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

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

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INTERVIEW #SpeakPharma
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ACTIVE PHARMA INGREDIENTS

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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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.

DCAT WeekDCAT Week

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17-20 March, 2025

New York, USA
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15-19 December, 2024

Marriott Marquis San Diego
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03-05 January, 2025

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

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+86-756-77876977787434

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http://zhuhai-united.en.ywsp.com/

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INTERVIEW #SpeakPharma

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“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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Full-Service Generic API Company

DATA COMPILATION #PharmaFlow

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Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17 13 37 Taiwan 9 6 5 4 24 Switzerland 15 4 4 23 France 16 6 22 Japan 18 1 19 United Kingdom 12 1 2 15 Mexico 9 1 1 11 Ireland 5 5 1 11 Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years.