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    Company profile for Zhuhai United Laboratories Co ., Ltd.

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    1. We are listed on Hong Kong Union Stock Exchange. Vertically integrated management for our six Production Bases: Finished Product Plant, HK; Bulk Medicine Plant, Zhuhai; Finished Product Plant, Zhongshan; Empty Capsule Plant, Kaiping; Intermediate Plant, Chengdu; and Intermediate Plant, Inner Mongolia 2. One of the largest antibiotic 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
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    +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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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

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    16 Dec 2024
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    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

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    20 Feb 2025
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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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