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    Company profile for F.I.S. Fabbrica Italiana Sintetici

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    xyz-pharma-m-2025-03-24

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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    xyz-pharma-m-2025-03-17

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    About

    F.I.S. – Fabbrica Italiana Sintetici is a private Italian company that specializes in API production. Custom Synthesis is our core business, which means the exclusive production of intermediates, advanced intermediates and APIs for pharmaceutical companies who will own the NDA. FIS has the capability to provide a wide array of integrated services to the customer, including process research and development, optimization, and ...
    F.I.S. – Fabbrica Italiana Sintetici is a private Italian company that specializes in API production. Custom Synthesis is our core business, which means the exclusive production of intermediates, advanced intermediates and APIs for pharmaceutical companies who will own the NDA. FIS has the capability to provide a wide array of integrated services to the customer, including process research and development, optimization, and scale-up facilities to support both validation and commercial launch. FIS also develops and sells a wide range of Generic APIs including anxiolytics, anticonvulsants, antidepressants, analgesics, etc.

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    F.I.S. Fabbrica Italiana SinteticiItaly Flag
    Country
    Country
    Italy
    Address
    Address
    Viale Milano, 26, 36075 Montecchio, Maggiore, Vicenza (Italy)
    Telephone
    Telephone
    +39-044-470-8011
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.fisvi.com/it
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “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 

    Impressions: 794

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    https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

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    12 Mar 2025
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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Molecular glue degraders: Lilly, AbbVie sign billion-dollar deals; BMS leads with three late-stage drugs

    Molecular glue degraders: Lilly, AbbVie sign billion-dollar deals; BMS leads with three late-stage drugs

    This week, we delve into molecular glue degraders (MGDs), one of the most promising frontiers in drug development. MGDs address a vast number of previously “undruggable” disease-causing proteins.Unlike traditional small molecule drugs that require specific binding pockets, MGDs function by enhancing protein-protein interactions. MGDs selectively target disease-causing proteins and an enzyme known as E3 ubiquitin ligase. By creating a binding interface between the two, MGDs  destroy the target proteins.Another kind of degraders are proteolysis targeting chimeras (PROTACs) that use a bifunctional approach — one binds the target proteins, and the other binds to an E3 ligases together. These degraders induce the degradation of specific proteins by using the cell’s natural ubiquitin-proteasome system (a process in cells where damaged or unneeded proteins are tagged by a small molecule called ubiquitin and then broken down by a structure called the proteasome so that cells stay healthy and function properly).MGDs constitute a rapidly growing market, where both the targeted protein degradation technologies and investment in research and development are witnessing growth.Currently, the most recognized molecular glues are the immunomodulatory imide drugs (IMiDs), such as thalidomide, lenalidomide and pomalidomide, which have been around for some time. According to GlobalData, lenalidomide generated over US$ 6 billion in sales in 2023, thereby demonstrating the commercial viability of this therapeutic approach.Lilly, AbbVie ink billion-dollar MGD deals; Biogen partners Neomorph; Pfizer, Triana ink collaborationThe MGD space has witnessed extraordinary deal-making activity over the recent months, with major pharmaceutical companies committing billions of dollars to secure access to novel MGD platforms and pipelines. This surge in investment reflects the industry’s growing confidence in the therapeutic potential of MGDs to address previously undruggable targets.This year has already seen two landmark deals. In February, Magnet Biomedicine entered into a collaboration and license agreement with Eli Lilly worth up to US$ 1.29 billion to discover and develop novel MGDs. This partnership leverages Magnet’s TrueGlue discovery platform and approach with Lilly’s expertise in the development of small molecule therapeutics. In January, AbbVie crafted a US$ 1.64 billion deal with molecular glue biotech Neomorph, combining AbbVie’s oncology and immunology drug development capabilities with Neomorph's leading molecular glue discovery platform.While oncology remains the primary focus, these collaborations are increasingly expanding into neurodegenerative diseases, immunological disorders, and other therapeutic areas. For instance, in October, Biogen and Neomorph announced a multi-target research collaboration to discover and develop MGDs for Alzheimer’s, rare neurological, and immunological diseases, potentially worth up to US$ 1.45 billion.October also saw Novartis sign a potential US$ 2.25 billion deal with Monte Rosa Therapeutics. The deal gives Novartis exclusive worldwide rights to develop, manufacture and commercialize multiple MGDs (including MRT-6160) for undruggable targets, including in the areas of immunology and inflammation, metabolism, and genetic diseases.Earlier in October, Triana Biomedicines and Pfizer entered into a research collaboration to discover novel MGDs for multiple targets across several disease areas, including oncology, with a total potential value of up to US$ 1.55 billion.And in August 2024, SEED Therapeutics entered into a strategic research collaboration with Eisai to discover and develop novel MGDs for neurodegenerative and oncological indications, potentially worth up to US$ 1.5 billion.BMS leads with three MGDs in late-stage trials; Monte Rosa’s MRT-2359 targets solid tumorsBristol Myers Squibb has established itself as a leader in the clinical development of MGDs with three products in late-stage development. These include a next-gen MGD mezigdomide (CC-92480), which is currently in phase 3 trials in combination with carfilzomib and dexamethasone for relapsed/refractory multiple myeloma. Another candidate is golcadomide, which is in late-stage clinical trials for high-risk first-line large B-cell lymphoma. And the third MGD in BMS’ portfolio is iberdomide, which has reached phase 3 development for multiple myeloma.Monte Rosa Therapeutics has made significant progress with MRT-2359, an investigational MGD that is currently in phase 1/2 clinical trials for the treatment of patients with MYC-driven solid tumors, including non-small cell lung cancer, small cell lung cancer, and high-grade neuroendocrine cancer. Myelocytomatosis or MYC is a gene which causes various solid tumors when overactive.MRT-2359 represents an important advancement in extending the molecular glue approach beyond hematological malignancies to solid tumors, which have historically proven more challenging to address with protein degradation strategies.Other significant early-stage candidates are Nested Therapeutics’ NST-628 and Plexium's PLX-4545. NST-628 relies on a novel mechanism of action in its category of RAS-MAPK inhibitors, and overcomes some traditional limitations in the treatment of cancers.PLX-4545 is Plexium’s first small molecule degrader program to enter clinical development. This potent and selective MGD of a classically undruggable transcription factor, also known as Helios (IKZF2), explores treating solid tumors. Transcription factors are proteins that regulate gene expression by binding to specific DNA sequences.Boehringer’s KRAS degrader advances PROTACs approach; Arvinas tests ARV-102 for neurodegenerative diseasesLike MGDs, PROTACs are also witnessing advancements in both R&D and dealmaking. For instance, BridGene Biosciences recently expanded its strategic collaboration with Galapagos to develop a selective oral SMARCA2 PROTAC in precision oncology. The SMARCA2 gene provides instructions for making one piece (subunit) of a group of similar protein complexes known as SWI/SNF complexes.In the clinical arena, Prelude Therapeutics announced a collaboration with Merck to evaluate PRT3789 in combination with Keytruda (pembrolizumab) in patients with SMARCA4-mutated cancers. PRT3789 is a potent and highly selective, first-in-class SMARCA2 degrader.On the molecular front, ACBI3, a novel pan-KRAS degrader developed through a collaboration between the University of Dundee and Boehringer Ingelheim, addresses a critical gap in cancer therapy by targeting 13 out of 17 prevalent KRAS mutants. KRAS mutation is a change in the KRAS gene, a common gene that can cause cancer. ACBI3’s development is a potential breakthrough for millions of cancer patients with KRAS-driven tumors.Vepdegestrant (ARV-471), a collaborative effort between Arvinas and Pfizer, remains the most advanced PROTAC candidate to date and has met its primary endpoint in a late-stage study in breast cancer patients with estrogen receptor 1 mutations.  Similarly, Arvinas’ ARV-102 became the first PROTAC to be tested in humans for neurodegenerative diseases, marking a significant milestone in addressing brain-related disorders.Our viewMGDs offer a new, and groundbreaking approach to treating cancers and various other diseases, thereby attracting substantial investments by major pharmaceutical companies. As clinical trials show encouraging results, we expect investments in the MGDs space to increase even further. 
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    Impressions: 313

    https://www.pharmacompass.com/radio-compass-blog/molecular-glue-degraders-lilly-abbvie-sign-billion-dollar-deals-bms-leads-with-three-late-stage-drugs

    #Phispers by PHARMACOMPASS
    27 Mar 2025
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    NEWS #PharmaBuzz

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    Fabbrica Italiana Sintetici (F.I.S.) Selects Kinaxis for Supply Chain Planning
    Fabbrica Italiana Sintetici (F.I.S.) Selects Kinaxis for Supply Chain Planning

    22 Aug 2023

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20230822182420/en

    BUSINESSWIRE
    22 Aug 2023
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    India woos Italian bulk drug makers to cut dependency on Chinese APIs
    India woos Italian bulk drug makers to cut dependency on Chinese APIs

    13 Aug 2015

    // Raji Reddy Kesireddy THE ECONOMIC TIMES

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/india-woos-italian-bulk-drug-makers-to-cut-dependency-on-chinese-apis/articleshow/48446172.cms

    Raji Reddy Kesireddy THE ECONOMIC TIMES
    13 Aug 2015
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    ALL APIs

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    01

    Chlordiazepoxide

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

    ASPEN
    Not Confirmed
    arrow

    Chlordiazepoxide

    Italy

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

    arrow
    ASPEN
    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 : 2017-11-16

    Pay. Date : 2017-10-26

    DMF Number : 467

    Submission : 1962-02-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-423 - Rev 02

    Issue Date : 2014-02-24

    Type : Chemical

    Substance Number : 656

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10163

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2010-06-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0129

    Start Marketing Date : 2010-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2021-05-04

    Registration Number : 20210504-209-J-978

    Manufacturer Name : FIS Fabbrica Italiana Sintetici SpA

    Manufacturer Address : Viale Milano, 26-36075 MONTECCHIO MAGGIORE (VI), Italy

     VMF Others AUDIT
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    Market
    Place

    02

    Clonazepam

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

    ASPEN
    Not Confirmed
    arrow

    Clonazepam

    Italy

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

    arrow
    ASPEN
    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 : 2015-05-04

    Pay. Date : 2015-04-21

    DMF Number : 7505

    Submission : 1988-06-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-037 - Rev 01

    Issue Date : 2022-11-23

    Type : Chemical

    Substance Number : 890

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10543

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2005-09-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0014

    Start Marketing Date : 2010-03-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Clotrimazole

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

    ASPEN
    Not Confirmed
    arrow

    Clotrimazole

    Italy

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

    arrow
    ASPEN
    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 : 2015-01-07

    Pay. Date : 2014-12-18

    DMF Number : 7548

    Submission : 1988-06-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-326 - Rev 03

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 757

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10167

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2009-07-30

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0084

    Start Marketing Date : 2010-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Inactive-api
    ✖

    VMF Number : 5981

    Submission : 2010-04-20

    Status : Inactive

    Type : II

     Others AUDIT
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    04

    Diazepam

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

    ASPEN
    Not Confirmed
    arrow

    Diazepam

    Italy

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

    arrow
    ASPEN
    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 : 2012-10-24

    Pay. Date : 2013-05-13

    DMF Number : 3164

    Submission : 1978-02-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-272 - Rev 03

    Issue Date : 2023-04-17

    Type : Chemical

    Substance Number : 22

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10542

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2005-09-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0005

    Start Marketing Date : 2010-03-29

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Furosemide

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

    ASPEN
    Not Confirmed
    arrow

    Furosemide

    Italy

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

    arrow
    ASPEN
    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 : 2015-03-16

    Pay. Date : 2015-03-11

    DMF Number : 3513

    Submission : 1979-03-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-005 - Rev 03

    Issue Date : 2014-02-24

    Type : Chemical

    Substance Number : 391

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10541

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2005-09-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0053

    Start Marketing Date : 2010-03-30

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    06

    Lorazepam

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

    ASPEN
    Not Confirmed
    arrow

    Lorazepam

    Italy

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

    arrow
    ASPEN
    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 : 2014-06-27

    Pay. Date : 2014-06-20

    DMF Number : 5027

    Submission : 1983-05-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-243 - Rev 00

    Issue Date : 2022-12-16

    Type : Chemical

    Substance Number : 1121

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10849

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2005-11-01

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48087-0076

    Start Marketing Date : 2010-04-09

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Rifaximin

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

    ASPEN
    Not Confirmed
    arrow

    Rifaximin

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15635

    Submission : 2001-09-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-085 - Rev 01

    Issue Date : 2018-10-12

    Type : Chemical

    Substance Number : 2362

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10165

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2014-09-01

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2022-04-27

    Registration Number : 20220427-209-J-1280

    Manufacturer Name : FIS Fabbrica Italiana Sintetici SPA

    Manufacturer Address : Via Dovaro, snc - 36045 Lonigo (VI), Italy

     VMF Others AUDIT
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    08

    Dorzolamide Hydrochloride

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

    ASPEN
    Not Confirmed
    arrow

    Dorzolamide Hydrochloride

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20740

    Submission : 2007-07-27

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-308 - Rev 03

    Issue Date : 2019-03-25

    Type : Chemical

    Substance Number : 2359

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10165

    Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy

    Initial Date of Registration : 2018-12-04

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52133-0031

    Start Marketing Date : 1994-12-09

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : BASH HEALTH KOREA CORP.

    Registration Date : 2023-06-08

    Registration Number : 20210916-209-J-969(A)

    Manufacturer Name : FIS Fabbrica Italiana Sintetici SpA

    Manufacturer Address : Via Dovaro, snc-36045 Lonigo (VI), Italy

     VMF Others AUDIT
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    Place

    09

    Fosfomycin Trometamol

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

    ASPEN
    Not Confirmed
    arrow

    Fosfomycin Trometamol

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10891

    Submission : 1994-04-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-289 - Rev 01

    Issue Date : 2024-10-30

    Type : Chemical

    Substance Number : 1425

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52133-0018

    Start Marketing Date : 1996-12-19

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Gabapentin

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

    ASPEN
    Not Confirmed
    arrow

    Gabapentin

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14024

    Submission : 1999-03-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-173 - Rev 00

    Issue Date : 2019-08-27

    Type : Chemical

    Substance Number : 2173

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52133-0025

    Start Marketing Date : 1992-12-30

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Alvogen Korea Co., Ltd.

    Registration Date : 2023-03-10

    Registration Number : 20120725-142-I-66-04(A)

    Manufacturer Name : FIS Fabbrica Italiana Sintetici SpA

    Manufacturer Address : Via Dovaro, snc-36045 Lonigo (VI), Italy

     VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

    read-more
    read-more

    01

    Acetylcysteine, Usp

    Italy
    ASPEN
    Not Confirmed
    arrow

    02

    Allopurinol

    Italy
    ASPEN
    Not Confirmed
    arrow

    03

    Benzyl Hydrazine Msa (fis0181)

    Italy
    ASPEN
    Not Confirmed
    arrow

    04

    Carbamazepine

    Italy
    ASPEN
    Not Confirmed
    arrow

    05

    Chlordiazepoxide Hcl

    Italy
    ASPEN
    Not Confirmed
    arrow

    06

    Clobazam

    Italy
    ASPEN
    Not Confirmed
    arrow

    07

    Clobazam

    Italy
    ASPEN
    Not Confirmed
    arrow

    08

    Clomiphene Citrate

    Italy
    ASPEN
    Not Confirmed
    arrow

    09

    Clonazepam

    Italy
    ASPEN
    Not Confirmed
    arrow

    10

    Clorazepate Dipotassium

    Italy
    ASPEN
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    Contact F.I.S. Fabbrica Italiana Sintetici and get a quotation

    F.I.S. Fabbrica Italiana Sintetici is a supplier offers 87 products (APIs, Excipients or Intermediates).

    Find a price of Chlordiazepoxide bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clonazepam bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clotrimazole bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Diazepam bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Furosemide bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Lorazepam bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Rifaximin bulk with DMF, CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Dorzolamide Hydrochloride bulk with CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Acetylcysteine bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Bromazepam bulk with CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Carbamazepine bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clomiphene Citrate bulk with DMF, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Diltiazem Hydrochloride bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Esomeprazole Magnesium bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Flurazepam bulk with DMF, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Fosfomycin Trometamol bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Gabapentin bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Imatinib Mesylate bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Indomethacin bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Midazolam bulk with CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nifedipine bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nitrazepam bulk with CEP, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nitrofurantoin bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Oxazepam bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Oxcarbazepine bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Pentazocine bulk with DMF, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Progesterone bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Quetiapine Hemifumarate bulk with DMF, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Sulindac bulk with DMF, JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Testosterone Propionate bulk with DMF, CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Entacapone bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Olopatadine Hydrochloride bulk with JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Oxcarbazepine bulk with CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Bazedoxifene bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Chlordiazepoxide bulk with CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Chlordiazepoxide HCl bulk with CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clobazam bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clomiphene Citrate bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Dorzolamide Hydrochloride bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Eletriptan Hydrobromide bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Erlotinib Hydrochloride bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Esomeprazole Magnesium bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Estazolam bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Flunitrazepam bulk with CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Flurazepam Monohydrochloride bulk with CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Fluvastatin Sodium bulk with JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Imatinib Mesylate bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Indomethacin Sodium bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Lansoprazole bulk with JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Midazolam Hydrochloride bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nebivolol bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nilotinib bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nitrofurantoin bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Olopatadine Hydrochloride bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Prasterone Acetate bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Propofol bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Safinamide Mesylate bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Sitagliptin Phosphate bulk with JDMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Temazepam bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Testosterone Cypionate bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Tramazoline Hydrochloride Monohydrate bulk with CEP offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of ENAMINE AMIDE (FIS0448) bulk with DMF offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of 2,5-Dibromo-1,4-Dimethyl-1H-Imidazole bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of 4-Des-Dimethylaminotetracycline bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Allopurinol bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Benzylhydrazine bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clobazam bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Clorazepate Dipotassium bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Desipramine Hydrochloride bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Diltiazem Hydrochloride bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Esomeprazole Magnesium bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Flunitrazepam bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Furazolidone bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Piroxicam bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Prazepam bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Quazepam bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Quetiapine Hemifumarate bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Solifenacin Succinate bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Terbinafine bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Tetrazepam bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Triamterene bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Trimethobenzamide HCl bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Trimethoprim bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of FIS0127 bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of CALCIUM CHANNEL BLOCKER - RO 40-5967/001 bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALTE DI MONTECCHIO MAGGIORE. bulk offered by F.I.S. Fabbrica Italiana Sintetici

    Find a price of Nelarabine bulk offered by F.I.S. Fabbrica Italiana Sintetici

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