Amoxicillin is the only pharmaceutical product that passed GMP certification in Germany and COS certification in the European Union in China, and has been accepted the registration by DMF of FDA in the United States, which lay the foundation for our enterprise to enter the international arena. We produce API. Main Products and our annual manufacturing capability: Semi-synthetic penicillin: 4000MT, Cephalosporin: 1000MT, Beta-lactamase inhibitors and blends: 100MT. Branch: United Laboratories (Inner Mongolia) Co., Ltd. Our company has already planned to be a high level company with the establishment of pharmaceutical production strictly in accordance with GMP standards in the initial construction. The most advanced technologies and equipment were introduced from all over the world for the production line, and substantial investment has been made in environmental protection. Our company has the state-of-the-art and environmentally-friendly facilities and the world's first class sewage water treatment technologies. Just the investment in environmental protection alone has already accounted for one fourth of our total investment. The sewage after treatment completely fulfills the emission standards as stipulated by the State. Main product and our annual manufacturing capability in the first stage project: 6APA: 5000MT Branch: United Laboratories (Chengdu) Co., Ltd. (Intermediate Plant) Located at Pengzhou Pharmaceutical Industrial Park in Chengdu, Sichuan, United Laboratories (Chengdu) Co., Ltd. was constructed in 2003 and substantially invested in by our company. Our factory occupies an area of 400,000 square meters approximately. Our company conforms to the current GMP standards. We have the most advanced technology and equipment in the world, and the level of wastewater discharge is lower than the latest standard in China. The main products and Manufacturing Capacity: Potassium Clavulanate: 60MT; 6-APA: 3000MT; 7-ACA: 800MT. Branch: TUL Hongkong was established in 1964 and has got British GMP approval. TUL Hongkong is our finished product plant with the largest scale and the most multi-dosage forms in Hong Kong. Branch: TUL Zhongshan was established in 1994 and is a Pioneer plant whose products have totally got GMP certificate.

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    CONTACT DETAILS

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    Zhuhai United Laboratories Co ., Ltd.China Flag
    Country
    Country
    China
    Address
    Address
    Sanzao Science&Technology Park Natitional Hi-Tech Zone Zhuhai,Guangdong
    Telephone
    Telephone
    +86-756-77876977787434
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://zhuhai-united.en.ywsp.com/
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    Linkedin
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    Twitter

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    NEWS #PharmaBuzz

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    Zhuhai United Laboratories Receives FDA Warning Letter
    Zhuhai United Laboratories Receives FDA Warning Letter

    11 Jul 2018

    // FDA

    https://www.pharmacompass.com/pdf/news/zhuhai-united-laboratories-receives-fda-warning-letter-1531282751.pdf

    FDA
    11 Jul 2018
    Share Share
    FDA Warns Chinese API Manufacturer
    FDA Warns Chinese API Manufacturer

    10 Jul 2018

    // Zachary Brennan RAPS

    https://www.raps.org/news-and-articles/news-articles/2018/7/fda-warns-chinese-api-manufacturer?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2010%20July%202018%20%281%29

    Zachary Brennan RAPS
    10 Jul 2018
    Share Share
    Eight Chinese pharma firms may be blacklisted over quality issues
    Eight Chinese pharma firms may be blacklisted over quality issues

    10 Jan 2018

    // ECONOMIC TIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/eight-chinese-pharma-firms-may-be-blacklisted-over-quality-issues/articleshow/62401572.cms

    ECONOMIC TIMES
    10 Jan 2018
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    China's Zhuhai United Laboratories fails EDQM Inspection
    China's Zhuhai United Laboratories fails EDQM Inspection

    20 Jun 2015

    // EDQM

    https://www.pharmacompass.com/pdf/news/chinas-zhuhai-united-laboratories.pdf

    EDQM
    20 Jun 2015
    Share Share
    Chinese drugmaker to build $60M API plant
    Chinese drugmaker to build $60M API plant

    08 Apr 2015

    // Eric Palmer FIERCE PHARMA MFG

    http://www.fiercepharmamanufacturing.com/story/chinese-drugmaker-build-60m-api-plant/2015-04-08

    Eric Palmer FIERCE PHARMA MFG
    08 Apr 2015
    Share Share

    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Ampicillin Trihydrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ampicillin Trihydrate

    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 Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-07-13

    Pay. Date : 2018-06-01

    DMF Number : 22857

    Submission : 2009-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-090 - Rev 04

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 168

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10038

    Registrant's Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong-519040, P. R. China

    Initial Date of Registration : 2018-02-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    Market
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    02

    Amoxicillin Trihydrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15377

    Submission : 2001-04-06

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-039 - Rev 03

    Issue Date : 2025-01-27

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10091

    Registrant's Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong-519040, P. R. China

    Initial Date of Registration : 2017-05-01

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Inist Pharm Co., Ltd.

    Registration Date : 2015-01-27

    Registration Number : 20101130-30-A-237-16(8)

    Manufacturer Name : Zhuhai United Laboratories Co.,Ltd.

    Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China

     VMF Others AUDIT arrow-down
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    03

    Ampicillin Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Ampicillin Sodium

    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-414 - Rev 00

    Issue Date : 2025-09-10

    Type : Chemical

    Substance Number : 578

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10053

    Registrant's Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong-519040, P. R. China

    Initial Date of Registration : 2019-08-28

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Seongyi Bio Co., Ltd.

    Registration Date : 2020-08-13

    Registration Number : 20200813-210-J-589

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd@The United Laboratories(Inner Mongolia) Co., Ltd.Co., Ltd.

    Manufacturer Address : No. 2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China@Bayannaoer Economy & Technology Park, Inner Mongolia-015000, PR China

     VMF Others AUDIT arrow-down
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    04

    Amoxicillin Trihydrate

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20517

    Submission : 2007-05-09

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-191 - Rev 04

    Issue Date : 2025-01-29

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Chong Kun Dang Co., Ltd.

    Registration Date : 2014-11-06

    Registration Number : 20101130-30-A-237-16(7)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China

     VMF Others AUDIT arrow-down
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    05

    Clavulanic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Clavulanic Acid

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26111

    Submission : 2012-05-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-163 - Rev 00

    Issue Date : 2019-11-12

    Type : Chemical

    Substance Number : 1653

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2017-06-28

    Registration Number : 20101130-113-F-56-15(7)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong 519040, PRChina

     VMF Others AUDIT arrow-down
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    06

    Clavulanic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Clavulanic Acid

    China

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28638

    Submission : 2014-09-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-187 - Rev 00

    Issue Date : 2019-11-13

    Type : Chemical

    Substance Number : 1653

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Penmix Co., Ltd.

    Registration Date : 2014-11-17

    Registration Number : 20121011-113-F-72-19(1)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PRChina

     VMF Others AUDIT arrow-down
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    07

    Sulbactam Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Sulbactam Sodium

    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 Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23769

    Submission : 2010-05-03

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-428 - Rev 00

    Issue Date : 2025-07-22

    Type : Chemical

    Substance Number : 2209

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Korea Chorus Co., Ltd.

    Registration Date : 2013-05-22

    Registration Number : 20130207-150-I-192-05(4)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : Sanzao Science & Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong. 519040, PR China

     VMF Others AUDIT arrow-down
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    08

    Amoxicillin Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amoxicillin Sodium

    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 CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-327 - Rev 00

    Issue Date : 2024-11-26

    Type : Chemical

    Substance Number : 577

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Penmix Co., Ltd.

    Registration Date : 2013-06-04

    Registration Number : 20120608-30-A-260-18(5)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China

     VMF Others AUDIT arrow-down
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    09

    Amoxicillin Sodium

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Amoxicillin Sodium

    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 CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-125 - Rev 03

    Issue Date : 2023-03-15

    Type : Chemical

    Substance Number : 577

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2017-06-28

    Registration Number : 20120608-30-A-260-18(6)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong 519040, PRChina

     VMF Others AUDIT arrow-down
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    10

    Clavulanic Acid

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Clavulanic Acid

    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 CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-083 - Rev 00

    Issue Date : 2021-11-26

    Type : Chemical

    Substance Number : 1140

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Penmix Co., Ltd.

    Registration Date : 2014-11-17

    Registration Number : 20121123-113-F-73-20(1)

    Manufacturer Name : Zhuhai United Laboratories Co., Ltd.

    Manufacturer Address : Sanzao Science & Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong, 519040, PR China

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    USDMF

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    01

    Amoxicillin (compacted)

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    02

    Amoxicillin Trihydrate Usp

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    03

    Amoxicillin Usp Bulk Substance

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    04

    Ampicillin Trihydrate

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    05

    Cefoperazone Sodium Usp

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    06

    Cefotaxime Sodium Usp

    China
    PEGS Boston Summit
    Not Confirmed
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    07

    Ceftriaxone Sodium Usp

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    08

    Cefuroxime Sodium Usp

    China
    PEGS Boston Summit
    Not Confirmed
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    09

    Meropenem Crude Non-sterile

    China
    PEGS Boston Summit
    Not Confirmed
    arrow

    10

    Meropenem For Injection Bulk Sterile

    China
    PEGS Boston Summit
    Not Confirmed
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    REF. STANDARDS & IMPURITIES

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    ABOUT THIS PAGE

    Contact Zhuhai United Laboratories Co ., Ltd and get a quotation

    Zhuhai United Laboratories Co ., Ltd is a supplier offers 19 products (APIs, Excipients or Intermediates).

    Find Ampicillin Trihydrate bulk with DMF, CEP, JDMF offered by Zhuhai United Laboratories Co ., Ltd

    Find Amoxicillin Trihydrate bulk with CEP, JDMF offered by Zhuhai United Laboratories Co ., Ltd

    Find Ampicillin Sodium bulk with CEP, JDMF offered by Zhuhai United Laboratories Co ., Ltd

    Find Amoxicillin Trihydrate bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd

    Find Clavulanic Acid bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd

    Find Sulbactam Sodium bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd

    Find Amoxicillin Sodium bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd

    Find Amoxicillin Trihydrate bulk offered by Zhuhai United Laboratories Co ., Ltd

    Find Cefoperazone Sodium bulk offered by Zhuhai United Laboratories Co ., Ltd

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