CordenPharma Drug Product Support Services

CordenPharma Drug Product Support Services
Product Description

SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS

  • Analytical Development
  • Validation Support
  • Regulatory Support
  • Clinical Supply Services

Corden Pharma International GmbH

  • DE
  • 2015
    On CPhI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Manufacturer/Innovator
Specifications
  • Supplied from
    Germany; Italy

Corden Pharma International GmbH

  • DE
  • 2015
    On CPhI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Manufacturer/Innovator

More Products from Corden Pharma International GmbH

  • CordenPharma Lipids & Carbohydrate Platform

    Product CordenPharma Lipids & Carbohydrate Platform

    Your Expert Partner for Standard & Proprietary Lipids & Carbohydrates
    • >> A specialized Lipids offering including custom and standard lipids (Glycero-Phospholipids, Sphingolipids, Phosphocholine, Pegylated, and Cationic Lipids).
    • >> Lipids for support of mRNA vaccine production including Phosphocholine, Pegylated, Cationic Lipids and highly pure plant-based CP BotaniChol® (cholesterol).
    • >> Fully-integrated service offering > from APIs to finished dosage and pharmaceutical services (clinical trial kits preparation, randomization and logistics).
    • >> Backward integration for key starting materials > securing the supply chain in terms of costs & quality.
    • >> Multiple manufacturing locations across Europe & the USA offering flexibility of supply.
  • CordenPharma Peptides Platform

    Product CordenPharma Peptides Platform

    Your Expert Partner for Peptide APIs
    • >> Proven track record delivering world class manufacturing services from early stage to commercial supply, including complex products (e.g., Linaclotide, Enfuvirtide, Mifamurtide, Eptifibatide, Glatiramer, GLP analogues).
    • >> Proprietary process technologies for cost-effective manufacturing and a robust CMC dossier by reduced chemical steps, increased purity, decreased raw material costs, and green approaches to reduce our carbon footprint.
    • >> A unique expertise in Peptides offering access to a wide range of products to meet customer needs.
    • >> Fully-integrated supply from peptide APIs to injectable Drug Products, with backward integration for key starting materials to secure supply chain.
    • >> Multiple manufacturing locations across Europe & the USA offering flexibility of supply while supporting our Business Contingency Plan (BCP).
  • CordenPharma Injectables Platform

    Product CordenPharma Injectables Platform

    Your Expert Partner for Clinical & Commercial Injectable Drug Product Supply
    • >> Wide & balanced range of injectable services incl. capability for combining injectable drugs and devices (combination products)
    • >> Aseptic and Terminal Sterilization Fill & Finish Technologies forPre-Filled Syringes (PFS), ampoules, liquid and lyophilized vials, supporting a wide range of filling volumes
    • >> Substantial Drug Product regulatory and filing experience globally (EMEA, FDA, PMDA)
    • >> Full-service CDMO offering, project management & integrated supply from APIs to final Drug Products>> Packaging / labeling
    • >> Clinical trial drug kit management (logistics, track & trace,documentation)
  • CordenPharma Highly Potent & Oncology Platform

    Product CordenPharma Highly Potent & Oncology Platform

    One Source for Highly Potent & Oncological Products
    • Integrated Supply: APIs & Oral / Sterile Drug Products
    • State-of-the-art facilities able to handle API and Drug Product of the highest potency
    • Development, clinical trial and commercial manufacturing
    • Full-service offering including packaging / labeling and distribution n facilities inspected by all major regulatory agencies


  • CordenPharma Small Molecules Platform

    Product CordenPharma Small Molecules Platform

    Full-Service Partner of Choice from Advanced Intermediates to Drug Products
    • Integrated network of cGMP facilities across Europe and US
    • 1,200 m3 of volumetric capacity in 20 L - 28,000 L reactors with various materials of construction
    • Clinical (Phase I-III) and ongoing commercial supply to multiple markets around the world (including US, Europe and Japan)
    • Kilo to Multi-ton production volumes per annum
    • Process development capabilities (including flow / continuous manufacturing)
    • All sites FDA and EMEA approved facilities with long history of successful regulatory and customer audits
    • Strong EHS programs in place at sites
  • CordenPharma Peptides APIs

    Product CordenPharma Peptides APIs


    CordenPharma is one of the leading manufacturers of peptide Active Pharmaceutical Ingredients (APIs) with an unprecedented track record of experience in supporting our customer along the value chain ranging from early clinical to commercial in worldwide markets. Today we support more than 50 cGMP development projects targeting either New Chemical Entities or Generic development activities. Furthermore our expertise covers ancillary areas such as conjugation to carbohydrates, lipids and pegylation. Most notably is the fact that scale does not represent any limitation at CordenPharma. We are the only company in the world who has sufficient capacity to produce peptide APIs from gram scale up to annual quantities of hundreds of kilograms. This is underlined by our experience in the manufacturing of Fuzeon® (enfuvirtide), with CordenPharma being the only company to have produced metric tons of this complex peptide.

  • CordenPharma Fully-Integrated Supply

    Product CordenPharma Fully-Integrated Supply

    CordenPharma’s vertically-integrated supply chain model provides development & manufacturing expertise spanning the complete GMP supply chain. Beginning with regulated Key Raw Materials and Non-GMP Intermediates, our sister organization WeylChem supports back integration to secure your supply chain. CordenPharma’s extensive infrastructure then expands the supply chain by providing GMP Starting Materials, manufacturing Active Pharmaceutical Ingredients (APIs) and commercial-scale Drug Products, including finished dosage formulation, and finally by supplying Pharma Packaging & Logistics > resulting in reduced development & manufacturing time and cost.
  • CordenPharma Sterile Liquid Drug Products

    Product CordenPharma Sterile Liquid Drug Products

    Sterile Drug Product manufacturing requires dedicated and specialized capabilities which are in compliance with FDA aseptic guidance and EMA regulatory requirements. CordenPharma has a long track record of experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampoules, vials and pre-filled syringes. Our facilities and equipment design, combined with experienced and trained personnel, are pivotal for success in sterile manufacturing. Currently, two sites of the CordenPharma network are involved in Sterile Liquid Drug Product manufacturing – CordenPharma Caponago and CordenPharma Latina.
  • CordenPharma Oral Formulation Tablets & Capsule Drug Products

    Product CordenPharma Oral Formulation Tablets & Capsule Drug Products

    CordenPharma’s service offerings include a wide range of products, formulations and services supporting new chemical entities, re-formulations and generics:
    • Powder & Granule-filled Capsules
    • Powder Granules & Pellets
    • Immediate Release Tablets
    • Controlled Release Tablets
    • Mini-tablets
    • Multi-layer Tablets
    • Blister & Bottle Packaging
  • CordenPharma Lipids & Carbohydrates APIs

    Product CordenPharma Lipids & Carbohydrates APIs

    LipidsCordenPharma’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 fully-scalable conversions leading to a wide range of phospholipid molecule derivatives.

    Carbohydrates
    CordenPharma is uniquely positioned to provide development and manufacturing services along the value chain ranging from clinical activities through process development, scale-up and GMP manufacturing of Complex Carbohydrates for a wide range of applications.


  • CordenPharma Derivatized Phospholipids - DPPC & More

    Product CordenPharma Derivatized Phospholipids - DPPC & More

    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 optimised and fully-scalable conversions leading to a wide range of phospholipids. 

    See https://www.cordenpharma.com/apis/lipids-complex-carbohydrates-api-manufacturing/derivatized-phospholipids for more info.
  • CordenPharma MPEG-Conjugated Lipids

    Product CordenPharma MPEG-Conjugated Lipids

    CordenPharma also pioneered the chemistry and large-scale manufacture of MPEG-conjugated phospholipids which can be accessed through a synthesis cascade, rendering them superior quality phospholipid examples for sensitive liposome formulation processes.
    • MPEG-2000-DMPE - CAS No 384835-59-0
    • MPEG-750-DSPE - CAS No 147867-65-0
    • MPEG-2000-DSPE - CAS No 147867-65-0
    • MPEG-5000-DSPE - CAS No 147867-65-0
    • MPEG-2000-DPPE  - CAS No 205494-72-0

Corden Pharma International GmbH resources

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