Injectable Drug Product ManufacturingDeze pagina vertalen

    We offer you a broad spectrum of injectable services from R&D GMP development, formulation and commercial-scale manufacturing, through to clinical trial kit management, packaging & pharma-logistics. Cordenpharma's Aseptic Fill & Finish lines employ cutting-edge robot technology to adopt an open RABS set-up, as well as Nest & Tub RTF concepts to gain efficiency and assurance of quality.

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    [PDF] - Continuous Manufacturing .Deze pagina vertalen

    Continuous Manufacturing CordenPharma Experts taking care. CordenPharma Overview Your Full-Service CDMO Partner Full-Service CDMO Organized under 5 Technology Platforms € 365 Million Total Sales (2016) 11 Manufacturing Facilities in Europe / US (9 GMP Plants, 2 R&D Labs) 1,670 Employees . International Chemical Investors Group (ICIG) Market .

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    CordenPharma announces peptide manufacturing .Traduire cette page

    07/07/2020 · CordenPharma has announced a peptide manufacturing capacity expansion at its GMP API facility in Boulder, Colorado (US). Already known for its unique large-scale peptide offering with a 10,000 L SPPS (Solid-Phase Peptide Synthesis) vessel, and a 100 cm high-pressure reverse phase purification column, CordenPharma Colorado is recognised as the largest worldwide peptide API .

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    Lipids & Complex Carbohydrates API .Traduire cette page

    Lipids. CordenPharma's scientists have mastered the chemical total synthesis of complex derivatized phospholipids from multi-gram to multi-kilogram scale and are renowned for their contract lipid and phospholipid manufacturing expertise. Our large-scale proprietary cGMP manufacturing processes start with (S)-1,2-isopropylideneglycerol ((S)-IPG) and extend over a cascade of optimised and ...

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    API | GMP newsTraduire cette page

    CordenPharma is proud to announce peptide manufacturing capacity expansion in CordenPharma Colorado, their GMP API facility in Boulder, CO (US). Already known for its... Read more. API Cambrex Investing $3.6 Million at its Karlskoga, Sweden Facility . GMPnewsNet-01.07.2020 0. Cambrex, the leading small molecule company providing drug substance, announced that it is investing $3.6 million .

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    CordenPharma & Moderna Extend Strategic .Traduire cette page

    CordenPharma, the global pharmaceutical manufacturing platform of ICIG, is a full-service Contract Development & Manufacturing Organization for APIs, Drug Products, and Packaging.

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    Tides 2019 > Stand 403 | CordenPharmaDeze pagina vertalen

    CordenPharma exhibits at Tides 2019 - Stand 403, May 20-24 in San Diego, CA. Download presentations from the meeting or contact us for more information.

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    DCAT Week '17 Announcement Forum: .Deze pagina vertalen

    Corden Pharma is expanding into oligonucleotide active pharmaceutical ingredient (API) manufacturing, which is supported by a growing clinical pipeline of more than 150 oligonucleotide clinical projects, outlined Mimoun Ayoub, PhD, Director, Global Peptides, Oligonucleotides, Lipids, Carbohydrates & Injectables Platforms, CordenPharma, at the DCAT Member Company .

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    CordenPharma to Manufacture Lipid Excipients for .Traduire cette page

    CordenPharma, a contract development and manufacturing organization (CDMO) for APIs, drug products, and pharmaceutical packaging, extended their existing manufacturing agreement with Moderna to manufacture large-scale volumes of Moderna's lipid excipients to be used in the manufacture of Moderna's vaccine candidate (mRNA-1273) against the novel coronavirus (SARS .

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    [PDF] - Continuous Manufacturing .Deze pagina vertalen

    Continuous Manufacturing CordenPharma Experts taking care. CordenPharma Overview Your Full-Service CDMO Partner Full-Service CDMO Organized under 5 Technology Platforms € 365 Million Total Sales (2016) 11 Manufacturing Facilities in Europe / US (9 GMP Plants, 2 R&D Labs) 1,670 Employees . International Chemical Investors Group (ICIG) Market .

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    EU GMP Requirements · Fichier PDF

    Article 10: requirements for obtaining the manufacturing / import authorisation Directive 2003/94/EC (GMP basics) EC GMP-Guide (detailed guidance) Part I (Finished Products) + Annex 13 (IMPs) Part II Section 19 (APIs for Use in Clinical Trials) other Annexes as applicable (e.g. Annex 1 for Steriles, Annex 2 for Biologicals etc.)

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    CordenPharma International | APIs | Active ...Traduire cette page

    CordenPharma International, a full-service CDMO for a global market. Formed as the global pharmaceutical service & manufacturing platform of International Chemical Investors Group in 2006, CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services.

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    CordenPharma International | Pharmaceutical .Deze pagina vertalen

    CordenPharma International Sponsored Content - Mar 19, 2020 CordenPharma is your full-service CDMO partner for APIs, Drug Products, and Packaging Services.

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    API Development & Manufacturing | CordenPharmaDeze pagina vertalen

    Dr. Walter Kittl is the Interim Managing Director, CordenPharma Plankstadt, starting March 19, 2020. With over 35 years of experience in the pharmaceutical, CMO and fine chemical industries, Walter brings a holistic understanding of pharmaceutical manufacturing operations resulting from a multi-faceted career beginning as a Project Manager in R&D and manufacturing at DSM Fine Chemicals.

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    Tracking Expansions in High-Potency ManufacturingDeze pagina vertalen

    CordenPharma is a contract provider of both small-molecule APIs and drug products (including solid-dosage products and sterile injectables), acquired a former Pfizer facility, a 54,000-square-foot API manufacturing facility in Boulder, Colorado with more than 100 employees, in 2017, which included additional capabilities in high-potency manufacturing.

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    CordenPharma Adds Manufacturing Line for Vet .Deze pagina vertalen

    CordenPharma, a contract development and manufacturing organization (CDMO) for APIs, drug products, and packaging, will invest €10 million (almost $12 million) in a new manufacturing line dedicated to producing veterinary drug products for 500-kg scale batch sizes.

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    CordenPharma to Manufacture Lipid Excipients for .Deze pagina vertalen

    CordenPharma, a contract development and manufacturing organization (CDMO) for APIs, drug products, and pharmaceutical packaging, extended their existing manufacturing agreement with Moderna to manufacture large-scale volumes of Moderna's lipid excipients to be used in the manufacture of Moderna's vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2), the .

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    Manufacture of sterile active pharmaceutical ingredients · PDF-bestand

    Manufacture of sterile active pharmaceutical ingredients 6 4. Scope Most GMP guides for API's do not provide specific guidance on the manufacture of sterile API's. This CEFIC document provides this additional guidance which is unique to the manufacture and handling of sterile APIs. The manufacture of API intermediates used in sterile

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    CordenPharma Expands into Oligonucleotide APIs ...Deze pagina vertalen

    On July 1, 2016, CordenPharma announced that the company will expand into the oligonucleotide API development and manufacturing market. Corden has already begun to expand its Boulder, Colorado facility for the manufacture and development of oligonucleotide APIs. The expansion of the Colorado facility is expected to be complete by the end of 2016.

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    Q 7 Good Manufacturing Practice for Active Pharmaceutical ... · Fichier PDF

    (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. In this Guide "manufacturing" is defined to include all operations of receipt of materials, production, packaging, repackaging ...

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    CMO Expands US Peptide Manufacturing Capacity | .Deze pagina vertalen

    Luxembourg, 7 July 2020. CordenPharma is proud to announce peptide manufacturing capacity expansion in CordenPharma Colorado, their GMP API facility in Boulder, CO (US).Already known for its unique large-scale peptide offering with a 10'000 L SPPS (Solid-Phase Peptide Synthesis) vessel, and a 100 cm high-pressure reverse phase purification column, CordenPharma Colorado is recognized as .

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