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20 All APIs, 13 USDMF, 11 CEP/COS, 3 JDMF, 28 KDMF, 1 Listed APIs

20 All APIs
13 USDMF
11 CEP/COS
3 JDMF
28 KDMF
1 Listed APIs

INSPECTIONS & REGISTRATIONS

2 FDA, 4 EDQM, 1 GDUFA

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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 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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Sanzao Science&Technology Park Natitional Hi-Tech Zone Zhuhai,Guangdong

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets

Impressions: 95

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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.

Impressions: 3550

NEWS #PharmaBuzz

Zhuhai United Laboratories Receives FDA Warning Letter

11 Jul 2018

// FDA

FDA Warns Chinese API Manufacturer

10 Jul 2018

// Zachary Brennan RAPS

Eight Chinese pharma firms may be blacklisted over quality issues

10 Jan 2018

// ECONOMIC TIMES

China's Zhuhai United Laboratories fails EDQM Inspection

20 Jun 2015

// EDQM

Chinese drugmaker to build $60M API plant

08 Apr 2015

// Eric Palmer FIERCE PHARMA MFG

ALL APIs

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01

Ampicillin Trihydrate

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

Natural Products Expo

Not Confirmed

02

Amoxicillin Trihydrate

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

Natural Products Expo

Not Confirmed

Amoxicillin Trihydrate

China

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

Natural Products Expo

Not Confirmed

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USDMF

CEP/COS

JDMF

EU-WC NDC KDMF

VMF Others AUDIT

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

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USDMF

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CEP/COS

01

Amoxicillin sodium, Sterile

CEP/COS

CEP/COS

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JDMF

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KDMF

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LISTED APIs

Zhuhai United Laboratories Co ., Ltd.

CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL

Product
Web Link

Stock Recap
#PipelineProspector

Market
Place

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, 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.

01

CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL

China

Natural Products Expo

Not Confirmed

CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLUL

China

Natural Products Expo

Not Confirmed

Zhuhai United Laboratories Co ., Ltd.

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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Zhuhai United Laboratories Co ., Ltd is a supplier offers 15 products (APIs, Excipients or Intermediates).

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Company profile for Zhuhai United Laboratories Co ., Ltd.

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EVENTS

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma

Vlog #PharmaReel

Data Compilation #PharmaFlow

5 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

20 All APIs

13 USDMF

11 CEP/COS

3 JDMF

28 KDMF

1 Listed APIs

INSPECTIONS & REGISTRATIONS

2 FDA

4 EDQM

1 GDUFA

01

02

03

04

05

06

07

08

09

10

Valid

R1-CEP 2013-125 - Rev 03

Chemical

2023-03-15

577

01

Valid

CEP 2024-327 - Rev 00

Chemical

2024-11-26

577

02

Valid

CEP 2007-191 - Rev 04

Chemical

2025-01-29

260

03

Valid

CEP 2006-039 - Rev 03

Chemical

2025-01-27

260

04

Valid

CEP 2010-090 - Rev 04

Chemical

2024-07-09

168

05

Withdrawn by Holder

R1-CEP 2010-184 - Rev 01

Chemical

2018-10-26

2020-09-09

1408

06

Withdrawn by Holder

R1-CEP 2010-163 - Rev 01

Chemical

2018-10-26

2020-09-09

1226

07

Valid

R1-CEP 2015-083 - Rev 00

Chemical