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    Company profile for ChemWerth Inc

    ChemWerth-PSE
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    PharmaTech Outlook Names ChemWerth as a Top Drug Discovery of 2023

    24 May 2023

    // PRESS RELEASE

    ChemWerth Names New CEO

    18 Jun 2024

    // PRESS RELEASE

    Supply Chain Security If Your API Supply Is Important

    05 Sep 2023

    // PRESS RELEASE

    PharmaTech Outlook Names ChemWerth as a Top Drug Discovery of 2023

    24 May 2023

    // PRESS RELEASE

    ChemWerth Names New CEO

    18 Jun 2024

    // PRESS RELEASE

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    Latest Content by PharmaCompass

    speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    About

    Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.

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    ChemWerth IncUnited_States_of_America Flag
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    U.S.A
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    1764 Litchfield Turnpike Woodbridge, CT 06525
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    +1 2033877794
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    jon.moore@chemwerth.com
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    https://chemwerth.com/
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    http://www.youtube.com/@ChemWerth
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    ChemWerth Pharmaceutical Technology Co., Ltd. (China)

    20 Floor, BIO Building,
    No. 1326 YanAn Road (West),
    Shanghai 200052 China

    021-52585258

    Email ID:
    chinaoffice@chemwerth.com

     

    ChemWerth (India)

    B-604, 6th Floor
    The Platina
    Near Radisson Hotel
    Gachibowli
    Hyderabad 500 032

    Email ID:
    sales@chemwerth.com

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    INTERVIEW #SpeakPharma

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    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

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    Corporate Presentation

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    Products Under Development 2025

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    Nitrosamine & Genotoxic Impurity 2025

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    The ChemWerth Advantage 2025

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    ChemWerth Celebrates 40 Years in Business

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    A New Look at ANDA Approvals

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    NEWS #PharmaBuzz

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    ChemWerth Names New CEO
    ChemWerth Names New CEO

    18 Jun 2024

    // PRESS RELEASE

    https://chemwerth.com/announcement-of-leadership-changes/

    PRESS RELEASE
    18 Jun 2024
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    Supply Chain Security If Your API Supply Is Important
    Supply Chain Security If Your API Supply Is Important

    05 Sep 2023

    // PRESS RELEASE

    https://chemwerth.com/supply-chain-security-if-your-api-supply-is-important-you-should-take-5-minutes-to-read-this/

    PRESS RELEASE
    05 Sep 2023
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    PharmaTech Outlook Names ChemWerth as a Top Drug Discovery of 2023
    PharmaTech Outlook Names ChemWerth as a Top Drug Discovery of 2023

    24 May 2023

    // PRESS RELEASE

    https://chemwerth.com/pharmatech-outlook-names-chemwerth-as-a-top-drug-discovery-and-development-company-of-2023-2/

    PRESS RELEASE
    24 May 2023
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    Peter Werth Recieves Honorary Degree From Housatonic Community College
    Peter Werth Recieves Honorary Degree From Housatonic Community College

    23 May 2023

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    https://chemwerth.com/peter-werth-recieves-honorary-degree-from-housatonic-community-college/

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    23 May 2023
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    Woodbridge Pharma Company ChemWerth Eyes Overseas Expansion
    Woodbridge Pharma Company ChemWerth Eyes Overseas Expansion

    21 May 2023

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    https://chemwerth.com/woodbridge-pharma-company-chemwerth-eyes-overseas-expansion/

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    21 May 2023
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    ChemWerth Opens Distribution in Mexico and Central America
    ChemWerth Opens Distribution in Mexico and Central America

    18 Apr 2023

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    https://chemwerth.com/chemwerth-opens-distribution-in-mexico-and-central-america/

    PRESS RELEASE
    18 Apr 2023
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    ALL APIs

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    01

    Foscarnet Sodium

    U.S.A

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

    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-07-10

    Pay. Date : 2015-02-05

    DMF Number : 28996

    Submission : 2015-01-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-337 - Rev 00

    Issue Date : 2023-02-14

    Type : Chemical

    Substance Number : 1520

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    02

    Ropivacaine Hydrochloride

    U.S.A

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

    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-13

    Pay. Date : 2013-08-05

    DMF Number : 20249

    Submission : 2007-02-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-198 - Rev 00

    Issue Date : 2023-08-28

    Type : Chemical

    Substance Number : 2335

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    03

    Argatroban Monohydrate

    U.S.A

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

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    CPhI North America
    Attending
    • fda
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-27

    Pay. Date : 2019-12-20

    DMF Number : 20709

    Submission : 2007-07-20

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    04

    Disodium Pamidronate Pentahydrate

    U.S.A

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

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    CPhI North America
    Attending
    • fda
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-24

    Pay. Date : 2012-11-19

    DMF Number : 12803

    Submission : 1997-12-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    05

    Epinastine Hydrochloride

    U.S.A

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

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    CPhI North America
    Attending
    • fda
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    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21974

    Submission : 2008-12-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    06

    Esmolol Hydrochloride

    U.S.A

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

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    CPhI North America
    Attending
    • fda
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-18

    Pay. Date : 2012-12-17

    DMF Number : 16053

    Submission : 2002-06-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    #PipelineProspector

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    07

    Etomidate

    U.S.A

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

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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-24

    Pay. Date : 2013-06-13

    DMF Number : 20500

    Submission : 2007-04-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    08

    Melphalan

    U.S.A

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

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    CPhI North America
    Attending
    • fda
    • EDQM
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21237

    Submission : 2008-01-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    09

    Milrinone

    U.S.A

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

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    CPhI North America
    Attending
    • fda
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    Pay. Date : 2013-08-13

    DMF Number : 13195

    Submission : 1998-09-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    Stock Recap
    #PipelineProspector

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    10

    Nicardipine Hydrochloride

    U.S.A

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

    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19552

    Submission : 2006-06-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Chemwerth Compnay Banner

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    Stock Recap
    #PipelineProspector

    Market
    Place

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    USDMF

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    01

    Argatroban Hydrate (non-sterile Bulk...

    U.S.A
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    ChemWerth Inc

    GDUFA

    DMF Review : Complete

    Rev. Date : 2019-12-27

    Pay. Date : 2019-12-20

    DMF Number : 20709

    Submission : 2007-07-20

    Status : Active

    Type : II

    Chemwerth Compnay Banner

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    #PipelineProspector

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    02

    Arsenic Trioxide

    U.S.A
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    ChemWerth Inc

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-02-06

    Pay. Date : 2014-04-07

    DMF Number : 26075

    Submission : 2012-05-18

    Status : Active

    Type : II

    Chemwerth Compnay Banner

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    03

    Azacitidine

    U.S.A
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    ChemWerth Inc

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-01-26

    Pay. Date : 2022-12-16

    DMF Number : 23416

    Submission : 2009-12-22

    Status : Active

    Type : II

    Chemwerth Compnay Banner

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    04

    Bromfenac Sodium (sesquihydrate)

    U.S.A
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    ChemWerth Inc

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-17

    Pay. Date : 2013-07-09

    DMF Number : 24521

    Submission : 2011-05-20

    Status : Active

    Type : II

    Chemwerth Compnay Banner

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    Web Link

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    05

    Clevidipine

    U.S.A
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    ChemWerth Inc

    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-08-04

    Pay. Date : 2020-06-23

    DMF Number : 34556

    Submission : 2020-06-01

    Status : Active

    Type : II

    Chemwerth Compnay Banner

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    Stock Recap
    #PipelineProspector

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    06

    Dexmedetomidine Hcl

    U.S.A
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    ChemWerth Inc

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-03-27

    Pay. Date : 2012-12-17

    DMF Number : 24202

    Submission : 2011-12-15

    Status : Active

    Type : II

    Chemwerth Compnay Banner

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    Dronedarone Hydrochloride Non-steril...

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-11-01

    Pay. Date : 2013-05-07

    DMF Number : 26479

    Submission : 2013-05-02

    Status : Active

    Type : II

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    08

    Eltrombopag Olamine

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    DMF Review : Complete

    Rev. Date : 2022-10-25

    Pay. Date : 2022-09-28

    DMF Number : 37269

    Submission : 2022-08-29

    Status : Active

    Type : II

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    Epinastine Hcl

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21974

    Submission : 2008-12-30

    Status : Active

    Type : II

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    10

    Esmolol Hcl

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    DMF Review : Complete

    Rev. Date : 2013-01-18

    Pay. Date : 2012-12-17

    DMF Number : 16053

    Submission : 2002-06-27

    Status : Active

    Type : II

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    Only 10 entries up to this point, click to access all click full view read-more
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    CEP/COS

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    Foscarnet sodium hexahydrate

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    Certificate Numbers : R0-CEP 2020-337 - Rev 00

    Status : Valid

    Issue Date : 2023-02-14

    Type : Chemical

    Substance Number : 1520

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    Ropivacaine hydrochloride monohydrate

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    Certificate Numbers : R0-CEP 2022-198 - Rev 00

    Status : Valid

    Issue Date : 2023-08-28

    Type : Chemical

    Substance Number : 2335

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    03

    Tobramycin, Form I

    U.S.A
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    Certificate Numbers : R1-CEP 2006-188 - Rev 02

    Status : Withdrawn by Holder

    Issue Date : 2018-10-12

    Type : Chemical

    Substance Number : 645

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    KEY PRODUCTS

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    GDUFA

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    GDUFA fees paid

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    Paid in : 2022

    ChemWerth Inc

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Sichuan Credit Chemwerth Pharm...

    Business Address : Industrial Park, Fuji Town, ...

    FEI Number : 3006168710

    Country : U.S.A

    Paid in : 2022

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    ABOUT THIS PAGE

    Contact ChemWerth Inc and get a quotation

    ChemWerth Inc is a supplier offers 108 products (APIs, Excipients or Intermediates).

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