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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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    China
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    Jiangkou Development Zone, Huangyan
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    enquiries@pharmacompass.com
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    http://www.tianyupharm.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health. HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs? Inke has established itself as a global leader in generic respiratory API development through our unique blend  of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies. The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities. Our end-to-end approach, from early-stage API development to commercial-scale production, ensures that we maintain the highest standards of quality, safety, and efficacy. As the market for respiratory APIs continues to evolve, Inke remains committed to expanding its portfolio to address unmet therapeutic needs. Beyond respiratory APIs, we are also prioritizing growth in CNS treatments and building on our expertise in complex molecule synthesis. This strategic focus allows us to provide an integrated solution that not only meets current market demands but also anticipates future pharmaceutical trends. HIGHLIGHTS// comprehensive portfolio of inhalation therapies/ over 20 years of experience in micronization and particle engineering/ specialize in bronchodilators and other critical respiratory APIs/ prioritizing growth in CNS treatments In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs? What sets Inke apart in micronization is our advanced particle size reduction technology and our dedication to precision. Our facility is equipped with various milling techniques such as Cone, Jet, and Pin mills, allowing us to reduce particle size while stabilizing the amorphous content to ensure consistent quality. Our in-depth understanding of respiratory APIs, combined with our ability to tailor solutions for each customer, results in APIs with improved solubility, stability, and bioavailability, which are critical for the efficacy of inhalation products. This, along with our exceptional quality standards and a flawless audit track record, has positioned us as a key partner for major players in the inhalation market. HIGHLIGHTS// advanced particle size reduction technology/ technological innovations/ tailor solutions/ improved solubility, stability, and bioavailability Developing complex APIs can be challenging. How does Inke ensure a smooth and successful partnership throughout the development and manufacturing process, including customization, ensuring regulatory compliance and timely delivery? At Inke, we are dedicated to fostering strong partnerships with our clients through a collaborative approach that prioritizes open communication and mutual understanding. Our commitment to quality and personalized service sets us apart in the pharmaceutical landscape. Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner. We understand that navigating regulatory landscapes can be challenging. That's why our team is equipped to manage all aspects of the regulatory process with meticulous attention to detail. From the submission of Drug Master Files (DMFs) and Certificates of Suitability to crafting precise responses to potential Deficiency Letters, we ensure compliance at every step. Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile response capabilities, enables us to deliver exceptional results while maintaining transparency and trust. At Inke, we are committed to building lasting relationships that drive success for both our clients and our organization. HIGHLIGHTS// ensuring alignment with client specifications/ manage all aspects of the regulatory process/ support in patent and intellectual property matters Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions? Inke is strategically focused on expanding its footprint in the European and US markets, where we continue to prioritize our efforts. The US market remains pivotal for us, especially considering our successful FDA inspections and ongoing regulatory compliance efforts that solidify our reputation. Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market. Our strategy involves leveraging our existing capabilities to navigate regulatory landscapes and fostering strong partnerships within the region, thereby enhancing our market reach and influence in the pharmaceutical sector. HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners? At Inke, the introduction of CMO services is a natural extension of our core expertise in the development and manufacturing of high-quality generic APIs. Our expansion into CMO is part of a strategic move to diversify our service portfolio, allowing us to offer end-to-end solutions for our clients. The CMO service integrates seamlessly with our expertise in API manufacturing, particularly in micronization, which has been a key differentiator for Inke for over two decades. With our advanced particle engineering capabilities, we can offer tailored solutions that meet specific technical and regulatory requirements. Whether it is small-batch production or scaling up to commercial quantities, we offer the flexibility to accommodate a wide range of customer needs. This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint. HIGHLIGHTS// CMO is part of a strategic move to diversify our service portfolio/ deep expertise in micronization What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development? At Inke, we recognize that integrating environmental, social, and governance (ESG) principles into our operations is not just a responsibility but a pathway to long-term success. Our ESG vision is centered around aligning business growth with sustainable practices that positively impact our communities and the environment. We are dedicated to environmental responsibility, actively implementing initiatives such as efficient wastewater treatment and water reuse systems to minimize our ecological footprint. Our recent investments in energy efficiency include the installation of a 135 kWp solar panel system, which underscores our commitment to reducing emissions and resource consumption across our manufacturing and research facilities. Inke is also committed to fostering a diverse and inclusive workforce. With a notable increase in our team members, particularly in operations and quality assurance, we prioritize career development and the well-being of our employees. By adhering to high regulatory standards, we ensure our products meet stringent global requirements, enhancing our transparency and compliance. Through these initiatives, Inke aims to cultivate sustainable practices that not only support our business objectives but also contribute positively to the pharmaceutical industry and society at large. HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce

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    https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases

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    28 Oct 2024
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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    Impressions: 2508

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
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    NEWS #PharmaBuzz

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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
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    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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    EMA review of impurities in sartan medicines
    EMA review of impurities in sartan medicines

    22 Sep 2018

    // PRESS RELEASE

    https://www.pharmacompass.com/pdf/news/EMA-review-of-impurities-in-sartan-medicines-1538045187.pdf

    PRESS RELEASE
    22 Sep 2018
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    ALL APIs

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    01

    Olmesartan Medoxomil

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

    SupplySide West 2024
    Not Confirmed
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    Olmesartan Medoxomil

    China

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

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    SupplySide West 2024
    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 : R1-CEP 2013-268 - Rev 02

    Issue Date : 2022-01-07

    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 : Kyungbo Pharmaceutical Co., Ltd.

    Registration Date : 2011-11-04

    Registration Number : 459-7-ND

    Manufacturer Name : Zhejiang Tianyu Pharmaceutical Co., Ltd.

    Manufacturer Address : 174@No.15 , Silok-ro, Asan-si, Chungcheongnam -do, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou City

     VMF Others AUDIT
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    Market
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    02

    Valsartan

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Valsartan

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
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    • EDQM
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    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 : Aging Life Science Co., Ltd.

    Registration Date : 2024-05-17

    Registration Number : 20150918-135-H-305-43(B)

    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, China

     VMF Others AUDIT
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    Place

    03

    Valsartan

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Valsartan

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
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    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 : R0-CEP 2020-389 - Rev 03

    Issue Date : 2023-06-28

    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 : Aging Life Science Co., Ltd.

    Registration Date : 2024-05-17

    Registration Number : 20150918-135-H-305-43(B)

    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, China

     VMF Others AUDIT
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    04

    Montelukast Sodium

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Montelukast Sodium

    China

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

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    SupplySide West 2024
    Not Confirmed
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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 : 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 Pharm 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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    05

    Azilsartan

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Azilsartan

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39654

    Submission : 2024-03-25

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10041

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

    Initial Date of Registration : 2023-03-29

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    06

    Ezetimibe

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Ezetimibe

    China

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

    arrow
    SupplySide West 2024
    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 : Ace Biopharm Co., Ltd.

    Registration Date : 2024-01-04

    Registration Number : No. 695-9-ND(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, China

     VMF Others AUDIT
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    Market
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    07

    Losartan Potassium

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Losartan Potassium

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
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    ✖

    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 2009-227 - Rev 07

    Issue Date : 2024-03-20

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF 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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    Market
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    08

    Losartan Potassium

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Losartan Potassium

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
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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 : 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 : 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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    Market
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    09

    Montelukast Sodium

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Montelukast Sodium

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
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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 : 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 : Otran Pharm 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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    Market
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    10

    Ticagrelor

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

    SupplySide West 2024
    Not Confirmed
    arrow

    Ticagrelor

    China

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

    arrow
    SupplySide West 2024
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39569

    Submission : 2024-03-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-348 - Rev 00

    Issue Date : 2022-07-29

    Type : Chemical

    Substance Number : 3087

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    Apixaban

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    02

    Azilsartan

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    03

    Ezetimibe

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    04

    Losartan Potassium

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    05

    Losartan Potassium

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    06

    Losartan Potassium (l-3)

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    07

    Methyl N-[(2'-cyanobiphenyl-4-yl)met...

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    08

    Montelukast Backone Diol

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    09

    Montelukast Sodium

    China
    SupplySide West 2024
    Not Confirmed
    arrow

    10

    Olmesartan Medoxomil

    China
    SupplySide West 2024
    Not Confirmed
    arrow
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    CEP/COS

    read-more
    read-more

    01

    Candesartan cilexetil

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    02

    Irbesartan

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    03

    Losartan potassium

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    04

    Losartan potassium, Process-II

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    05

    Losartan potassium, Process-III

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    06

    Montelukast sodium

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    07

    Nicorandil

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    08

    Olmesartan medoxomil

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    09

    Olmesartan medoxomil, Process - II

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow

    10

    Rivaroxaban

    CEP/COS

    SupplySide West 2024
    Not Confirmed
    arrow
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    JDMF

    read-more
    read-more

    01

    Azil sartan

    JDMF

    Saudi International Expo
    Not Confirmed
    arrow

    Azil sartan

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 305MF10041

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2023-03-29

    Latest Date of Registration : 2023-03-29

    blank

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    Market
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    02

    Azilsartan

    JDMF

    Saudi International Expo
    Not Confirmed
    arrow

    Azilsartan

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 304MF10129

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2022-09-08

    Latest Date of Registration : 2022-09-08

    blank

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    Market
    Place

    03

    Candesartan cilexetil

    JDMF

    Saudi International Expo
    Not Confirmed
    arrow

    Candesartan cilexetil

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 227MF10168

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2015-06-18

    Latest Date of Registration : 2022-08-17

    blank

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    Market
    Place

    04

    Ezetimibe

    JDMF

    Saudi International Expo
    Not Confirmed
    arrow

    Ezetimibe

    China
    arrow
    Saudi International Expo
    Not Confirmed
    • fda
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 305MF10070

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2023-06-07

    Latest Date of Registration : 2023-06-07

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    Market
    Place

    05

    Irbesartan

    JDMF

    Saudi International Expo
    Not Confirmed
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    Irbesartan

    China
    arrow
    Saudi International Expo
    Not Confirmed
    • fda
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 304MF10158

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

    Initial Date of Registration : 2022-12-23

    Latest Date of Registration : 2022-12-23

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    Market
    Place

    06

    Irbesartan "production-only"

    JDMF

    Saudi International Expo
    Not Confirmed
    arrow

    Irbesartan "production-only"

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 229MF10089

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

    Initial Date of Registration : 2017-05-01

    Latest Date of Registration : 2021-06-07

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    Market
    Place

    07

    Montelukast Sodium

    JDMF

    Saudi International Expo
    Not Confirmed
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    Montelukast Sodium

    China
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    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 306MF10051

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2024-04-03

    Latest Date of Registration : 2024-04-03

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    Market
    Place

    08

    Montelukast sodium

    JDMF

    Saudi International Expo
    Not Confirmed
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    Montelukast sodium

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 229MF10094

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2017-05-16

    Latest Date of Registration : 2020-07-22

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    Market
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    09

    Olmesartan Medoxomil

    JDMF

    Saudi International Expo
    Not Confirmed
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    Olmesartan Medoxomil

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 304MF10072

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2022-05-12

    Latest Date of Registration : 2022-05-12

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    Market
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    10

    Olmesartan medoxomil

    JDMF

    Saudi International Expo
    Not Confirmed
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    Olmesartan medoxomil

    China
    arrow
    Saudi International Expo
    Not Confirmed
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    Zhejiang Tianyu Pharmaceutical Co., Ltd

    Registration Number : 229MF10134

    Registrant's Address : Jiangkou Development Zone, Huangyan, Taizhou City, Zhejiang Province, People's Republ...

    Initial Date of Registration : 2017-07-19

    Latest Date of Registration : 2017-07-19

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

    Zhejiang Tianyu Pharmaceutical Co., Ltd is a supplier offers 65 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 Valsartan bulk with DMF, CEP, JDMF offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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

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

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    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 Sitagliptin Phosphate bulk with CEP offered by Zhejiang Tianyu Pharmaceutical Co., Ltd

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

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

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