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    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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    Zhuhai United Laboratories Co ., Ltd.China Flag
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    China
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    Sanzao Science&Technology Park Natitional Hi-Tech Zone Zhuhai,Guangdong
    Telephone
    Telephone
    +86-756-77876977787434
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    enquiries@pharmacompass.com
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    http://zhuhai-united.en.ywsp.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    16 Dec 2024
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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval

    Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval

    First‑in‑class drugs are therapies with entirely new approaches that improve patient outcomes and fundamentally change treatment paradigms.This week, PharmaCompass brings a compilation of 2025’s most promising first-in-class drug candidates. With their US Food and Drug Administration (FDA) action dates in 2025, many of these drugs, once approved, hold the potential of becoming blockbusters.Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten poised to transform patient careIonis’ donidalorsen is an exciting candidate designed to tackle hereditary angioedema (HAE), a rare condition marked by unpredictable and potentially life‑threatening swelling episodes.This novel antisense oligonucleotide works by “silencing” the messenger RNA that codes for prekallikrein — a protein that triggers inflammation leading to swelling. Instead of blocking a protein once it’s made, donidalorsen stops the cell from producing it in the first place. This precision approach could mean fewer infusions and reduced side effects compared to traditional treatments.Another promising candidate is Sanofi and Alnylam Pharmaceuticals’ fitusiran. It employs the technology of small interfering RNA (siRNA) to lower levels of antithrombin — a natural protein that, when in excess, can impair the blood’s ability to clot. By reducing antithrombin, fitusiran rebalances the blood’s clotting process in patients with hemophilia A and B.Similarly, Cytokinetics’ aficamten is designed to treat obstructive hypertrophic cardiomyopathy (oHCM), a condition in which the heart muscle becomes abnormally thick, obstructing blood flow. Aficamten works by inhibiting cardiac myosin, a protein that drives heart muscle contraction. This helps relieve symptoms like shortness of breath and chest pain. If approved, aficamten is expected to rake in annual sales of US$ 2.8 billion by 2030.UroGen, J&J’s candidates eye US$ 5 bn markets; AbbVie, Summit’s meds target lung cancerUroGen Pharma’s UGN‑102 is poised to redefine the treatment of non‑muscle‑invasive bladder cancer. This innovative formulation uses a reverse thermal gel technology that transforms from a liquid into a gel once inside the bladder. This change ensures that the chemotherapeutic agent, mitomycin, remains in contact with the bladder lining for a longer period, increasing its effectiveness at eradicating cancer cells and reducing the risk of recurrence.For patients, UGN‑102 could mean a non‑surgical, outpatient treatment option that is less invasive than traditional surgical methods. If approved, UGN-102 could address a US market of approximately 82,000 patients annually, translating into a market opportunity exceeding US$ 5 billion, according to company estimates.Johnson & Johnson’s nipocalimab is a new treatment aimed at helping people with autoimmune diseases — a group of conditions where the body’s defense system mistakenly attacks its own healthy cells. Nipocalimab works by blocking the neonatal Fc receptor (FcRn), thereby lowering the levels of pathogenic antibodies that drive many autoimmune disorders. J&J had acquired this FcRn blocker in 2020 as part of its US$ 6.5 billion takeover of Momenta Pharmaceuticals. J&J is trialing the drug in as many as 10 indications and expects peak annual sales in excess of US$ 5 billion.AbbVie’s antibody-drug conjugate (ADC), telisotuzumab vedotin, is designed as a “guided-missile” to deliver toxic drugs directly to cancer cells while sparing healthy tissues. Telisotuzumab vedotin targets c‑Met, a receptor that is over-expressed in certain cancers such as non‑small cell lung cancer (NSCLC). There are currently no approved anti-cancer therapies specifically for c-Met over-expressing NSCLC.Summit Therapeutics’ ivonescimab is a cutting‑edge bispecific antibody designed specifically for NSCLC. Unlike traditional therapies that target a single molecule, ivonescimab binds simultaneously to a tumor-specific antigen on cancer cells and to a receptor on T cells, effectively bringing these two together so the body’s own immune system can recognize and attack the tumor. This dual engagement strategy helps overcome common mechanism tumors.Insmed’s Brensocatib is an innovative, first‐in‐class oral inhibitor of dipeptidyl peptidase‑1 (DPP‑1) that targets a key step in the inflammatory cascade. DPP‑1 is responsible for activating neutrophil serine proteases — enzymes that, when overactive, can cause significant lung tissue damage in conditions such as non‑cystic fibrosis bronchiectasis. Brensocatib is expected to clock annual sales of US$ 2.8 billion by 2030.Gepotidacin, an investigational antibiotic developed by GSK, is poised to make a significant impact in the treatment of uncomplicated urinary tract infections (uUTIs) and urogenital gonorrhea. If approved, it would be the first oral antibiotic in a new class for uUTIs in over two decades.Arrowhead, Regenxbio, Ultragenyx address rare, genetic diseasesArrowhead Pharmaceuticals is developing an innovative gene-targeting therapy — plozasiran. This drug uses RNA interference (RNAi) to interrupt the gene responsible for producing apolipoprotein C‑III (APOC3), a protein that regulates blood triglyceride levels. For people with severe hypertriglyceridemia or familial chylomicronemia syndrome (FCS) — a severe and rare genetic disease for which there are currently no FDA‑approved treatments — high triglyceride levels can lead to pancreatitis and other serious cardiovascular issues. Regenxbio’s RGX‑121 is a one‑time gene therapy candidate for Hunter syndrome (MPS 2), a rare, inherited disorder that causes progressive neurological decline. The therapy uses a harmless virus to deliver a functional copy of the gene encoding iduronate‑2‑sulfatase (I2S) directly into the central nervous system. By restoring the missing enzyme, RGX‑121 aims to slow or even reverse the harmful buildup of substances in the brain that drive the disease’s progression.Another promising candidate is Ultragenyx Pharmaceuticals’ one-time intravenous gene therapy UX111 for Sanfilippo syndrome type A (MPS 3A). This devastating disorder, which leads to severe neurodegeneration in children, currently has no effective treatment. UX111 uses an adeno‑associated virus (AAV) to deliver a working copy of the SGSH gene, the deficiency of which is responsible for the disease. By enabling the body to produce the missing enzyme, UX111 holds the promise of slowing or even halting the progression of neurodegeneration.Our viewThis year has already seen several first-in-class approvals, such as Vertex’s suzetrigine (Journavx), a pioneering non‐opioid analgesic redefining pain management; SpringWorks’ mirdametinib (Gomekli), a breakthrough MEK inhibitor for a genetic disorder that often leads to the growth of benign tumors along nerves and; AstraZeneca and Daiichi’s ADC datopotamab deruxtecan (Datroway).Despite the volatile political environment in the US and its impact on federal agencies like the FDA, we are hopeful that many of the first-in-class drugs mentioned in this article will make a debut in 2025. 
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    https://www.pharmacompass.com/radio-compass-blog/top-first-in-class-drug-candidates-of-2025-ionis-donidalorsen-sanofi-s-fitusiran-cytokinetics-aficamten-await-fda-approval

    #Phispers by PHARMACOMPASS
    27 Feb 2025
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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
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    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
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    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
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    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
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    ALL APIs

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    01

    Ampicillin Trihydrate

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

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    Ampicillin Trihydrate

    China

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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
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    Certificate Number : CEP 2010-090 - Rev 04

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 168

    Status : Valid

     JDMF arrow-down
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    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 :

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    02

    Amoxicillin Trihydrate

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    Amoxicillin Trihydrate

    China

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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
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    Certificate Number : CEP 2006-039 - Rev 03

    Issue Date : 2025-01-27

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF arrow-down
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    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
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    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

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    03

    Amoxicillin Trihydrate

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

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    Amoxicillin Trihydrate

    China

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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
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    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 : 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

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    04

    Clavulanic Acid

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

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    Clavulanic Acid

    China

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26111

    Submission : 2012-05-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    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
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    Registrant Name : Sungwoo 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

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    05

    Clavulanic Acid

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

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    Clavulanic Acid

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28638

    Submission : 2014-09-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2013-133 - Rev 02

    Issue Date : 2024-03-04

    Type : Chemical

    Substance Number : 1140

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
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    Registrant Name : Sungwoo 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

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    06

    Amoxicillin Sodium

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    Amoxicillin Sodium

    China

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    USDMF CEP/COS arrow-down
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    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 : Sungwoo 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
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    Market
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    07

    Amoxicillin Sodium

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

    Natural Products Expo
    Not Confirmed
    arrow

    Amoxicillin Sodium

    China

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

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    Natural Products Expo
    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 : Sungwoo 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
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    Market
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    08

    Ampicillin Sodium

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

    Natural Products Expo
    Not Confirmed
    arrow

    Ampicillin Sodium

    China

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

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    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS 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 : Seongi Bio Co., Ltd.

    Registration Date : 2020-08-13

    Registration Number : 20200813-210-J-589

    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
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    Market
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    09

    Clavulanic Acid

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

    Natural Products Expo
    Not Confirmed
    arrow

    Clavulanic Acid

    China

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

    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF 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 : Sungwoo 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
    blank

    Product
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    Market
    Place

    10

    Clavulanic Acid

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

    Natural Products Expo
    Not Confirmed
    arrow

    Clavulanic Acid

    China

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

    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF 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 : Sungwoo 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
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    CEP/COS

    read-more
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    01

    Amoxicillin sodium, Sterile

    CEP/COS

    Natural Products Expo
    Not Confirmed
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    02

    Amoxicillin sodium, Sterile (Process B)

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow

    03

    Amoxicillin trihydrate, Compacted

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow

    04

    Amoxicillin trihydrate, Micronised, norm...

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow

    05

    Ampicillin trihydrate, Compacted, powder

    CEP/COS

    Natural Products Expo
    Not Confirmed
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    06

    Cilastatin sodium, Sterile

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow

    07

    Imipenem monohydrate, Sterile

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow

    08

    Potassium clavulanate

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow

    09

    Potassium clavulanate, diluted, With mic...

    CEP/COS

    Natural Products Expo
    Not Confirmed
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    10

    Potassium clavulanate, diluted, With sil...

    CEP/COS

    Natural Products Expo
    Not Confirmed
    arrow
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    LISTED APIs

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    CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL

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    Market
    Place

    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.
    blank

    01

    CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL

    China
    Natural Products Expo
    Not Confirmed
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    CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL

    China
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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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    ABOUT THIS PAGE

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

    Zhuhai United Laboratories Co ., Ltd. is a supplier offers 15 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 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 Amoxicillin Sodium bulk with CEP offered by Zhuhai United Laboratories Co ., Ltd.

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

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    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.

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