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    Company profile for Zhejiang Tianyu Pharmaceutical Co., Ltd

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    About

    Founded in 2003, Zhejiang Tianyu Pharmaceutical Co., Ltd. is a joint-stock pharmaceutical company specializing in the research, development and manufacture of APIs and advanced pharmaceutical intermediates. The company has a registered capital of 120 million yuan and covers an area of ​​700 mu. The factory has more than 2,600 employees.

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    Zhejiang Tianyu Pharmaceutical Co., LtdChina Flag
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    Country
    China
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    Address
    Jiangkou Development Zone, Huangyan
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    Telephone
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    Email
    enquiries@pharmacompass.com
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    Website
    http://www.tianyupharm.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?  Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands?  At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

    Impressions: 2606

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    https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence

    PharmaCompass
    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaVersatile Source for Prostaglandin APIsVersatile Source for Prostaglandin APIs

    Versatile Source for Prostaglandin APIs
    Versatile Source for Prostaglandin APIs

    reelVersatile Source for Prostaglandin APIs

    This PharmaReel spotlights Cayman Pharma’s expertise in Prostaglandin APIs, backed by Czech NCA (SUKL, USKVBL) and USFDA approvals. With patented technology, process excellence, and quality focus, Cayman is a trusted partner for reliable CDMO services.

    Impressions: 7688

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  
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    Impressions: 2012

    https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-24-in-h1-2025-gsk-s-uti-med-vertex-s-non-opioid-painkiller-lead-pack-of-first-in-class-meds

    #PharmaFlow by PHARMACOMPASS
    28 Aug 2025
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    NEWS #PharmaBuzz

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    FDA Issues Form 483 to Zhejiang Tianyu Pharma
    FDA Issues Form 483 to Zhejiang Tianyu Pharma

    14 Jan 2025

    // FDA

    https://www.fda.gov/media/185102/download

    FDA
    14 Jan 2025
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    Zhejiang Tianyu Pharmaceutical Co. Limited on Health Canada Inspection List
    Zhejiang Tianyu Pharmaceutical Co. Limited on Health Canada Inspection List

    07 Dec 2022

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/zhejiang-tianyu-pharmaceutical-co-limited-on-health-canada-inspection-list-48637.pdf

    HEALTH CANADA
    07 Dec 2022
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    The FDA scolds Tianyu over repeat API production shortfalls
    The FDA scolds Tianyu over repeat API production shortfalls

    29 Sep 2022

    // Fraiser Kansteiner FIERCEPHARMA

    https://www.fiercepharma.com/manufacturing/fda-blasts-chinese-drug-ingredients-outfit-subpar-impurity-testing-and-poor-equipment

    Fraiser Kansteiner FIERCEPHARMA
    29 Sep 2022
    Share Share
    Zhejiang Tianyu Pharmaceutical Co., Ltd. Receives FDA Warning Letter
    Zhejiang Tianyu Pharmaceutical Co., Ltd. Receives FDA Warning Letter

    28 Sep 2022

    // FDA

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-tianyu-pharmaceutical-co-ltd-631054-08172022

    FDA
    28 Sep 2022
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    Manufacturing sites in Germany & China hit with warning letters
    Manufacturing sites in Germany & China hit with warning letters

    27 Sep 2022

    // Tyler Patchen ENDPTS

    https://endpts.com/manufacturing-sites-in-germany-and-china-hit-with-warning-letters-over-qc-and-cleaning-issues/

    Tyler Patchen ENDPTS
    27 Sep 2022
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    EU, US Ban Manufacturer use of Valsartan From China’s Zhejiang Huahai
    EU, US Ban Manufacturer use of Valsartan From China’s Zhejiang Huahai

    29 Sep 2018

    // Ana Mulero RAPS

    https://www.raps.org/news-and-articles/news-articles/2018/9/eu-us-ban-manufacturer-use-of-valsartan-from-chin?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2028%20September

    Ana Mulero RAPS
    29 Sep 2018
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Olmesartan Medoxomil

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Olmesartan Medoxomil

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-08-29

    Pay. Date : 2018-04-10

    DMF Number : 31888

    Submission : 2018-02-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-268 - Rev 03

    Issue Date : 2025-03-06

    Type : Chemical

    Substance Number : 2600

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10072

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2022-05-12

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2025-03-11

    Registration Number : 163-42-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou City

     VMF Others AUDIT
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    Product
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    Market
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    02

    Rivaroxaban

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Rivaroxaban

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39681

    Submission : 2024-03-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-330 - Rev 01

    Issue Date : 2023-03-23

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 307MF10047

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2025-04-02

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2024-09-05

    Registration Number : Su289-20-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou City, Zhejiang, China

     VMF Others AUDIT
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    Market
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    03

    Valsartan

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Valsartan

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-07-23

    Pay. Date : 2018-03-05

    DMF Number : 32175

    Submission : 2017-12-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-159 - Rev 02

    Issue Date : 2021-07-23

    Type : Chemical

    Substance Number : 2423

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10079

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2024-06-12

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Narsha Farm Co., Ltd.

    Registration Date : 2025-06-26

    Registration Number : 20150918-135-H-305-43(2)-A(4)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Zhejiang

     VMF Others AUDIT
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    04

    Valsartan

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Valsartan

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-05-03

    Pay. Date : 2019-01-28

    DMF Number : 33475

    Submission : 2018-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-389 - Rev 04

    Issue Date : 2025-03-05

    Type : Chemical

    Substance Number : 2423

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10107

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2014-05-21

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2025-04-30

    Registration Number : 20150918-135-H-305-43(2)-A(3)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Zhejiang

     VMF Others AUDIT
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    05

    Losartan Potassium

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Losartan Potassium

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18780

    Submission : 2005-08-22

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-227 - Rev 07

    Issue Date : 2024-03-20

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 307MF10041

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, China

    Initial Date of Registration : 2025-02-26

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2019-06-26

    Registration Number : 20100616-122-G-60-22(12)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd

    Manufacturer Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang, China

     VMF Others AUDIT
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    Product
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    06

    Montelukast Sodium

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Montelukast Sodium

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26097

    Submission : 2012-05-26

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-115 - Rev 01

    Issue Date : 2021-07-16

    Type : Chemical

    Substance Number : 2583

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10094

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2017-05-16

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Sanil Pharma Co., Ltd.

    Registration Date : 2025-03-11

    Registration Number : 20220512-209-J-1243(1)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou City, Zhejiang Province, China

     VMF Others AUDIT
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    07

    Ezetimibe

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Ezetimibe

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-12-29

    Pay. Date : 2021-10-29

    DMF Number : 32716

    Submission : 2021-09-22

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10070

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2023-06-07

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Medipoem Co., Ltd.

    Registration Date : 2025-04-02

    Registration Number : No. 695-9-ND(2)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou City, Zhejiang, Province, China

     VMF Others AUDIT
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    08

    Losartan Potassium

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Losartan Potassium

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-12-09

    Pay. Date : 2014-09-12

    DMF Number : 28346

    Submission : 2014-05-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-288 - Rev 01

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2018-06-14

    Registration Number : 20100616-122-G-60-22(11)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co.,Ltd.

    Manufacturer Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang

     VMF Others AUDIT
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    09

    Losartan Potassium

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Losartan Potassium

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-11-16

    Pay. Date : 2021-09-08

    DMF Number : 36226

    Submission : 2021-08-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-320 - Rev 00

    Issue Date : 2022-03-21

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2015-02-15

    Registration Number : 20100616-122-G-60-22(9)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang, China

     VMF Others AUDIT
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    10

    Montelukast Sodium

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

    CPHI Shenzhen
    Not Confirmed
    arrow

    Montelukast Sodium

    China

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

    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-07-31

    Pay. Date : 2018-04-10

    DMF Number : 32307

    Submission : 2018-03-24

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 306MF10051

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republic of China 318020

    Initial Date of Registration : 2024-04-03

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Otran Korea Co., Ltd.

    Registration Date : 2022-05-12

    Registration Number : 20220512-209-J-1243

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou City, Zhejiang, Province, China

     VMF Others AUDIT
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    KDMF

    read-more
    read-more

    01

    Apixaban

    China
    CPHI Shenzhen
    Not Confirmed
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    Apixaban

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Toru Corporation

    Registration Date : 2024-06-28

    Registration Number : Su651-2-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

    blank

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    02

    Azilsartan

    China
    CPHI Shenzhen
    Not Confirmed
    arrow

    Azilsartan

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Sampoong Pharmachem Co., Ltd.

    Registration Date : 2025-03-05

    Registration Number : 582-24-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    03

    Azilsartan medoxomil potassium

    China
    CPHI Shenzhen
    Not Confirmed
    arrow

    Azilsartan medoxomil potassium

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Toru Corporation

    Registration Date : 2025-04-02

    Registration Number : No. 651-8-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

    blank

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    04

    Candesartan cilexetil

    China
    CPHI Shenzhen
    Not Confirmed
    arrow

    Candesartan cilexetil

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2020-07-07

    Registration Number : 20200707-209-J-471

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    05

    Dabigatran etexilate mesylate

    China
    CPHI Shenzhen
    Not Confirmed
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    Dabigatran etexilate mesylate

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
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    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2025-01-23

    Registration Number : Su289-25-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    06

    Dapagliflozin propanediol hydrate

    China
    CPHI Shenzhen
    Not Confirmed
    arrow

    Dapagliflozin propanediol hydrate

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Sampoong Pharmachem Co., Ltd.

    Registration Date : 2023-05-02

    Registration Number : Su582-11-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    Market
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    07

    Dapagliflozin propanediol hydrate

    China
    CPHI Shenzhen
    Not Confirmed
    arrow

    Dapagliflozin propanediol hydrate

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2024-04-03

    Registration Number : No. 582-11-ND(1)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5thAvenue, Zhejiang Provincial Chemical and Medical Raw Materials Base...

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    08

    Empagliflozin

    China
    CPHI Shenzhen
    Not Confirmed
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    Empagliflozin

    China
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    CPHI Shenzhen
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2024-12-16

    Registration Number : Su331-25-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    09

    Ezetimibe

    China
    CPHI Shenzhen
    Not Confirmed
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    Ezetimibe

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
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    • EDQM
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Otran Korea Co., Ltd.

    Registration Date : 2022-06-29

    Registration Number : No. 695-9-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    10

    Ezetimibe

    China
    CPHI Shenzhen
    Not Confirmed
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    Ezetimibe

    China
    arrow
    CPHI Shenzhen
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registrant Name : Medipoem Co., Ltd.

    Registration Date : 2025-04-02

    Registration Number : No. 695-9-ND(2)

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical...

    Manufacturer Address : No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Bas...

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    Contact Zhejiang Tianyu Pharmaceutical Co., Ltd and get a quotation

    Zhejiang Tianyu Pharmaceutical Co., Ltd is a supplier offers 73 products (APIs, Excipients or Intermediates).

    Find a price of Olmesartan Medoxomil bulk with DMF, CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Rivaroxaban bulk with DMF, CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Valsartan bulk with DMF, CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Losartan Potassium bulk with CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Montelukast Sodium bulk with CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Azilsartan bulk with DMF, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Candesartan Cilexetil bulk with CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Ezetimibe bulk with DMF, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Irbesartan bulk with CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Losartan Potassium bulk with DMF, CEP offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Montelukast Sodium bulk with DMF, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Apixaban bulk with DMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Azilsartan bulk with JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Brivaracetam bulk with CEP offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Dabigatran Etexilate Mesylate bulk with CEP offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Dapagliflozin bulk with DMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Edoxaban Tosylate bulk with DMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Nicorandil bulk with CEP offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Sacubitril Sodium bulk with DMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Silodosin bulk with JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Sitagliptin Phosphate bulk with CEP offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of CAS 482577-59-3 bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Acalabrutinib bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Apalutamide bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Canagliflozin bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of CAS 654671-77-9 bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Dapagliflozin Propanediol Monohydrate bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Dolutegravir Sodium bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Elagolix Sodium bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Empagliflozin bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Enzalutamide bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Ezetimibe bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Febuxostat bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Giredestrant bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Ibrutinib bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Irbesartan bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Lasmiditan bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Lifitegrast bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Losartan Potassium bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Lumateperone Tosylate bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Lurasidone Hydrochloride bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Mirogabalin Besylate bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Olmesartan Medoxomil bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Perampanel bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Pregabalin bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Pyrotinib bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Roxadustat bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Sacubitril-Valsartan bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Tafluprost bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    Find a price of Valsartan bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Venetoclax bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Vitamin D bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Vonoprazan Fumarate bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Zavegepant HCl bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

    Find a price of Ezetimibe (undifferentiated) bulk offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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