Zhuhai United Laboratories Co., Ltd. DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 5 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
5 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

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

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

INSPECTIONS & REGISTRATIONS

2 FDA, 4 EDQM, 1 GDUFA

inspections
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.

CPhI ChinaCPhI China

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Not Confirmed

24-26 June, 2025

SNIEC, Shanghai, China
IOPCIOPC

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Not Confirmed

09-11 June, 2025

Prague
Annual Outsourcing in ...Annual Outsourcing in CT

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Not Confirmed

10-11 June, 2025

Park Lane, UK

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

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INTERVIEW #SpeakPharma

[Sponsored by another company]

Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 1138

VLOG #PharmaReel

[Sponsored by another company]

Your Biologic Therapeutic Stabilization, Protection & Delivery Partner

This PharmaReel highlights Pfanstiehl's portfolio, featuring highest-purity, low-endotoxin injectable-grade excipients, generic APIs and intermediates, HPAPIs, and modified carbohydrates. The company provides API custom synthesis and ADC linker manufacturing services, all backed by USFDA certification.

Impressions: 348

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

The pharmaceutical excipients market saw significant strategic consolidations, technological developments, and regulatory adaptations in 2025. Globally, the pharmaceutical excipients sector is growing at a compound annual growth rate of 6.6 percent, and was valued at US$ 8.85 billion in 2024. It is projected to reach US$ 14.77 billion by 2032.This year, the sector is witnessing technological advancements, regulatory evolution, and strategic business realignments. North America continues to dominate the global excipients landscape, with a 39.8 percent market share. The Asia-Pacific region is the fastest-growing segment with a substantial 30.4 percent market share, driven by increasing investments in pharmaceutical manufacturing, growing demand for cost-effective drugs, and rising healthcare expenditure across developing economies.Major excipient providers include BASF, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, DuPont, Evonik, Seqens, Actylis, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Kewpie Corporation, Boai NKY Pharmaceuticals, ICE Pharma, Roquette, Nanjing Well Pharmaceutical, Minakem, Ashland Global, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Roquette restructures after buying IFF Pharma; Colorcon partners ASHA CelluloseIn May, Roquette completed its acquisition of IFF Pharma Solutions. Valued at up to US$ 2.85 billion in enterprise value, this transaction represents a major consolidation in the pharmaceutical excipients market. The acquisition significantly enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide. Roquette announced a comprehensive, new organizational structure following the acquisition, indicating the company’s commitment to integrate IFF Pharma Solutions’ capabilities seamlessly into its existing operations. This consolidation creates a more robust platform for addressing the growing demand for specialized excipients in complex drug formulations, particularly as the industry moves towards more personalized approaches to medicines.So far, the year has also witnessed some strategic alliances, such as Colorcon’s partnership with ASHA Cellulose. As part of the deal, Colorcon will become the exclusive representative for two ASHA products — ASHACEL and ASHAKOTE — throughout Europe, the Middle East, Africa, Northeast Asia and Southeast Asia.Brenntag Specialties has announced an exclusive distribution agreement with MEGGLE Excipients to expand market reach. This collaboration makes available a broad portfolio of over 30 high-quality lactose-based excipients for various applications in the pharmaceutical industries across the Netherlands, Belgium, Norway, Finland, and Sweden.The portfolio’s versatility offers optimal solutions for a wide range of pharmaceutical applications, including tableting through both granulation and direct compression, powder preparations, and dry powder inhalation. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)WHO, FDA drive new standards with GMP guidelines; Pfanstiehl launches injectable-grade glycineIn March, the World Health Organization had put out a publication titled “Good Manufacturing Practices for Excipients used in Pharmaceutical Products.” WHO’s excipient GMP guideline emphasizes modern quality management principles, comprehensive risk assessment protocols, and supplier qualification procedures for excipients across all stages of production, storage, and distribution.Meanwhile, the US Food and Drug Administration (FDA) has proposed amendments to the Food, Drug, and Cosmetic Act as part of its FY 2025 legislative proposals, specifically targeting supply chain transparency for high-risk excipients. The FDA proposal would require certain excipients designated as high-risk to carry labeling that identifies the original manufacturer’s name and address. This initiative addresses what FDA has identified as a lack of transparency in excipient supply chains.In April, IFF Pharma Solutions launched Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC). This innovative product is specifically designed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages, addressing one of the most pressing concerns in contemporary pharmaceutical manufacturing.Pfanstiehl, a global leader in high-purity excipient manufacturing, announced the launch of its High Purity Low Endotoxin Low Metals (HPLE-LM) injectable-grade glycine. This multi-compendial glycine is specifically engineered for use in biologics, vaccines, and the downstream purification of monoclonal antibodies (mAbs). Manufactured under ICH-Q7 cGMP regulations at Pfanstiehl’s advanced facility in Waukegan, Illinois, the product meets stringent global pharmacopeial standards. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Shin-Etsu Chemical invests in Japan, Germany to expand cellulose productionIn March, Shin-Etsu Chemical announced investments in pharmaceutical cellulose business operations in Japan and Europe, thereby showing significant commitment to market expansion. The company is making substantial investments at two key bases: the subsidiary SE Tylose GmbH in Germany, and the Naoetsu Plant in Joetsu, Japan. In Germany, a new production facility for the pharmaceutical excipient L-HPC will be built adjacent to the existing facility, creating a dual base with the Naoetsu Plant. The excipients market in 2025 has seen innovation in functional applications. Research on BENEO’s Palatinose as a bedtime drink shows that it improves aspects of sleep and represents an innovative approach to excipient functionality. Palatinose is a naturally sourced, smart carbohydrate that provides full carbohydrate energy in a more balanced way, thanks to its low-glycemic profile.Gangwal Healthcare, with its EXCiPACT-certified GMP facilities and a robust portfolio of co-processed excipients like ProBlend, Starlose, and Microlose, is actively contributing to the pharmaceutical industry’s demand for functional excipients. The company also offers cellulose-based excipients such as Solvostar (Sodium Starch Glycolate) and Sallyso (Croscarmellose Sodium), designed to improve tablet disintegration and drug release profiles in oral solid dosage forms.Evonik announced a partnership with South Korea–based CDMO ST Pharm to expand its RNA and nucleic acid delivery services. This collaboration enables Evonik to integrate customized nucleic acids from ST Pharm seamlessly with its lipid and lipid nanoparticle (LNP) development and fill-and-finish services. This streamlined approach means that pharmaceutical companies can reduce complexity and increase speed-to-market for nucleic acid therapeutics. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Our viewThe pharmaceutical excipients market in 2025 is being shaped by several key trends including the development of multifunctional excipients that can simultaneously improve solubility, bioavailability, and control drug release in increasingly complex formulations.Moreover, the expanding generic medicines market is creating demand for cost-effective, versatile excipients. The growing importance of biologics and biosimilars is driving innovation in specialized excipients designed to maintain the stability and efficacy of these complex therapeutic products throughout their lifecycle. And nanotechnology continues to enable advanced nano-excipients for enhanced drug delivery and efficacy.In addition to these trends, we also notice a shift towards natural and plant-based excipients that is driven by sustainability concerns and potential biocompatibility benefits.