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  • Sterile Injectable Manufacturing Video CordenPharma

    CordenPharma Caponago (IT) is a GMP manufacturer of sterile liquid dosage with specialized expertise in Terminal Sterilization and Aseptic Fill Finish. Dr. Lee Newton Chief Operating Officer, CordenPharma. Dr. Lee Newton joins CordenPharma from Lonza, where he most recently held the role of Senior Vice President Business Unit Head for Lonza’s Small Molecule API business. Lee has

  • CDMO Expands US Peptide Manufacturing Capacity - CordenPharma Global API
  • Sterile Segregated Antibiotic APIs CordenPharma

    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 RD and manufacturing at DSM Fine Chemicals.

  • CDMO Expands US Peptide Manufacturing Capacity - CordenPharma Global API
  • CMO Expands US Peptide Manufacturing Capacity

    07/07/2020  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

  • API Development Manufacturing CordenPharma

    APIs manufactured to cGMP standards for commercial sale must meet stringent requirements for identity, strength, quality and purity. CordenPharma’s understanding of the development process, and access to resources throughout its network of facilities, allows for the fast and reliable supply of APIs. We provide seamless technology transfer ...

  • CordenPharma Sterile Injectable Manufacturing

    18/05/2020  Video > Sterile Injectable Drug Product Manufacturing Services. CordenPharma’s Injectable Drug Product facility, based near Milan in Caponago, Italy, is a cGMP manufacturer of sterile liquid dosage forms for injectable use, with specialized expertise in Terminal Sterilization, Sterile Emulsion, and Aseptic Fill Finish.. Organized under the Injectables Technology Platform, let us

  • CordenPharma

    CordenPharma’s Injectable Drug Product facility, based near Milan in Caponago, Italy, is a cGMP manufacturer of sterile liquid dosage forms for injectable use, with specialized expertise in Terminal Sterilization, Sterile Emulsion, and Aseptic Fill Finish. We offer you a broad spectrum of injectable services from RD GMP development, formulation and commercial-scale manufacturing, through ...

  • CordenPharma International GmbH APIs Active ...

    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.

  • Phospholipid Manufacturers I CordenPharma

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

  • Managing API Manufacturing with Asian ... - CordenPharma

    09/09/2019  CordenPharma and Weylchem are both owned by the International Chemical Investors Group (ICIG), which was founded in 2006 with the vision of building a privately-owned global industrial conglomerate covering non-GMP chemical production , and chemical pharmaceutical cGMP manufacturing services (among other businesses), the latter being formed into the CordenPharma

  • Corden Pharma - A Full-Service CDMO LinkedIn

    CordenPharma is your full-service partner in the Contract Development Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across ...

  • CordenPharma Switzerland Facility CordenPharma

    Sterile Injectable Formulation . Sterile Liquids ... is a cGMP manufacturing facility with expertise in the production of high quality chemical intermediates and active pharmaceutical ingredients including lipids, small molecules, GalNac and carbohydrates. Formerly a business unit of Genzyme Corporation, CordenPharma Switzerland brings extensive API manufacturing capability while adding ...

  • API GMP news

    API CordenPharma Increases US Peptide Manufacturing Capacity. GMPnewsNet-08.07.2020 0. 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

  • CordenPharma Acquires Pfizer API Manufacturing

    Located in proximity to the existing CordenPharma Colorado facility, Hospira Boulder produces Active Pharmaceutical Ingredients (APIs) and intermediate products with specialized capabilities in small to medium scale highly potent and cytotoxic API manufacturing. Previously owned by Pfizer / Hospira, the 54,000 square foot facility with more than 100 employees has API production capabilities ...

  • CordenPharma announces peptide manufacturing

    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 producer leading the ...

  • CordenPharma Acquires Pfizer API Manufacturing

    11/10/2017  “The acquisition will augment CordenPharma’s Highly Potent Oncology platform and integrated supply service offering in association with its drug product manufacturing expertise in the area of solid dosage and sterile injectables in CordenPharma Plankstadt [Germany] and CordenPharma Latina [Italy], respectively,” said Dr. Achim Riemann, managing director of ICIG, in a

  • Corden Pharma - A Full-Service CDMO LinkedIn

    CordenPharma is your full-service partner in the Contract Development Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across ...

  • Q 7 Good Manufacturing Practice for Active Pharmaceutical ...

    GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS TABLE OF CONTENTS Section Title 1 Introduction 1.1 Objective 1.2 Regulatory Applicability 1.3 Scope 2 Quality Management 2.1 Principles 2.2 Responsibilities of the Quality Unit(s) 2.3 Responsibility for Production Activities 2.4 Internal Audits (Self-Inspection) 2.5 Product Quality Review 3 Personnel 3.1 Personnel

  • DCAT Week '17 Announcement Forum: CordenPharma

    03/04/2017  Based on these commercial volume assumptions, CordenPharma has entered the oligonucleotide API manufacturing market by leveraging its existing capacity and expertise in developing and manufacturing large volumes of peptide APIs. The company currently works in the oligonucleotide field by developing and supplying synthetic lipids for oligonucleotide drug formulations by manufacturing

  • CordenPharma IC-Investors

    Marketing Sales provided by CordenPharma International for separately managed operating companies (legal and financial independence) 8 GMP production facilities in Europe and the United States ; € 390 million total sales; 1,530 employees; Key Technologies Drug Substance. Small Molecule Intermediates APIs Excipients Peptides Lipids Carbohydrates Conjugates Highly Potent API’s

  • Corden Pharma - A Full-Service CDMO LinkedIn

    Corden Pharma - A Full-Service CDMO 10,656 abonnés sur LinkedIn Experts Taking Care CordenPharma is your full-service partner in the Contract Development Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under five technology platforms – Peptides, Lipids amp;

  • Corden Pharma - A Full-Service CDMO LinkedIn

    CordenPharma is your full-service partner in the Contract Development Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across ...

  • CordenPharma to Manufacture Lipid Excipients for

    28/05/2020  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

  • Q 7 Good Manufacturing Practice for Active Pharmaceutical ...

    GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS TABLE OF CONTENTS Section Title 1 Introduction 1.1 Objective 1.2 Regulatory Applicability 1.3 Scope 2 Quality Management 2.1 Principles 2.2 Responsibilities of the Quality Unit(s) 2.3 Responsibility for Production Activities 2.4 Internal Audits (Self-Inspection) 2.5 Product Quality Review 3 Personnel 3.1 Personnel

  • DCAT Week '17 Announcement Forum: CordenPharma

    03/04/2017  Based on these commercial volume assumptions, CordenPharma has entered the oligonucleotide API manufacturing market by leveraging its existing capacity and expertise in developing and manufacturing large volumes of peptide APIs. The company currently works in the oligonucleotide field by developing and supplying synthetic lipids for oligonucleotide drug formulations by manufacturing

  • [PDF] - Continuous Manufacturing CordenPharma PDF

    19/05/2020  CordenPharma – Full-Service CDMO Linking Together a Legacy of Expertise Customised Service Packages organized under Technology Platforms spanning the entire Pharmaceutical Manufacturing Process Specialised Technologies for the Production of Oral, Sterile Highly Potent Pharmaceutical Drug Products and their APIs More than 40 years of Experience in European and

  • CordenPharma Moderna Extend Strategic

    28/05/2020  CordenPharma, the global pharmaceutical manufacturing platform of ICIG, is a full-service Contract Development Manufacturing Organization for APIs, Drug Products, and Packaging.

  • Good Manufacturing Practices: Aseptic and Sterile ...

    motortion - Stock.adobe Editor’s Note: This article was published in Pharmaceutical Technology Europe’s May 2020 print issue.. Taking the proper steps to comply with current good manufacturing practices (cGMPs) for aseptic and sterile processing in an efficient and effective manner is necessary for pharmaceutical manufacturing facilities and labs.

  • DCAT Week '17 Announcement Forum: CordenPharma

    03/04/2017  The oligonucleotide API manufacturing investment is taking place in CordenPharma Colorado (US), where the infrastructure already exists for small- to large-scale manufacturing. The investment consists of additional manufacturing suites and equipment capable of producing tens of grams to more than 10-kg batches of oligonucleotides. A team of oligonucleotide experts has been

  • CordenPharma erweitert Produktionskapazität für Peptid ...

    CordenPharma hat die Peptidherstellungskapazität in seiner GMP-API-Anlage in Boulder, Colorado, USA erweitert, um dem globalen Marktwachstum für Peptide gerecht zu werden. Der US-Standort des deutschen Unternehmens gilt als weltweit größtes Peptid-API-Produktionszentrum und ist bekannt für seine Herstellungsanlagen im Großmaßstab mit einem 10.000-L-SPPS (Solid-Phase Peptide

  • Corden Pharma - A Full-Service CDMO LinkedIn

    Corden Pharma - A Full-Service CDMO 10,656 abonnés sur LinkedIn Experts Taking Care CordenPharma is your full-service partner in the Contract Development Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under five technology platforms – Peptides, Lipids amp;

  • CordenPharma Moderna Extend Strategic

    28/05/2020  About CordenPharma CordenPharma, the global pharmaceutical manufacturing platform of ICIG, is a full-service Contract Development Manufacturing Organization for APIs,

  • [PDF] - Continuous Manufacturing CordenPharma PDF

    19/05/2020  CordenPharma – Full-Service CDMO Linking Together a Legacy of Expertise Customised Service Packages organized under Technology Platforms spanning the entire Pharmaceutical Manufacturing Process Specialised Technologies for the Production of Oral, Sterile Highly Potent Pharmaceutical Drug Products and their APIs More than 40 years of Experience in European and

  • CordenPharma Acquires Pfizer API Manufacturing Facility in ...

    produces Active Pharmaceutical Ingredients (APIs) and intermediate products with specialized capabilities in small to medium scale highly potent and cytotoxic API manufacturing. Previously owned by Pfizer / Hospira, the 54,000 square foot facility with more than 100 employees has API production capabilities ranging from very small scale up to 3,000 liters. Integrated into the CordenPharma ...

  • Good Manufacturing Practices: Aseptic and Sterile ...

    motortion - Stock.adobe Editor’s Note: This article was published in Pharmaceutical Technology Europe’s May 2020 print issue.. Taking the proper steps to comply with current good manufacturing practices (cGMPs) for aseptic and sterile processing in an efficient and effective manner is necessary for pharmaceutical manufacturing facilities and labs.

  • Tracking Expansions in High-Potency Manufacturing

    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. The facility, CordenPharma Boulder ...

  • Corden Pharma - A Full-Service CDMO LinkedIn

    Corden Pharma - A Full-Service CDMO 10,656 abonnés sur LinkedIn Experts Taking Care CordenPharma is your full-service partner in the Contract Development Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under five technology platforms – Peptides, Lipids amp;

  • Sterile, Non-sterile Manufacturing Operation Manuals ...

    The FDA, in its Guidance for Industry: Sterile Products Produced by Aseptic Processing – Current Good Manufacturing Practice requires that “ partially closed sterile product should be transferred only in critical areas. Facility design should ensure that the area between a filling line and the lyophilizer provide for Class 100 (ISO 5) protection. Transport and loading procedures should ...

  • International collaboration on GMP inspections European ...

    In December 2019, EMA and its European and international partners launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organise joint inspections of manufacturing sites of common interest. The products in scope include sterile medicines for human use of chemical origin and certain therapeutic ...

  • Formulation and Manufacturing Trends for Parenterals ...

    02/08/2019  Processing and manufacturing sterile parenteral dosage forms therefore requires a comprehensive approach, including a mastery of sterile containment, fill/finish and data-driven manufacturing and control processes. As this is a challenge that not all pharma companies can or are willing to address in-house, many are turning to strategic, full-service outsourcing partners to support

  • CDMO/CMO Expansions: Tracking Capacity Additions

    In 2016, Recipharm, a CDMO based in Jordbro, Sweden, invested more than EUR 1.2 million ($1.3 million) to enhance its small-scale GMP API development and manufacturing capabilities in its facility in Paderno Dugnano, Italy, by opening a new GMP kilo laboratory. As part of the investment, the facility’s existing chemical development laboratories were upgraded with the addition of technologies ...