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Digital content

11 Jul 2018
// FDA
https://www.pharmacompass.com/pdf/news/zhuhai-united-laboratories-receives-fda-warning-letter-1531282751.pdf

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

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

20 Jun 2015
// EDQM

08 Apr 2015
// Eric Palmer FIERCE PHARMA MFG
http://www.fiercepharmamanufacturing.com/story/chinese-drugmaker-build-60m-api-plant/2015-04-08
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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
Certificate Number : CEP 2010-090 - Rev 04
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 168
Status : Valid
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 :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15377
Submission : 2001-04-06
Status : Inactive
Type : II
Certificate Number : CEP 2006-039 - Rev 03
Issue Date : 2025-01-27
Type : Chemical
Substance Number : 260
Status : Valid
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 :
Registrant Name : Inist Farm 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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-414 - Rev 00
Issue Date : 2025-09-10
Type : Chemical
Substance Number : 578
Status : Valid
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 :
Registrant Name : Seongi 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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20517
Submission : 2007-05-09
Status : Inactive
Type : II
Certificate Number : CEP 2007-191 - Rev 04
Issue Date : 2025-01-29
Type : Chemical
Substance Number : 260
Status : Valid
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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26111
Submission : 2012-05-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2013-163 - Rev 00
Issue Date : 2019-11-12
Type : Chemical
Substance Number : 1653
Status : Valid
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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28638
Submission : 2014-09-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2013-187 - Rev 00
Issue Date : 2019-11-13
Type : Chemical
Substance Number : 1653
Status : Valid
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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23769
Submission : 2010-05-03
Status : Inactive
Type : II
Certificate Number : CEP 2024-428 - Rev 00
Issue Date : 2025-07-22
Type : Chemical
Substance Number : 2209
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2013-125 - Rev 03
Issue Date : 2023-03-15
Type : Chemical
Substance Number : 577
Status : Valid
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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-327 - Rev 00
Issue Date : 2024-11-26
Type : Chemical
Substance Number : 577
Status : Valid
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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2015-083 - Rev 00
Issue Date : 2021-11-26
Type : Chemical
Substance Number : 1140
Status : Valid
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2013-05-22
Registration Number : 20101130-113-F-56-15(5)
Manufacturer Name : Zhuhai United Laboratories Co., Ltd.
Manufacturer Address : No.2428, Anji Road, Sanzao Town, Jinwan District, Zhuhai, Guangdong, 519040, PR China

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21197
Submission : 2008-01-04
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20517
Submission : 2007-05-09
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15377
Submission : 2001-04-06
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2018-07-13
Pay. Date : 2018-06-01
DMF Number : 22857
Submission : 2009-06-10
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26115
Submission : 2012-05-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25844
Submission : 2012-02-29
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25946
Submission : 2012-02-29
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26114
Submission : 2012-05-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23858
Submission : 2010-05-28
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25891
Submission : 2012-04-16
Status : Inactive
Type : II

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CEP/COS
Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : R1-CEP 2013-125 - Rev 03
Status : Valid
Issue Date : 2023-03-15
Type : Chemical
Substance Number : 577

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Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : CEP 2024-327 - Rev 00
Status : Valid
Issue Date : 2024-11-26
Type : Chemical
Substance Number : 577

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Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : CEP 2007-191 - Rev 04
Status : Valid
Issue Date : 2025-01-29
Type : Chemical
Substance Number : 260

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Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : CEP 2006-039 - Rev 03
Status : Valid
Issue Date : 2025-01-27
Type : Chemical
Substance Number : 260

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Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : CEP 2024-414 - Rev 00
Status : Valid
Issue Date : 2025-09-10
Type : Chemical
Substance Number : 578

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Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : CEP 2010-090 - Rev 04
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 168

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CEP/COS
Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : R1-CEP 2010-184 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-10-26
Type : Chemical
Substance Number : 1408

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CEP/COS
Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : R1-CEP 2010-163 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-10-26
Type : Chemical
Substance Number : 1226

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CEP/COS
Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : R1-CEP 2015-083 - Rev 00
Status : Valid
Issue Date : 2021-11-26
Type : Chemical
Substance Number : 1140

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Zhuhai United Laboratories Co ., Ltd.
Certificate Numbers : R1-CEP 2013-163 - Rev 00
Status : Valid
Issue Date : 2019-11-12
Type : Chemical
Substance Number : 1653

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 500mg
Packaging :
Brand Name : Amoxicillin
Approval Date : 30-07-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1g
Packaging :
Brand Name : Amoxicillin
Approval Date : 30-07-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1000mg; 200mg
Packaging :
Brand Name : Amoxicilin? cu acid clavulani...
Approval Date : 26-08-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 500mg; 100mg
Packaging :
Brand Name : Amoxicilin? cu acid clavulani...
Approval Date : 26-08-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1g
Packaging :
Brand Name : Cefazolin
Approval Date : 26-08-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 2g
Packaging :
Brand Name : cefoperazone
Approval Date : 07-10-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1g; 1g
Packaging :
Brand Name : Cefoperazone with Sulbactam
Approval Date : 26-08-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1g
Packaging :
Brand Name : Cefotaxime
Approval Date : 26-08-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 1g
Packaging :
Brand Name : Ceftriaxon
Approval Date : 30-07-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Zhuhai United Laboratories Co ., Ltd.
Dosage Form : Injection/Infusion Solution
Dosage Strength : 2g
Packaging :
Brand Name : Ceftriaxon
Approval Date : 30-07-2021
Application Number :
Regulatory Info :
Registration Country : Moldova

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
Zhuhai United Laboratories Co ., Ltd. is a supplier offers 19 products (APIs, Excipients or Intermediates).
Find a price of Ampicillin Trihydrate bulk with DMF, CEP, JDMF offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Amoxicillin Trihydrate bulk with CEP, JDMF offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Ampicillin Sodium bulk with CEP, JDMF offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Amoxicillin Trihydrate bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Clavulanic Acid bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Sulbactam Sodium bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Amoxicillin Sodium bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Amoxicillin Trihydrate bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Cefoperazone Sodium bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Cefotaxime bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Ceftriaxone bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Cefuroxime Sodium bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Cilastatin Sodium bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Imipenem bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Meropenem bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Amoxicillin Sodium bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Clavulanic Acid bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Sodium Sulfate bulk offered by Zhuhai United Laboratories Co ., Ltd.
Find a price of Sulbactam bulk offered by Zhuhai United Laboratories Co ., Ltd.