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    Company profile for Sandoz B2B

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    xyz-pharma-m-2024-10-07

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    With Fermion, start the journey of your innovative API.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    About

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

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    Sandoz B2BSwitzerland Flag
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    Forum 1, Novartis Campus, CH-4056 Basel
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    +41 613241111
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 4566

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    Impressions: 365

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-bora-polpharma-make-acquisitions-evonik-euroapi-porton-announce-technological-expansions

    #PharmaFlow by PHARMACOMPASS
    19 Dec 2024
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    NEWS #PharmaBuzz

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    Sandoz Resolves US Generic Drug Antitrust Litigation
    Sandoz Resolves US Generic Drug Antitrust Litigation

    17 Dec 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/12/17/2997976/0/en/Sandoz-takes-further-steps-to-resolve-legacy-US-Generic-Drug-Antitrust-Class-Action-Litigation.html

    GLOBENEWSWIRE
    17 Dec 2024
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    FDA updates label of 33-year-old cancer drug with dose & warning
    FDA updates label of 33-year-old cancer drug with dose & warning

    21 Nov 2024

    // ENDPTS

    https://endpts.com/fda-updates-label-of-33-year-old-cancer-drug-with-new-dose-and-warning/

    ENDPTS
    21 Nov 2024
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    FDA Updates Label Of 33-Year-Old Cancer Drug With Warning
    FDA Updates Label Of 33-Year-Old Cancer Drug With Warning

    20 Nov 2024

    // ENDPTS

    https://endpts.com/fda-updates-label-of-33-year-old-cancer-drug-with-new-dose-and-warning/

    ENDPTS
    20 Nov 2024
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    Agomab Announces Appointment of Former Sandoz CFO
    Agomab Announces Appointment of Former Sandoz CFO

    18 Nov 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241118736621/en

    BUSINESSWIRE
    18 Nov 2024
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    EC grants approval to Sandoz’s biosimilar to treat retinal diseases
    EC grants approval to Sandoz’s biosimilar to treat retinal diseases

    16 Nov 2024

    // FINANCIALXPRESS

    https://www.financialexpress.com/business/healthcare-european-commission-grants-approval-to-sandozs-biosimilar-to-treat-retinal-diseases-3666104/

    FINANCIALXPRESS
    16 Nov 2024
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    Sandoz Receives EC Approval for Afqlir® Biosimilar
    Sandoz Receives EC Approval for Afqlir® Biosimilar

    15 Nov 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/11/15/2981760/0/en/Sandoz-receives-European-Commission-approval-for-Afqlir-aflibercept-further-strengthening-leading-biosimilar-portfolio.html

    GLOBENEWSWIRE
    15 Nov 2024
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    ALL APIs

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    01

    Amoxicillin Trihydrate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    Switzerland

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

    arrow
    Antibody Engineering
    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 : 2019-08-13

    Pay. Date : 2019-08-09

    DMF Number : 13764

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-034 - Rev 06

    Issue Date : 2015-11-12

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10115

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2024-08-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55984-0218

    Start Marketing Date : 2022-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2024-08-23

    Registration Number : 20240823-30-A-380-25

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria

     VMF Others AUDIT
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    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Amoxicillin Trihydrate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Amoxicillin Trihydrate

    Switzerland

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

    arrow
    Antibody Engineering
    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 : 2023-06-23

    Pay. Date : 2023-05-22

    DMF Number : 38086

    Submission : 2023-06-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-277 - Rev 00

    Issue Date : 2023-09-18

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10761

    Registrant's Address : Ctra. Granollers-Cardedeu C-251, Km 4, E-08520, Les Franqueses del Valles (Barcelona), Spain

    Initial Date of Registration : 2005-10-20

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55984-0218

    Start Marketing Date : 2022-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2024-08-23

    Registration Number : 20240823-30-A-380-25

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestrasse 10, 6250 Kundl, Tyrol, Austria

     VMF Others AUDIT
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    #PipelineProspector

    Market
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    03

    Ampicillin Sodium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Ampicillin Sodium

    Switzerland

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

    arrow
    Antibody Engineering
    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 : 2023-04-20

    Pay. Date : 2023-04-17

    DMF Number : 13754

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1993-005 - Rev 08

    Issue Date : 2024-02-20

    Type : Chemical

    Substance Number : 578

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10454

    Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

    Initial Date of Registration : 2005-08-24

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2021-11-05

    Registration Number : 20200603-210-J-404(1)

    Manufacturer Name : Sandoz GmbH@Sandoz Industrial Products S.A.

    Manufacturer Address : Biochemiestraβe 10 6250 Kundl Austria@Ctra. Granollers - Cardedeu C-251, km 4 08520 LES FRANQUESES DEL VALLES BARCELONA Spain

     VMF Others AUDIT
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    04

    Gentamicin Sulfate

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

    Antibody Engineering
    Not Confirmed
    arrow

    Gentamicin Sulfate

    Slovenia

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

    arrow
    Antibody Engineering
    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 : 13704

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-121 - Rev 02

    Issue Date : 2024-10-21

    Type : Chemical

    Substance Number : 331

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10041

    Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia

    Initial Date of Registration : 2008-02-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48866-8256

    Start Marketing Date : 2013-07-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    05

    Levothyroxine Sodium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Levothyroxine Sodium

    Switzerland

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

    arrow
    Antibody Engineering
    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 : 2013-01-15

    Pay. Date : 2012-12-21

    DMF Number : 4789

    Submission : 1983-01-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-141 - Rev 11

    Issue Date : 2023-09-26

    Type : Chemical

    Substance Number : 401

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10456

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2005-08-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 43858-410

    Start Marketing Date : 2010-02-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

    Product
    Web Link

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    Market
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    06

    Penicillin G Potassium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Penicillin G Potassium

    Switzerland

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

    arrow
    Antibody Engineering
    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 : 13767

    Submission : 1998-09-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-395 - Rev 03

    Issue Date : 2019-11-20

    Type : Chemical

    Substance Number : 113

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10072

    Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria

    Initial Date of Registration : 2019-03-12

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    Market
    Place

    07

    Cefpodoxime Proxetil

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

    Antibody Engineering
    Not Confirmed
    arrow

    Cefpodoxime Proxetil

    Switzerland

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16542

    Submission : 2003-04-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-283 - Rev 01

    Issue Date : 2017-12-05

    Type : Chemical

    Substance Number : 2341

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10129

    Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

    Initial Date of Registration : 2013-07-09

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : HKINNOEN Co., Ltd.

    Registration Date : 2014-07-25

    Registration Number : 20140611-25-A-300-07(1)

    Manufacturer Name : Sandoz GmbH

    Manufacturer Address : Biochemiestraβe 10, 6250 Kundl, Austria

     VMF Others AUDIT
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    08

    Penicillin G Potassium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Penicillin G Potassium

    Switzerland

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16847

    Submission : 2003-09-18

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1999-017 - Rev 05

    Issue Date : 2023-09-22

    Type : Chemical

    Substance Number : 115

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10169

    Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria

    Initial Date of Registration : 2017-08-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    Place

    09

    Rosuvastatin Calcium

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

    Antibody Engineering
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    Slovenia

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20765

    Submission : 2007-08-09

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2016-321 - Rev 01

    Issue Date : 2019-04-15

    Type : Chemical

    Substance Number : 2631

    Status : Withdrawn by Holder

     JDMF arrow-down
    ✖

    Registration Number : 228MF10155

    Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia

    Initial Date of Registration : 2016-08-08

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Korea Sandoz Co., Ltd.

    Registration Date : 2021-04-06

    Registration Number : 20210406-209-J-687

    Manufacturer Name : Lek Pharmaceuticals dd

    Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia

     VMF Others AUDIT
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    Market
    Place

    10

    Vancomycin Hydrochloride

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

    Antibody Engineering
    Not Confirmed
    arrow

    Vancomycin Hydrochloride

    Slovenia

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

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

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13223

    Submission : 1998-04-30

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-179 - Rev 03

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 1058

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF10740

    Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

    read-more
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    01

    3-desacetyl-7-aminocephalosporanic A...

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    02

    6-apa (6 Aminopenicillanic Acid)

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    6-methylergolene-8-carboxylic Acid

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    6-methylergoline-8b-carboxylic Acid

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    7-act

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    06

    7-amca

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    07

    7-amino-cephalosporanic Acid (7-aca)

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    7-paca (7-amino-3-propenyl-cephalosp...

    Switzerland
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    09

    Amlodipine Besylate

    Slovenia
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    10

    Amlodipine Besylate (process 2)

    Slovenia
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    LISTED APIs

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    Amoxicillin Sodium

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    01

    Amoxicillin Sodium

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Amoxicillin Sodium

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Amoxicillin Trihydrate

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    Amoxicillin Trihydrate

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Amoxicillin Trihydrate

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Ampicillin Sodium

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    Market
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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    03

    Ampicillin Sodium

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Ampicillin Sodium

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Ampicillin Trihydrate

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    04

    Ampicillin Trihydrate

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Ampicillin Trihydrate

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Clavulanic Acid

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    Market
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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    05

    Clavulanic Acid

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Clavulanic Acid

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Cloxacillin Sodium

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    Market
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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    06

    Cloxacillin Sodium

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Cloxacillin Sodium

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Co-amoxiclav

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    Co-amoxiclav

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Co-amoxiclav

    Switzerland
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    Antibody Engineering
    Not Confirmed
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    Sandoz B2B

    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.

    About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete o...

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    Flucloxacillin Sodium

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    08

    Flucloxacillin Sodium

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Flucloxacillin Sodium

    Switzerland
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    Sandoz B2B

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    Gentamycin Sulfate

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    Gentamycin Sulfate

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Gentamycin Sulfate

    Switzerland
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    Sandoz B2B

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    Levothyroxine Sodium

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    Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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    Levothyroxine Sodium

    Switzerland
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    Switzerland
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    European Commission Grants Approval to Sandoz’s Biosimilar to Treat Retinal Diseases

    Details:

    Afqlir (aflibercept-biosimilar) is a VEGF receptors inhibitor recombinant fusion protein. It is indication for the treatment of Neovascular (Wet) AMD.


    Lead Product(s): Aflibercept

    Therapeutic Area: Ophthalmology Brand Name: Afqlir

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 15, 2024

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    Sandoz B2B

    Switzerland
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    Switzerland
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    Lead Product(s) : Aflibercept

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    European Commission Grants Approval to Sandoz’s Biosimilar to Treat Retinal Diseases

    Details : Afqlir (aflibercept-biosimilar) is a VEGF receptors inhibitor recombinant fusion protein. It is indication for the treatment of Neovascular (Wet) AMD.

    Brand Name : Afqlir

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 15, 2024

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    Sandoz US Launches Generic Paclitaxel in Single-Dose Vial For Oncology Portfolio

    Details:

    Abraxane-Generic (paclitaxel) is a microtubule inhibitor indicated for metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer & metastatic pancreatic adenocarcinoma.


    Lead Product(s): Paclitaxel

    Therapeutic Area: Oncology Brand Name: Abraxane-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 11, 2024

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    Sandoz B2B

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    Lead Product(s) : Paclitaxel

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz US Launches Generic Paclitaxel in Single-Dose Vial For Oncology Portfolio

    Details : Abraxane-Generic (paclitaxel) is a microtubule inhibitor indicated for metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer & metastatic pancreatic adenocarcinoma.

    Brand Name : Abraxane-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 11, 2024

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    Sandoz Receives FDA Approval for Enzeevu™, Strengthening US Biosimilar Position

    Details:

    Enzeevu (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is approved by FDA for the treatment of Neovascular (Wet) AMD.


    Lead Product(s): Aflibercept

    Therapeutic Area: Ophthalmology Brand Name: Enzeevu

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 12, 2024

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    Sandoz B2B

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    Lead Product(s) : Aflibercept

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Receives FDA Approval for Enzeevu™, Strengthening US Biosimilar Position

    Details : Enzeevu (aflibercept), biosimilar of Eylea, is a recombinant fusion protein which inhibits VEGF A. It is approved by FDA for the treatment of Neovascular (Wet) AMD.

    Brand Name : Enzeevu

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 12, 2024

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    Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe for Inflammatory Diseases

    Details:

    Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Pyzchiva

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2024

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    04

    Sandoz B2B

    Switzerland
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe for Inflammatory Diseases

    Details : Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.

    Brand Name : Pyzchiva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 25, 2024

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    FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US

    Details:

    Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Pyzchiva

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Samsung Bioepis

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 01, 2024

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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Recipient : Samsung Bioepis

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US

    Details : Pyzchiva (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.

    Brand Name : Pyzchiva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 01, 2024

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    Sandoz Gets EU Approval for Wyost® and Jubbonti® Denosumab Biosimilars

    Details:

    Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.


    Lead Product(s): Denosumab

    Therapeutic Area: Oncology Brand Name: Wyost

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 22, 2024

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    06

    Sandoz B2B

    Switzerland
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    Switzerland
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    Lead Product(s) : Denosumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Gets EU Approval for Wyost® and Jubbonti® Denosumab Biosimilars

    Details : Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.

    Brand Name : Wyost

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    May 22, 2024

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    Lupin Launches Rymti Biosimilar Etanercept in Canada

    Details:

    Rymti is an etanercept-biosimilar TNF blocker indicated for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis.


    Lead Product(s): Etanercept

    Therapeutic Area: Immunology Brand Name: Rymti

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Lupin Ltd

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 03, 2024

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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Etanercept

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Recipient : Lupin Ltd

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Launches Rymti Biosimilar Etanercept in Canada

    Details : Rymti is an etanercept-biosimilar TNF blocker indicated for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis.

    Brand Name : Rymti

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    May 03, 2024

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    Samsung Bioepis Gains EC Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

    Details:

    Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: Pyzchiva

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Samsung Bioepis

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 22, 2024

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    08

    Sandoz B2B

    Switzerland
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    Sandoz B2B

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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Recipient : Samsung Bioepis

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Samsung Bioepis Gains EC Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

    Details : Pyzchiva (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.

    Brand Name : Pyzchiva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    April 22, 2024

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    Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

    Details:

    Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.


    Lead Product(s): Denosumab

    Therapeutic Area: Oncology Brand Name: Wyost

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 05, 2024

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    09

    Sandoz B2B

    Switzerland
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    Antibody Engineering
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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Denosumab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sandoz Receives FDA Approval for First and Only Denosumab Biosimilars

    Details : Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.

    Brand Name : Wyost

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    March 05, 2024

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    Sandoz Acquires Cimerli® Business from Coherus, Strengthening US Market Leadership

    Details:

    Through acquisition, Sandoz will access US biosimilar Cimerli (ranibizumab) from Coherus, used for treating Neovascular (Wet) Age-Related Macular Degeneration and Diabetic Macular Edema.


    Lead Product(s): Ranibizumab

    Therapeutic Area: Ophthalmology Brand Name: Cimerli

    Study Phase: ApprovedProduct Type: Large molecule

    Recipient: Coherus Biosciences

    Deal Size: $170.0 million Upfront Cash: $170.0 million

    Deal Type: Divestment March 04, 2024

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    Sandoz B2B

    Switzerland
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    Sandoz B2B

    Switzerland
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    Lead Product(s) : Ranibizumab

    Therapeutic Area : Ophthalmology

    Highest Development Status : Approved

    Recipient : Coherus Biosciences

    Deal Size : $170.0 million

    Deal Type : Divestment

    DEALS_DEV arrow-down

    Sandoz Acquires Cimerli® Business from Coherus, Strengthening US Market Leadership

    Details : Through acquisition, Sandoz will access US biosimilar Cimerli (ranibizumab) from Coherus, used for treating Neovascular (Wet) Age-Related Macular Degeneration and Diabetic Macular Edema.

    Brand Name : Cimerli

    Molecule Type : Large molecule

    Upfront Cash : $170.0 million

    March 04, 2024

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    FDA Orange Book

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    Europe

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    01

    Brand Name : Idarubicin

    Switzerland
    Antibody Engineering
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    Brand Name : Idarubicin

    Switzerland
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    Regulatory Info :

    Registration Country : Italy

    4-Demethoxydaunomycin

    Sandoz B2B

    Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...

    Dosage Strength : 1 vial EV 10 ml 1 mg/ml

    Packaging :

    Brand Name : Idarubicin

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Brand Name : Idarubicin

    Switzerland
    Antibody Engineering
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    Brand Name : Idarubicin

    Switzerland
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    Regulatory Info :

    Registration Country : Italy

    4-Demethoxydaunomycin

    Sandoz B2B

    Dosage Form : Idarubicin 5Mg 5Ml 1 Units Par...

    Dosage Strength : 1 vial EV 5 ml 1 mg/ml

    Packaging :

    Brand Name : Idarubicin

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    Brand Name : Abacavir Lamivudin S...

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Brand Name : Abacavir Lamivudin S...

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Abacavirum; Lamivudinum

    Sandoz B2B

    Dosage Form : Filmtabl

    Dosage Strength : 600/300mg

    Packaging :

    Brand Name : Abacavir Lamivudin Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
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    04

    Brand Name : Abirateron Sandoz

    Switzerland
    Antibody Engineering
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    Brand Name : Abirateron Sandoz

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Sandoz B2B

    Dosage Form : Filmtabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Abirateron Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    05

    Brand Name : Abirateron Sandoz

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Brand Name : Abirateron Sandoz

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Sandoz B2B

    Dosage Form : Filmtabl

    Dosage Strength : 1000mg

    Packaging :

    Brand Name : Abirateron Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
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    06

    Brand Name : Ecomucyl Sandoz

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Brand Name : Ecomucyl Sandoz

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylcystein

    Sandoz B2B

    Dosage Form : Gran

    Dosage Strength : 100mg

    Packaging :

    Brand Name : Ecomucyl Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Brand Name : Ecomucyl Sandoz

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Brand Name : Ecomucyl Sandoz

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylcystein

    Sandoz B2B

    Dosage Form : Gran

    Dosage Strength : 200mg

    Packaging :

    Brand Name : Ecomucyl Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Brand Name : Ecomucyl Sandoz

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Brand Name : Ecomucyl Sandoz

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylcystein

    Sandoz B2B

    Dosage Form : Gran

    Dosage Strength : 200mg

    Packaging :

    Brand Name : Ecomucyl Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    Brand Name : Ecomucyl Sandoz

    Switzerland
    Antibody Engineering
    Not Confirmed
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    Brand Name : Ecomucyl Sandoz

    Switzerland
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    Regulatory Info :

    Registration Country : Switzerland

    Acetylcystein

    Sandoz B2B

    Dosage Form : Effervescent Tablets

    Dosage Strength : 200mg

    Packaging :

    Brand Name : Ecomucyl Sandoz

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    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Switzerland

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    Sandoz B2B

    Dosage Form : Effervescent Tablets

    Dosage Strength : 600mg

    Packaging :

    Brand Name : Ecomucyl Sandoz

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Contact Sandoz B2B and get a quotation

    Sandoz B2B is a supplier offers 141 products (APIs, Excipients or Intermediates).

    Find a price of Amoxicillin Trihydrate bulk with DMF, CEP, JDMF offered by Sandoz B2B

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    Find a price of Levothyroxine Sodium bulk with DMF, CEP, JDMF offered by Sandoz B2B

    Find a price of Penicillin G Potassium bulk with DMF, CEP, JDMF offered by Sandoz B2B

    Find a price of Cefpodoxime Proxetil bulk with CEP, JDMF offered by Sandoz B2B

    Find a price of Penicillin G Potassium bulk with CEP, JDMF offered by Sandoz B2B

    Find a price of Amoxicillin Sodium bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Ampicillin bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Ampicillin Trihydrate bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Benzylpenicillin Sodium bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Cefazolin Sodium bulk with DMF, CEP offered by Sandoz B2B

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    Find a price of Ceftriaxone bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Clavulanic Acid bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Cloxacillin Sodium bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Penicillin G Benzathine bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Penicillin G Procaine bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Penicillin V Potassium bulk with DMF, CEP offered by Sandoz B2B

    Find a price of Cefixime bulk with DMF offered by Sandoz B2B

    Find a price of Cefixime bulk with CEP offered by Sandoz B2B

    Find a price of Cefotaxime bulk with DMF offered by Sandoz B2B

    Find a price of Cefpodoxime Proxetil bulk with DMF offered by Sandoz B2B

    Find a price of Clavulanic Acid bulk with DMF offered by Sandoz B2B

    Find a price of 1H-Imidazo 1 2-A Pyridin-4-Ium bulk with DMF offered by Sandoz B2B

    Find a price of 6-Aminopenicillanic Acid bulk with DMF offered by Sandoz B2B

    Find a price of 7-Amca bulk with DMF offered by Sandoz B2B

    Find a price of 7-Amino Cephalosporanic Acid bulk with DMF offered by Sandoz B2B

    Find a price of Amoxicillin Sodium bulk with CEP offered by Sandoz B2B

    Find a price of Azithromycin bulk offered by Sandoz B2B

    Find a price of CAS 24280-93-1 bulk with DMF offered by Sandoz B2B

    Find a price of Cefdinir bulk with DMF offered by Sandoz B2B

    Find a price of Cefepime bulk offered by Sandoz B2B

    Find a price of Cefozopran Hydrochloride bulk with JDMF offered by Sandoz B2B

    Find a price of Ceftazidime bulk with DMF offered by Sandoz B2B

    Find a price of Cefuroxime Axetil bulk offered by Sandoz B2B

    Find a price of Cephalosporin C Sodium bulk with DMF offered by Sandoz B2B

    Find a price of Clarithromycin bulk offered by Sandoz B2B

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    Find a price of Heparin Sodium bulk with DMF offered by Sandoz B2B

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    Find a price of PACA bulk with DMF offered by Sandoz B2B

    Find a price of Phenoxymethylpenicilline Benzathine Tetrahydrate bulk with CEP offered by Sandoz B2B

    Find a price of Piperacillin + Tazobactam bulk with DMF offered by Sandoz B2B

    Find a price of Piperacillin Sodium bulk with DMF offered by Sandoz B2B

    Find a price of Simvastatin bulk offered by Sandoz B2B

    Find a price of Sirolimus bulk with DMF offered by Sandoz B2B

    Find a price of Sodium Dicloxacillin bulk offered by Sandoz B2B

    Find a price of Temsirolimus bulk with DMF offered by Sandoz B2B

    Find a price of VICA CRUDE bulk with DMF offered by Sandoz B2B

    Find a price of VICA (PURE) bulk with DMF offered by Sandoz B2B

    Find a price of VICA, PURE (3-VINYL-ACA) bulk with DMF offered by Sandoz B2B

    Find a price of Amoxicillin Trihydrate bulk offered by Sandoz B2B

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    Find a price of Cefixime bulk offered by Sandoz B2B

    Find a price of Cefotaxime bulk offered by Sandoz B2B

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    Find a price of Chlorthalidone bulk offered by Sandoz B2B

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    Find a price of Cloxacillin Sodium bulk offered by Sandoz B2B

    Find a price of Clozapine bulk offered by Sandoz B2B

    Find a price of Cyclobenzaprine bulk offered by Sandoz B2B

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    Find a price of Deacetyl-7-Aminocephalosporanic Acid bulk offered by Sandoz B2B

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    Find a price of Esomeprazole Magnesium bulk offered by Sandoz B2B

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    Find a price of L-Arginine Hydrochloride API bulk offered by Sandoz B2B

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    Find a price of N-Butyl-6-Methylergoline-8-Carboxamide bulk offered by Sandoz B2B

    Find a price of Nafcillin bulk offered by Sandoz B2B

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    Find a price of NAFTIFINE HCL bulk offered by Sandoz B2B

    Find a price of Nitrofurantoin bulk offered by Sandoz B2B

    Find a price of Omeprazole Magnesium bulk offered by Sandoz B2B

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    Find a price of Oxytetracycline Hydrochloride bulk offered by Sandoz B2B

    Find a price of PACA bulk offered by Sandoz B2B

    Find a price of Pancrelipase bulk offered by Sandoz B2B

    Find a price of Pantoprazole Sodium bulk offered by Sandoz B2B

    Find a price of Penicillin G Benzathine bulk offered by Sandoz B2B

    Find a price of Pheniramine Maleate bulk offered by Sandoz B2B

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    Find a price of Pyrilamine Maleate bulk offered by Sandoz B2B

    Find a price of Rabeprazole bulk offered by Sandoz B2B

    Find a price of Recombinant Human Growth Hormone bulk offered by Sandoz B2B

    Find a price of Rosiglitazone Maleate bulk offered by Sandoz B2B

    Find a price of Roxithromycin bulk offered by Sandoz B2B

    Find a price of Rs-86 Hydrobromide bulk offered by Sandoz B2B

    Find a price of Sertraline Hydrochloride bulk offered by Sandoz B2B

    Find a price of Sodium Carbonate bulk offered by Sandoz B2B

    Find a price of Sulbactam Sodium bulk offered by Sandoz B2B

    Find a price of Sulfamethoxazole bulk offered by Sandoz B2B

    Find a price of Temazepam bulk offered by Sandoz B2B

    Find a price of Teniposide bulk offered by Sandoz B2B

    Find a price of Thiamylal bulk offered by Sandoz B2B

    Find a price of Thiethylperazine Maleate bulk offered by Sandoz B2B

    Find a price of Thiopental Sodium bulk offered by Sandoz B2B

    Find a price of Tiamulin Hydrogen Fumarate bulk offered by Sandoz B2B

    Find a price of Tizanidine HCl bulk offered by Sandoz B2B

    Find a price of Venlafaxine Hydrochloride bulk offered by Sandoz B2B

    Find a price of INVESTIGATIONAL DRUGS bulk offered by Sandoz B2B

    Find a price of TDM-85-530 b bulk offered by Sandoz B2B

    Find a price of SF86-327 (E)-N-(6,6-DIMETHYL-2-HEPTEN-4-YUL)-N--METHYL-1-NAPHTHALALENE bulk offered by Sandoz B2B

    Find a price of FACILITIES AND PROCEDURES IN WHITBY, ONTARIO, CANADA. bulk offered by Sandoz B2B

    Find a price of PHENYLALANINE-METHYLAMINOCYCLOL HCL bulk offered by Sandoz B2B

    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN BASLE, SWITZERLAND. bulk offered by Sandoz B2B

    Find a price of RS-86 CAPSULES IN 0.25 mg AND 1.0 mg (BASLE, SWITZERLAND PLANT) bulk offered by Sandoz B2B

    Find a price of ACEPAM bulk offered by Sandoz B2B

    Find a price of FACILITIES AND PROCEDURES IN NUREMBERG, GERMANY bulk offered by Sandoz B2B

    Find a price of SACA SODIUM SALT bulk offered by Sandoz B2B

    Find a price of LORAZETYL bulk offered by Sandoz B2B

    Find a price of RS-86 AMPULS 10 mg/ml AS PRODUCED IN THE BASLE, SWITZERLAND PLANT bulk offered by Sandoz B2B

    Find a price of CEFUROXIME bulk offered by Sandoz B2B

    Find a price of SDZ PSC 833 bulk offered by Sandoz B2B

    Find a price of Co-amoxiclav bulk offered by Sandoz B2B

    Find a price of Gentamicin Sulfate bulk offered by Sandoz B2B

    Find a price of Penicillin V bulk offered by Sandoz B2B

    Find a price of Penicillin V Benzathine bulk offered by Sandoz B2B

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