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    Company profile for Axplora

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    Martin Meeson appointed as CEO of Axplora

    10 Apr 2024

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    Axplora plans €8m investment at French facility

    30 Jan 2024

    // PRESS RELEASE

    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

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    About

    Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

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    Headquarters, HochstraB-Süd 7, 83064 Raubling
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    INTERVIEW #SpeakPharma

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    "Axplora’s leading position in ADCs and how it is well-placed to serve the burgeoning GLP1 market"

    "Axplora’s leading position in ADCs and how it is well-placed to serve the burgeoning GLP1 market"

    This week, SpeakPharma interviews Martin Meeson, CEO of Axplora, a leading and reliable API manufacturing partner to some of the world’s biggest pharma and biotech companies. Meeson discusses Axplora’s expansion in the antibody-drug-conjugate (ADC) space and how it is well-placed to serve the exciting market for glucagon-like peptide 1 (GLP-1) drugs with its industrial footprint and purification technologies across several sites. 🔑 HIGHLIGHTS// API manufacturing partner to some of the world’s biggest pharma and biotech companies As a leader in the pharmaceutical industry, what inspired you to join Axplora? And, what do you consider the most rewarding aspect of your role as its CEO? When you look at Axplora as the custodian of strong brands like Farmabios, Pharmazell and Novasep you cannot help but be intrigued by what such breadth of offering and depth of technical expertise can achieve. Well, I was certainly intrigued! As a leader in the pharma space, the opportunity to guide an organization with several decades of experience is inspiring for me. For example, our site in Leverkusen was founded over 150 years ago by Alfred Nobel. With every meeting and site visit, I get increasingly impressed by the capabilities of the people that I meet. Now, it is my job to make sure that these capabilities are given the best opportunity to serve. In this sector, we have the privilege of working with our partners to supply and develop medicines that have such a positive impact on people’s lives. This for me is the most rewarding thing that we do. Sometimes the work that we do can seem a little far away from the patient. I always take time to remind myself, my staff, and hopefully also your readers of what we are doing and how our work impacts others. 🔑 HIGHLIGHTS// strong brands like Farmabios, Pharmazell and Novasep / positive impact on people’s lives How have recent industry developments influenced both API manufacturing and CDMO sectors, and what specific strategies has Axplora implemented to adapt to these changing market dynamics while maintaining its commitment to quality and innovation? As a CDMO, when you partner with us, there is always a focus on reliable supply, and we are still haunted by the challenges all of us faced during the pandemic. At Axplora, we have implemented numerous initiatives to increase the robustness of supply, particularly in looking at advances in sourcing and horizontal integration both within and across our network. At the same time, we have a strong focus on the impact that we are having on the planet and Axplora’s work in this area is tremendous — from increasing the amount and efficacy of waste management, notably the current programs around solvent recovery and recycling, to implementing more environment-friendly technologies such as electrochemistry. I am particularly excited by the cutting-edge work on moving to completely new processes that are water-based rather than solvent-based, creating a step change in impact for us and our partners. In addition, as a CDMO you have to constantly look at where your services fit within evolving markets. Axplora’s expansion in the ADC sector is an excellent example of tracking and investing in emerging technologies. Of note also is the current demand for GLP-1 medicines, and Axplora is well-placed to serve this exciting market with our industrial footprint in small molecules and purification technologies across several sites in our network. 🔑 HIGHLIGHTS// increase the robustness of supply / efficient waste management programs and environment-friendly technologies Can you discuss any recent advancement or breakthrough in API manufacturing or CDMO services at Axplora that have contributed to the company’s success? Our investment in ADC expansion is a key strength. Our Novasep business has some of the world’s leading capabilities in API manufacturing and purification. It is known worldwide for these capabilities. With increasing demand for GLP-1 drugs and the amazing impact they are having on patients globally, we are ready to support this growth across our extensive network. The race to oral dose medicines in this space is particularly exciting, and Axplora is looking forward to treating the vast patient population in diabetes and obesity. 🔑 HIGHLIGHTS// expansion in the ADC sector / treat the vast patient population in diabetes and obesity Looking ahead, what are some of the trends or developments you foresee in API manufacturing and CDMO services, and how is Axplora preparing to stay ahead of the curve in this ever-evolving pharmaceutical landscape? Whilst the landscape is evolving rapidly, regulations are not necessarily able to keep pace with the development of new molecules. The pandemic revealed that things can move more quickly. When I look at the challenging new regulation in adjacent spaces like cell therapy, I wonder how that pace can be applied to our sectors. To that end, you have to remain agile and responsive to customer needs. We have to ensure we invest to grow our capacity in the right areas. Our recent investments in Farmabios in Gropello Cairoli (Italy) to support our thriving steroids business and in Pharmazell in Vizag (India) to advance our specialty business are clear indications of how we can do this very successfully. It would be easier if I could point to just one thing that we are doing, but that is not how we win. The only way to stay ahead is by making a myriad of large and small adjustments and evolutions and that is where the Axplora group excels. Finally, one element I should mention is that we are part of a global supply chain. Therefore, our broad network stands ready to supply medicines to multiple geographies. Our investments reflect our worldwide customer base and ambitions. We are here to serve our partners and their patients. 🔑 HIGHLIGHTS// recent investments in Farmabios in Italy and Pharmazell in India / ready to supply medicines to multiple geographies

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    https://www.pharmacompass.com/speak-pharma/axplora-s-leading-position-in-adcs-and-how-it-is-well-placed-to-serve-the-burgeoning-glp1-market

    #SpeakPharma With Axplora
    23 May 2024
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    Corporate Presentation

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    CDMO Services for Pharmaceuticals 2024

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    CDMO Services for ADCs 2024

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    Finorga GMP Certificate 2024

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    Farmabios GMP Certificate 2024

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    PharmaZell GMP Certificate 2023

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    Novasep GMP Certificate 2022

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    Seripharm GMP Certificate 2021

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    Martin Meeson Appointed as CEO of Axplora

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    PharmaZell & Novasep Announce the Closing of their Merger.

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    In Negotiations with Novasep for Complex Small Molecules & ADCs

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-novo-s-parent-buys-catalent-for-us-16-5-bn-fujifilm-merck-kgaa-axplora-lonza-expand-capabilities

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    08 Aug 2024
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    NEWS #PharmaBuzz

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    Martin Meeson appointed as CEO of Axplora
    Martin Meeson appointed as CEO of Axplora

    10 Apr 2024

    // PRESS RELEASE

    https://www.axplora.com/martin-meeson-appointed-as-ceo-of-axplora/

    PRESS RELEASE
    10 Apr 2024
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    Axplora plans €8m investment at French facility
    Axplora plans €8m investment at French facility

    30 Jan 2024

    // PRESS RELEASE

    https://www.axplora.com/axplora-invests-e8-million-in-le-mans-to-further-expand-its-capacity-for-antibody-drug-conjugate-manufacturing/

    PRESS RELEASE
    30 Jan 2024
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    Axplora announces the appointment of its Scientific Advisory Board
    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

    // PRESS RELEASE

    https://www.axplora.com/scientific-advisory-board/

    PRESS RELEASE
    13 Nov 2023
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    Axplora announces the appointment of its Scientific Advisory Board
    Axplora announces the appointment of its Scientific Advisory Board

    13 Nov 2023

    // PRESS RELEASE

    https://www.axplora.com/scientific-advisory-board/

    PRESS RELEASE
    13 Nov 2023
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    Axplora's Ursodeoxycholic Receives 5-Year Renewed Registration
    Axplora's Ursodeoxycholic Receives 5-Year Renewed Registration

    07 Nov 2023

    // PRESS RELEASE

    https://www.axplora.com/axploras-ursodeoxycholic-receives-5-year-renewed-registration/

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    07 Nov 2023
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    Axplora appoints Dr. Stephan Haitz as President of its Novasep CDMO Business Unit
    Axplora appoints Dr. Stephan Haitz as President of its Novasep CDMO Business Unit

    18 Oct 2023

    // PRESS RELEASE

    https://www.axplora.com/axplora-appoints-dr-stephan-haitz-as-president-of-its-novasep-cdmo-business-unit/

    PRESS RELEASE
    18 Oct 2023
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    ALL APIs

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    01

    Mesalazine

    Germany

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-12-16

    Pay. Date : 2014-11-28

    DMF Number : 8070

    Submission : 1989-05-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2003-203 - Rev 03

    Issue Date : 2023-11-08

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10036

    Registrant's Address : ROSENHEIMER STR. 43 D-83064 RAUBLING, Germany

    Initial Date of Registration : 2007-02-13

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-03-18

    Valid Till : 2025-05-28

    Written Confirmation Number : WC-0019

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 12598-5151

    Start Marketing Date : 2001-04-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Takeda Pharmaceutical Company Korea Ltd.

    Registration Date : 2021-10-05

    Registration Number : 20210521-209-J-766(1)

    Manufacturer Name : PharmaZell (India) Private Ltd

    Manufacturer Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli – 531019 Andhra Pradesh, India

     VMF EU, CA, ... arrow-down
    ✖
    Available Reg. Filing : EU, CA, TW, BR, TH
    AUDIT
    Axplora CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Acetylcysteine

    Germany

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-07

    Pay. Date : 2013-04-03

    DMF Number : 5836

    Submission : 1985-03-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-028 - Rev 04

    Issue Date : 2020-12-15

    Type : Chemical

    Substance Number : 967

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10377

    Registrant's Address : ROSENHEIMER STR. 43, D-83064 RAUBLING, GERMARY

    Initial Date of Registration : 2007-12-19

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12598-7027

    Start Marketing Date : 1995-01-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF EU, CA, ... arrow-down
    ✖
    Available Reg. Filing : EU, CA, BR, CN
    AUDIT
    Axplora CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Betamethasone Valerate

    Germany

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-08-14

    Pay. Date : 2018-07-09

    DMF Number : 12749

    Submission : 1997-11-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-078 - Rev 03

    Issue Date : 2021-03-22

    Type : Chemical

    Substance Number : 811

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10098

    Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy

    Initial Date of Registration : 2022-07-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 46439-8711

    Start Marketing Date : 1989-05-31

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Axplora CB

    Product
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    Stock Recap
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    Place

    04

    Celecoxib

    Germany

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

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    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26356

    Submission : 2012-08-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-151 - Rev 02

    Issue Date : 2023-11-09

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-03-18

    Valid Till : 2025-05-28

    Written Confirmation Number : WC-0019

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2020-09-15

    Registration Number : 20200915-209-J-721

    Manufacturer Name : PharmaZell (India) Private Ltd

    Manufacturer Address : Plot No. 115, Ramky Pharma City (India) Ltd, SEZ, Parawada Mandal, Visakhapatnam District Andhra Pradesh India

     VMF EU, CA arrow-down
    ✖
    Available Reg. Filing : EU, CA
    AUDIT
    Axplora CB

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Fluocinolone Acetonide

    Germany

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

    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-05-16

    Pay. Date : 2013-05-07

    DMF Number : 17395

    Submission : 2004-05-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-103 - Rev 02

    Issue Date : 2023-02-16

    Type : Chemical

    Substance Number : 494

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10445

    Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy

    Initial Date of Registration : 2006-04-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 46439-8709

    Start Marketing Date : 1998-04-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF CN, SAU arrow-down
    ✖
    Available Reg. Filing : CN, SAU
    AUDIT
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    06

    Medroxyprogesterone Acetate

    Germany

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

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    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12695

    Submission : 1997-10-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-191 - Rev 03

    Issue Date : 2023-07-03

    Type : Chemical

    Substance Number : 673

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10098

    Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy

    Initial Date of Registration : 2010-03-17

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 46439-8712

    Start Marketing Date : 1992-02-05

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Saehan Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-58-B-142-01

    Manufacturer Name : Farmabios SpA

    Manufacturer Address : Farmabios SpA via Pavia 1 27027 GROPELLO CAIROLI-Pavia ITALY

     VMF Others AUDIT
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    07

    Methylene Blue

    Germany

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

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    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-12-26

    Pay. Date : 2023-09-26

    DMF Number : 32900

    Submission : 2023-09-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-129 - Rev 00

    Issue Date : 2024-09-27

    Type : Chemical

    Substance Number : 1132

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-03-18

    Valid Till : 2025-05-28

    Written Confirmation Number : WC-0019

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 12598-9541

    Start Marketing Date : 2018-01-08

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF EU arrow-down
    ✖
    Available Reg. Filing : EU
    AUDIT
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    08

    Propafenone Hydrochloride

    Germany

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-07

    Pay. Date : 2013-02-15

    DMF Number : 10641

    Submission : 1993-12-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-236 - Rev 03

    Issue Date : 2018-06-08

    Type : Chemical

    Substance Number : 2103

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-24

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0102

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 12598-6216

    Start Marketing Date : 1992-12-16

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Abbott Korea Ltd.

    Registration Date : 2022-01-24

    Registration Number : 20220124-209-J-1222

    Manufacturer Name : PharmaZell GmbH

    Manufacturer Address : Rosenheimer Straße 43 83064 Raubling Germany

     VMF EU, CA, ... arrow-down
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    Available Reg. Filing : EU, CA, BR, TH, ID
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    09

    Teriflunomide

    Germany

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-03

    Pay. Date : 2016-02-19

    DMF Number : 30220

    Submission : 2016-03-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-073 - Rev 00

    Issue Date : 2024-07-25

    Type : Chemical

    Substance Number : 3036

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-05-28

    Written Confirmation Number : WC-0019A3

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    10

    Triamcinolone Acetonide

    Germany

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-05-21

    Pay. Date : 2013-05-14

    DMF Number : 14693

    Submission : 2000-02-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-315 - Rev 00

    Issue Date : 2021-12-21

    Type : Chemical

    Substance Number : 533

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 305MF10085

    Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy

    Initial Date of Registration : 2023-07-19

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 46439-8703

    Start Marketing Date : 1999-02-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2019-12-09

    Registration Number : 20150130-65-B-382-10(1)

    Manufacturer Name : Farmabios SpA

    Manufacturer Address : Via Pavia 1-27027 Gropello Cairoli (PV), Italy

     VMF Others AUDIT
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    5-aminosalicylic Acid (mesalazine/me...

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-12-16

    Pay. Date : 2014-11-28

    DMF Number : 8070

    Submission : 1989-05-09

    Status : Active

    Type : II

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    02

    Balsalazide Disodium

    Germany
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-08-10

    Pay. Date : 2021-08-06

    DMF Number : 16425

    Submission : 2003-02-17

    Status : Active

    Type : II

    Axplora CB

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    03

    Beclometasone Dipropionate Monohydra...

    Germany
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21972

    Submission : 2008-09-11

    Status : Active

    Type : II

    Axplora CB

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    Beclomethasone Dipropionate

    Germany
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2019-04-25

    Pay. Date : 2019-04-22

    DMF Number : 12813

    Submission : 1998-01-05

    Status : Active

    Type : II

    Axplora CB

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    05

    Betamethasone Dipropionate Micronize...

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-07

    Pay. Date : 2013-09-26

    DMF Number : 23118

    Submission : 2009-09-16

    Status : Active

    Type : II

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    06

    Betamethasone Valerate

    Germany
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-08-14

    Pay. Date : 2018-07-09

    DMF Number : 12749

    Submission : 1997-11-18

    Status : Active

    Type : II

    Axplora CB

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    07

    Budesonide

    Germany
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-05-16

    Pay. Date : 2013-05-03

    DMF Number : 18910

    Submission : 2005-10-26

    Status : Active

    Type : II

    Axplora CB

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    08

    Budesonide Micronized Sterile

    Germany
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25615

    Submission : 2011-12-20

    Status : Active

    Type : II

    Axplora CB

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    09

    Busulfan

    Germany
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-08-08

    Pay. Date : 2012-12-17

    DMF Number : 25933

    Submission : 2012-03-27

    Status : Active

    Type : II

    Axplora CB

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    10

    Cannabidiol

    Germany
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34029

    Submission : 2019-07-24

    Status : Active

    Type : II

    Axplora CB

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    Acetylcysteine

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    Certificate Numbers : R2-CEP 1995-028 - Rev 04

    Status : Valid

    Issue Date : 2020-12-15

    Type : Chemical

    Substance Number : 967

    Axplora CB

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    02

    Beclometasone dipropionate, Micronised, ...

    Germany
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    Certificate Numbers : R1-CEP 2001-315 - Rev 02

    Status : Valid

    Issue Date : 2017-06-28

    Type : Chemical

    Substance Number : 654

    Axplora CB

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    03

    Betamethasone dipropionate, Micronised

    Germany
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    Certificate Numbers : R1-CEP 2003-232 - Rev 03

    Status : Valid

    Issue Date : 2023-02-08

    Type : Chemical

    Substance Number : 809

    Axplora CB

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    04

    Betamethasone valerate, Micronised

    Germany
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    Axplora

    Certificate Numbers : R1-CEP 2002-078 - Rev 03

    Status : Valid

    Issue Date : 2021-03-22

    Type : Chemical

    Substance Number : 811

    Axplora CB

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    05

    Budesonide, micronised

    Germany
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    Axplora

    Certificate Numbers : R1-CEP 2000-051 - Rev 02

    Status : Valid

    Issue Date : 2010-05-04

    Type : Chemical

    Substance Number : 1075

    Axplora CB

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    06

    Budesonide, Micronised, grades 21, 22 an...

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    Axplora

    Certificate Numbers : R1-CEP 2005-174 - Rev 01

    Status : Valid

    Issue Date : 2017-07-25

    Type : Chemical

    Substance Number : 1075

    Axplora CB

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    07

    Busulfan

    Germany
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    Axplora

    Certificate Numbers : R0-CEP 2018-265 - Rev 00

    Status : Valid

    Issue Date : 2020-03-24

    Type : Chemical

    Substance Number : 542

    Axplora CB

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    08

    Carbocisteine

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    Axplora

    Certificate Numbers : R1-CEP 1998-038 - Rev 05

    Status : Valid

    Issue Date : 2017-05-19

    Type : Chemical

    Substance Number : 885

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    09

    Celecoxib

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    Axplora

    Certificate Numbers : CEP 2012-151 - Rev 02

    Status : Valid

    Issue Date : 2023-11-09

    Type : Chemical

    Substance Number : 2591

    Axplora CB

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    10

    Chlormadinone acetate, Micronised (grade...

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    Certificate Numbers : CEP 2018-122 - Rev 03

    Status : Valid

    Issue Date : 2023-09-07

    Type : Chemical

    Substance Number : 2702

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    Virtual BoothAxplora- The partner of choice for complex APIs.

    16alpha-Hydroxyprednisolone

    Portfolio PDF

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    13951-70-7
    Budesonide
    Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing ...
    Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
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    16alpha-Hydroxyprednisolone

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    16alpha-Hydroxyprednisolone

    CAS Number : 13951-70-7

    End Use API : Budesonide

    About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world...

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    KEY PRODUCTS

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    Services

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    API Manufacturing

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    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

    KEY SERVICES

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    ABOUT THIS PAGE

    Contact Axplora and get a quotation

    Axplora is a supplier offers 113 products (APIs, Excipients or Intermediates).

    Find a price of Mesalazine bulk with DMF, CEP, JDMF, WC offered by Axplora

    Find a price of Acetylcysteine bulk with DMF, CEP, JDMF offered by Axplora

    Find a price of Betamethasone Valerate bulk with DMF, CEP, JDMF offered by Axplora

    Find a price of Carbocisteine bulk with CEP, JDMF, WC offered by Axplora

    Find a price of Celecoxib bulk with DMF, CEP, WC offered by Axplora

    Find a price of Clobetasol Propionate bulk with DMF, CEP, JDMF offered by Axplora

    Find a price of Fluocinolone Acetonide bulk with DMF, CEP, JDMF offered by Axplora

    Find a price of Medroxyprogesterone Acetate bulk with DMF, CEP, JDMF offered by Axplora

    Find a price of Methylene Blue bulk with DMF, CEP, WC offered by Axplora

    Find a price of Propafenone Hydrochloride bulk with DMF, CEP, WC offered by Axplora

    Find a price of Teriflunomide bulk with DMF, CEP, WC offered by Axplora

    Find a price of Triamcinolone Acetonide bulk with DMF, CEP, JDMF offered by Axplora

    Find a price of Balsalazide Disodium bulk with DMF, WC offered by Axplora

    Find a price of Beclomethasone Dipropionate bulk with DMF, CEP offered by Axplora

    Find a price of Betamethasone Dipropionate bulk with DMF, CEP offered by Axplora

    Find a price of Budesonide bulk with DMF, CEP offered by Axplora

    Find a price of Busulfan bulk with DMF, CEP offered by Axplora

    Find a price of Chlormadinone Acetate bulk with CEP, JDMF offered by Axplora

    Find a price of Cyproterone Acetate bulk with DMF, CEP offered by Axplora

    Find a price of Cystine bulk with CEP, WC offered by Axplora

    Find a price of Difluprednate bulk with DMF, JDMF offered by Axplora

    Find a price of Esmolol Hydrochloride bulk with DMF, WC offered by Axplora

    Find a price of Exemestane bulk with DMF, CEP offered by Axplora

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