Company profile for Zhuhai United Laboratories Co ., Ltd.

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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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Country
Country
China
Address
Address
Sanzao Science&Technology Park Natitional Hi-Tech Zone Zhuhai,Guangdong
Telephone
Telephone
+86-756-77876977787434
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Linkedin
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YouTube
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NEWS #PharmaBuzz

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

FDA
11 Jul 2018
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

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

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

EDQM
20 Jun 2015
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

01

Ampicillin Trihydrate

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Amoxicillin Trihydrate

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Amoxicillin Trihydrate

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Ampicillin Sodium

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Amoxicillin Trihydrate

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Clavulanic Acid

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Clavulanic Acid

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Clavulanic Acid

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Clavulanic Acid

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Sulbactam Sodium

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Sulbactam Sodium

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Amoxicillin Sodium

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Amoxicillin Sodium

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Amoxicillin Sodium

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Clavulanic Acid

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Clavulanic Acid

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USDMF

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JDMF

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Zhuhai United Laboratories Co ., Ltd.

Registration Number : 229MF10091

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

Initial Date of Registration : 2017-05-01

Latest Date of Registration : 2017-05-01

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Zhuhai United Laboratories Co ., Ltd.

Registration Number : 301MF10053

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

Initial Date of Registration : 2019-08-28

Latest Date of Registration : 2019-08-28

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03

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Zhuhai United Laboratories Co ., Ltd.

Registration Number : 230MF10038

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

Initial Date of Registration : 2018-02-28

Latest Date of Registration : 2018-06-20

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KDMF

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01

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Boryeong Co., Ltd.

Registration Date : 2012-12-21

Registration Number : 20101130-30-A-237-16(6)

Manufacturer Name : Zhuhai United Laboratories Co....

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

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Seongi Bio Co., Ltd.

Registration Date : 2012-06-08

Registration Number : 20101130-30-A-237-16(2)

Manufacturer Name : Zhuhai United Laboratories Co....

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

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03

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Penmix Co., Ltd.

Registration Date : 2010-11-30

Registration Number : 20101130-30-A-237-16

Manufacturer Name : Zhuhai United Laboratories Co....

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

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04

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Zhuhai United Laboratories Co ., Ltd.

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....

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

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05

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Zhuhai United Laboratories Co ., Ltd.

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....

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

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Chong Kun Dang Co., Ltd.

Registration Date : 2013-05-22

Registration Number : 20120608-30-A-260-18(3)

Manufacturer Name : Zhuhai United Laboratories Co....

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

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Samjin Pharmaceutical Co., Ltd.

Registration Date : 2013-01-17

Registration Number : 20120608-30-A-260-18(2)

Manufacturer Name : Zhuhai United Laboratories Co....

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

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08

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Seongi Bio Co., Ltd.

Registration Date : 2012-06-08

Registration Number : 20120608-30-A-260-18

Manufacturer Name : Zhuhai United Laboratories Co....

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

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09

DDL Conference
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Zhuhai United Laboratories Co ., Ltd.

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....

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

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Zhuhai United Laboratories Co ., Ltd.

Registrant Name : Penmix Co., Ltd.

Registration Date : 2013-06-04

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

Manufacturer Name : Zhuhai United Laboratories Co....

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

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LISTED APIs

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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 manufacture...
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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Zhuhai United Laboratories Co ., Ltd.

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.

About the Company : 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...

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REF. STANDARDS & IMPURITIES

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Inspections and registrations

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FDA

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01

FDA Audited

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Zhuhai United Laboratories Co ., Ltd.

City : Zhuhai

State :

Country/Area : China

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-10-23

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FDA Audited

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FDA Audited

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Zhuhai United Laboratories Co ., Ltd.

City : Zhuhai

State :

Country/Area : China

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-09-03

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GMP Certified

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Zhuhai United Laboratories Co ., Ltd.

Type : GMP Certificates

Number : 016/2015/RO

EudraGMDP Key : 11848

Country : China

Issue Date : 2015-06-15

Post Code : 519040

NCA Ref : 118481333433...

City : Zhuhai

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GMP Certified

EU
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GMP Certified

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Zhuhai United Laboratories Co ., Ltd.

Type : Non-Compliance Report

Number : NCF/011/RO

EudraGMDP Key : 11848

Country : China

Issue Date : 2015-06-15

Post Code : 519040

NCA Ref : 118481333433...

City : Zhuhai

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03

GMP Certified

EU
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GMP Certified

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Zhuhai United Laboratories Co ., Ltd.

Type : GMP Certificates

Number : 015/2015/RO

EudraGMDP Key : 11848

Country : China

Issue Date : 2015-06-15

Post Code : 519040

NCA Ref : 118481333433...

City : Zhuhai

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GMP Certified

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Zhuhai United Laboratories Co ., Ltd.

Type : GMP Certificates

Number : HMP/PT/43/2...

EudraGMDP Key : 11975

Country : China

Issue Date :

Post Code : CN 519040

NCA Ref : A065 1836 61...

City : ZHUHAI

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GDUFA

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GDUFA fees paid

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API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Zhuhai United Laboratories Co....

Business Address : No.2428 Anji Road Sanzao Tow...

FEI Number : 3006531950

Country : China

Paid in : 2019

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ABOUT THIS PAGE

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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.

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