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

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    FAMAR CDMO- From early development to commercial manufacturing.

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Veranova: A CDMO that manages complexity with confidence.

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    About

    We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formulations (Solid and Injectable). We export our products to MORE than 100 countries all over the world. Our production sites, most of them regularly inspected by EUROPEN AND USA AUTHORITIES (FDA), have strict Quality Standards and our R&D Know-how ma...
    We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formulations (Solid and Injectable). We export our products to MORE than 100 countries all over the world. Our production sites, most of them regularly inspected by EUROPEN AND USA AUTHORITIES (FDA), have strict Quality Standards and our R&D Know-how make us a leading company. Our Commitment: to work in the present while concentrating on the future, because on markets where research and technology are factors of primary importance.

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    ACS DOBFAR SPAItaly Flag
    Country
    Country
    Italy
    Address
    Address
    Viale Addetta 4/12 20067 Tribiano (Milan)
    Telephone
    Telephone
    +39-029-069-31
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    enquiries@pharmacompass.com
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    https://www.acsdobfar.it/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

    “We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

    This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules. 🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years? We have achieved incredible milestones over the last two years, thanks to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent CDMO by building on the 50 years of expertise that we brought with us. In addition, we expanded our capabilities and applied a more agile approach available to us as a company singularly focused on life sciences. This has allowed us to move into our second year with clear and strategic goals for generating growth in our sites, people, capabilities, and offerings. Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some exciting growth milestones of my own. Most recently, we announced an estimated US$ 30 million investment in our Devens, Massachusetts, site. This expansion will allow us to build upon existing development and manufacturing capabilities in ADCs and HPAPIs that will address the growing demand for strong US-based capacity in these key drug modalities. We also appointed our Advisory Board, thereby bolstering Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas. We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024. 🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years? The pharmaceutical pipeline is witnessing an increasing number of complex and highly potent molecules. This trend is driven by the demand for more targeted, patient-centric therapeutics and the focus on innovative modalities such as ADCs and other bioconjugates. At Veranova, our expertise, world-class facilities, and scientific excellence enable us to provide our customers with the clarity and solutions needed to manage this development and manufacturing complexity and ultimately deliver the required treatments to customers and patients. Our people are key to this approach. We have an expert team ready to collaborate with customers at any point, from early development through large-scale commercial production. Our services include world-leading crystallization development, process development, and specialized manufacturing expertise for complex synthetic molecules, including those requiring chromatography capabilities. In many cases, we can provide all these under one roof. Our service offering to our customers is also based on the foundational element of strong quality and compliance systems. We operate multiple facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually focused on ways to strengthen our global quality management system. Looking ahead, we are focused on continually investing in our facilities and team to meet growing complexity, as evidenced by our recent announcement of new investment in our Devens site. This investment signals our commitment to providing state-of-the-art capacity and capabilities to enable these next-generation therapies to reach patients. It is a key milestone as we advance Veranova’s broader growth strategy. 🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems How is Veranova approaching the challenge of designing and manufacturing effective linker molecules for ADCs? As a leader in complex linker-payload synthesis, Veranova is committed to unlocking the life-changing potential of ADCs without letting their complexities slow down the development of much-needed cancer therapies. ADCs are intricate, multi-component molecules that require extensive expertise and agile collaboration to overcome unique development challenges. With over a decade of experience in ADC linker-payload systems, we have developed the ability to anticipate challenges and avoid common pitfalls. The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic. We prioritize getting it right the first time, minimizing change orders and ensuring high-quality results. We have developed a robust phase-appropriate strategy that is backed by state-of-the-art analytical equipment and regulatory procedures to ensure our partners can rapidly progress their ADC projects from pre-clinical to commercialization. 🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects Can you specify how Veranova is using artificial intelligence (AI) to optimize manufacturing processes that can reduce costs and environmental footprint as well as speed up development? In May 2024, Veranova announced a partnership with Phorum.AI to leverage AI to optimize pharmaceutical manufacturing processes. This collaboration aims to enable the rapid development of processes that can drive efficiency and reduce costs while maximizing environmental sustainability. Our goal is to combine Veranova’s extensive empirical manufacturing dataset of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers. At Veranova, we are constantly looking to employ innovative technologies and approaches to improve efficiency, accelerate time to market and reduce environmental footprint. We have the means to work with a variety of partners who have unique project requirements, without sacrificing time to market.  🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint

    Impressions: 1891

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    https://www.pharmacompass.com/speak-pharma/we-re-unlocking-life-changing-potential-in-complex-molecules-without-sacrificing-time-to-market

    #SpeakPharma With Veranova
    10 Sep 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally.  Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go.  It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.
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    Impressions: 720

    https://www.pharmacompass.com/radio-compass-blog/bms-bayer-takeda-pfizer-downsize-to-combat-cost-pressures-meet-restructuring-plans

    #PharmaFlow by PHARMACOMPASS
    19 Sep 2024
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    NEWS #PharmaBuzz

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    Dobfar's Generic Cefepime Hydrochloride Receives Approval in the U.S.
    Dobfar's Generic Cefepime Hydrochloride Receives Approval in the U.S.

    03 Jan 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=065441

    FDA
    03 Jan 2022
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    ACS Dobfar SPA's Generic Penicillin G Potassium Receives Approval in US
    ACS Dobfar SPA's Generic Penicillin G Potassium Receives Approval in US

    31 Oct 2018

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205043

    FDA
    31 Oct 2018
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    Acs Dobfar Generic Ertapenem Sodium Receives Approval In US
    Acs Dobfar Generic Ertapenem Sodium Receives Approval In US

    19 Apr 2018

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208790

    FDA
    19 Apr 2018
    Share Share
    FDA Cites Three Pharma, Five Medical Device Companies
    FDA Cites Three Pharma, Five Medical Device Companies

    01 Feb 2017

    // PHARMA MANUFACTURING

    http://www.pharmamanufacturing.com/industrynews/2017/fda-cites-three-pharma-five-medical-device-companies/

    PHARMA MANUFACTURING
    01 Feb 2017
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    FACTA Farmaceutici Receives FDA Warning Letter
    FACTA Farmaceutici Receives FDA Warning Letter

    13 Jan 2017

    // FDA

    https://www.pharmacompass.com/pdf/news/facta-farmaceutici-receives-fda-warning-letter-1485923976.pdf

    FDA
    13 Jan 2017
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Ampicillin Sodium

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

    BioProcess International
    Not Confirmed
    arrow

    Ampicillin Sodium

    Italy

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

    arrow
    BioProcess International
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13661

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-303 - Rev 03

    Issue Date : 2024-01-24

    Type : Chemical

    Substance Number : 578

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10051

    Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy

    Initial Date of Registration : 2007-02-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0705

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : DRUG FOR FURTHER PRO...

    KDMF VMF Others AUDIT
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    Market
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    02

    Cefaclor

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

    BioProcess International
    Not Confirmed
    arrow

    Cefaclor

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13780

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-008 - Rev 04

    Issue Date : 2020-12-17

    Type : Chemical

    Substance Number : 986

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10591

    Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy

    Initial Date of Registration : 2006-06-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0912

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kyungbo Pharmaceutical Co., Ltd.

    Registration Date : 2020-05-11

    Registration Number : 20050831-20-A-17-02(20)

    Manufacturer Name : ACS DOBFAR SpA

    Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy

     VMF Others AUDIT
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    Market
    Place

    03

    Cefazolin Sodium

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

    BioProcess International
    Not Confirmed
    arrow

    Cefazolin Sodium

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13208

    Submission : 1998-04-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-083 - Rev 06

    Issue Date : 2019-06-17

    Type : Chemical

    Substance Number : 988

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10020

    Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy

    Initial Date of Registration : 2010-01-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0801

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2021-04-27

    Registration Number : 20210427-210-J-635

    Manufacturer Name : ACS Dobfar SpA

    Manufacturer Address : Viale Addetta, 2a/12-3/5 20067 Tribiano, Milano, Italy

     VMF Others AUDIT
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    04

    Ceftazidime

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

    BioProcess International
    Not Confirmed
    arrow

    Ceftazidime

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13683

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-299 - Rev 00

    Issue Date : 2024-07-29

    Type : Chemical

    Substance Number : 1405

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 305MF10039

    Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy

    Initial Date of Registration : 2023-03-23

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0924

    Start Marketing Date : 2019-05-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pfizer Pharmaceuticals Korea Co., Ltd.

    Registration Date : 2022-12-22

    Registration Number : 20221222-210-J-1424

    Manufacturer Name : ACS Dobfar SpA@ACS DOBFAR SpA

    Manufacturer Address : Viale Addetta, 2a/12–3/5, 20067 Tribiano (MI), Italy@Via Marzabotto, 1, 7/9 20871 Vimercate (MB), Italy

     VMF Others AUDIT
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    Market
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    05

    Amikacin Sulfate

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

    BioProcess International
    Not Confirmed
    arrow

    Amikacin Sulfate

    Italy

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

    arrow
    BioProcess International
    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 : 2013-12-05

    Pay. Date : 2013-07-05

    DMF Number : 13763

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 301MF10052

    Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy

    Initial Date of Registration : 2019-08-28

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0600

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Cefotaxime

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

    BioProcess International
    Not Confirmed
    arrow

    Cefotaxime

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14367

    Submission : 1999-08-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-050 - Rev 03

    Issue Date : 2008-02-28

    Type : Chemical

    Substance Number : 989

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0826

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Ceftriaxone

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

    BioProcess International
    Not Confirmed
    arrow

    Ceftriaxone

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17259

    Submission : 2004-03-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-393 - Rev 03

    Issue Date : 2024-04-26

    Type : Chemical

    Substance Number : 991

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0827

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Cefuroxime Sodium

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

    BioProcess International
    Not Confirmed
    arrow

    Cefuroxime Sodium

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13205

    Submission : 1998-04-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-007 - Rev 05

    Issue Date : 2022-07-25

    Type : Chemical

    Substance Number : 992

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52946-0905

    Start Marketing Date : 2009-12-09

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    09

    Cephalexin Monohydrate

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

    BioProcess International
    Not Confirmed
    arrow

    Cephalexin Monohydrate

    Italy

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13588

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1996-099 - Rev 04

    Issue Date : 2023-12-06

    Type : Chemical

    Substance Number : 708

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    10

    Cephalexin Monohydrate

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

    BioProcess International
    Not Confirmed
    arrow

    Cephalexin Monohydrate

    Italy

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

    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2017-02-27

    DMF Number : 13612

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1997-128 - Rev 03

    Issue Date : 2019-08-16

    Type : Chemical

    Substance Number : 708

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    17a-hydroxyprogesterone Caproate Usp...

    Italy
    BioProcess International
    Not Confirmed
    arrow

    02

    17a-hydroxyprogesterone, Bulk

    Italy
    BioProcess International
    Not Confirmed
    arrow

    03

    6-alpha-methylprednisolone-21-hydrog...

    Italy
    BioProcess International
    Not Confirmed
    arrow

    04

    6-amino Penicillanic Acid

    Italy
    BioProcess International
    Not Confirmed
    arrow

    05

    6-aminopenicillanic Acid (6-apa)

    Italy
    BioProcess International
    Not Confirmed
    arrow

    06

    7-adca (7-amino-3-desacetoxy Cephalo...

    Italy
    BioProcess International
    Not Confirmed
    arrow

    07

    7-amino-deacetoxy-cephalosporanic Ac...

    Italy
    BioProcess International
    Not Confirmed
    arrow

    08

    7-zaca- 7-amino-3-[2-(5-metbyl-1,3,4...

    Italy
    BioProcess International
    Not Confirmed
    arrow

    09

    Acid Cefazolin (intermediate Grade)

    Italy
    BioProcess International
    Not Confirmed
    arrow

    10

    Acid Cefotetan

    Italy
    BioProcess International
    Not Confirmed
    arrow
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    FDF Dossiers

    read-more
    read-more

    01

    Brand Name : ACETAMINOPHEN

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : ACETAMINOPHEN

    Italy
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    BioProcess International
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN

    ACS DOBFAR SPA

    Dosage Form : SOLUTION;INTRAVENOUS

    Brand Name : ACETAMINOPHEN

    Dosage Strength : 1GM/100ML (10MG/ML)

    Packaging :

    Approval Date : 2023-05-03

    Application Number : 215403

    Regulatory Info : RX

    Registration Country : USA

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    02

    Brand Name : AMPICILLIN SODIUM

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN SODIUM

    Italy
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : DISCN

    Registration Country : USA

    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 1GM BASE/VIAL

    Packaging :

    Approval Date : 2013-04-03

    Application Number : 90884

    Regulatory Info : DISCN

    Registration Country : USA

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    Market
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    03

    Brand Name : AMPICILLIN SODIUM

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN SODIUM

    Italy
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 10GM BASE/VIAL

    Packaging :

    Approval Date : 2013-04-03

    Application Number : 90889

    Regulatory Info : RX

    Registration Country : USA

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    04

    Brand Name : AMPICILLIN SODIUM

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN SODIUM

    Italy
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : DISCN

    Registration Country : USA

    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 500MG BASE/VIAL

    Packaging :

    Approval Date : 2013-04-03

    Application Number : 90884

    Regulatory Info : DISCN

    Registration Country : USA

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    05

    Brand Name : AMPICILLIN SODIUM

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN SODIUM

    Italy
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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : DISCN

    Registration Country : USA

    AMPICILLIN SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 2GM BASE/VIAL

    Packaging :

    Approval Date : 2013-04-03

    Application Number : 90884

    Regulatory Info : DISCN

    Registration Country : USA

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    Market
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    06

    Brand Name : AMPICILLIN AND SULBA...

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN AND SULBA...

    Italy
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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info : RX

    Registration Country : USA

    AMPICILLIN SODIUM; SULBACTAM SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 1GM BASE/VIAL;EQ 50...

    Packaging :

    Approval Date : 2009-12-22

    Application Number : 65406

    Regulatory Info : RX

    Registration Country : USA

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    Market
    Place

    07

    Brand Name : AMPICILLIN AND SULBA...

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN AND SULBA...

    Italy
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    AMPICILLIN SODIUM; SULBACTAM SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 10GM BASE/VIAL;EQ 5...

    Packaging :

    Approval Date : 2009-12-23

    Application Number : 65403

    Regulatory Info : RX

    Registration Country : USA

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    08

    Brand Name : AMPICILLIN AND SULBA...

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : AMPICILLIN AND SULBA...

    Italy
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : RX

    Registration Country : USA

    AMPICILLIN SODIUM; SULBACTAM SODIUM

    ACS DOBFAR SPA

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 2GM BASE/VIAL;EQ 1G...

    Packaging :

    Approval Date : 2009-12-22

    Application Number : 65406

    Regulatory Info : RX

    Registration Country : USA

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    Market
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    09

    Brand Name : N/A

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : N/A

    Italy
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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info :

    Registration Country : Italy

    Cefaclor

    ACS DOBFAR SPA

    Dosage Form : Capsules

    Brand Name :

    Dosage Strength : 500MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
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    10

    Brand Name : CEFACLOR

    Italy
    BioProcess International
    Not Confirmed
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    Brand Name : CEFACLOR

    Italy
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    BioProcess International
    Not Confirmed
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    Regulatory Info : DISCN

    Registration Country : USA

    CEFACLOR

    ACS DOBFAR SPA

    Dosage Form : FOR SUSPENSION;ORAL

    Brand Name : CEFACLOR

    Dosage Strength : EQ 250MG BASE/5ML

    Packaging :

    Approval Date : 1982-01-01

    Application Number : 62206

    Regulatory Info : DISCN

    Registration Country : USA

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    FDA Orange Book

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    Inspections and registrations

    Upload your audits for free, ask us

    GDUFA

    read-more
    read-more

    01

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    ACS DOBFAR SPA

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : ACS DOBFAR SpA - ADDETTA SITE

    Business Address : VIALE ADDETTA 2a/12 - 3/5 TR...

    FEI Number : 3002806297

    Country : Italy

    Paid in : 2019

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    02

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    ACS DOBFAR SPA

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : ACS DOBFAR SpA - ALBANO SITE

    Business Address : VIA TONALE 87 ALBANO SANT'AL...

    FEI Number : 3002806293

    Country : Italy

    Paid in : 2019

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    03

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
    arrow
    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    ACS DOBFAR SPA

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : ACS DOBFAR SpA - ROSSINI SITE

    Business Address : VIA ROSSINI 7/9/11 TRIBIANO ...

    FEI Number : 3002806298

    Country : Italy

    Paid in : 2019

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    04

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    ACS DOBFAR SPA

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : ACS DOBFAR SpA - VIMERCATE SIT...

    Business Address : VIA MARZABOTTO 1, 7/9 VIMERC...

    FEI Number : 3002806299

    Country : Italy

    Paid in : 2019

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    05

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    Antibioticos do Brasil Ltda

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Antibioticos do Brasil Ltda. (...

    Business Address : Rod Professor Zeferino Vaz, ...

    FEI Number : 3004132818

    Country : Brazil

    Paid in : 2019

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    06

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
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    BioProcess International
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Paid in : 2019

    ACS DOBFAR SPA

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : FACTA FARMACEUTICI SpA

    Business Address : ZONA INDUSTRIALE SANT'ATTO S...

    FEI Number : 3006028606

    Country : Italy

    Paid in : 2019

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    07

    GDUFA fees paid

    USA
    BioProcess International
    Not Confirmed
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    GDUFA fees paid

    USA
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    BioProcess International
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Paid in : 2019

    ACS DOBFAR SPA

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : InfoRLife SA

    Business Address : Casai Campascio GR 7748 Swit...

    FEI Number : 3004537783

    Country : Italy

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact ACS DOBFAR SPA and get a quotation

    ACS DOBFAR SPA is a supplier offers 133 products (APIs, Excipients or Intermediates).

    Find a price of Ampicillin Sodium bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find a price of Cefaclor bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find a price of Cefazolin Sodium bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find a price of Ceftazidime bulk with DMF, CEP, JDMF offered by ACS DOBFAR SPA

    Find a price of Amikacin Sulfate bulk with DMF, JDMF offered by ACS DOBFAR SPA

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    Find a price of Cefepime bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Cefotaxime bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Ceftriaxone bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Cefuroxime Sodium bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Cephalexin Monohydrate bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Cilastatin Sodium bulk with DMF, JDMF offered by ACS DOBFAR SPA

    Find a price of Clindamycin Phosphate bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Meropenem bulk with DMF, CEP offered by ACS DOBFAR SPA

    Find a price of Sulbactam Sodium bulk with DMF, JDMF offered by ACS DOBFAR SPA

    Find a price of Clindamycin Hydrochloride bulk with CEP offered by ACS DOBFAR SPA

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