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sterile apis gmp manufacturing cordenpharma

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.

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Sterile Segregated Antibiotic APIs CordenPharma

CordenPharma provides customers with dedicated technologies for the production of Sterile Segregated Antibiotic APIs through our experience with aseptic technique. Our sterile manufacturing facilities are comprised of: >> Chemical Processing & Sterile Filtration >> Crystallisation >> Isolation >> Drying & Powder Treatment >> Blending with

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Global API, Drug Product & Packaging CDMO CordenPharma

CordenPharma’s vertically-integrated supply chain model provides development & manufacturing expertise spanning the complete cGMP supply chain > from regulated raw materials through intermediates, APIs, commercial-scale Drug Product manufacturing, finished dosage formulation, packaging, clinical trial services, & pharma logistics > resulting in reduced development & manufacturing

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CordenPharma Expanding GMP Peptide Manufacturing in Colorado

Nov 25, 2020· The new expansion initiative will be augmented by our integrated supply of peptide APIs to Injectable Drug Products from CordenPharma Caponago, our facility in Italy dedicated to the Formulation Development and Drug Product manufacturing of sterile injectables. By leveraging our global facility network, this vertical supply model spans the

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CordenPharma Expands Non-GMP (SPPS) Peptide Manufacturing

Nov 17, 2020· Luxembourg, 17 November 2020. CordenPharma’s Centre of Excellence for Peptide Process Development and non-GMP manufacturing in Frankfurt, Germany is not only known for bringing a high level of peptide expertise in the development of efficient and lean peptide processes like Glucagon-Like Peptide analogues (GLP 1 or GLP 2), but also for being able to tackle challenging

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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 Small Molecule Intermediates & APIs Excipients Peptides Lipids Carbohydrates Conjugates Highly Potent API’s Oncology API’s Sterile API’s. Key

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CordenPharma invests in low to mid-kg peptide manufacturing

Nov 25, 2020· The expansion initiative will be augmented by an integrated supply of peptide APIs to injectable drug products from CordenPharma Caponago, the company’s facility in Italy dedicated to the formulation development and drug product manufacturing of sterile injectables.

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Manufacture of sterile active pharmaceutical ingredients

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 DMF, CEP, Written Confirmations, FDF, Prices

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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Seqens, CordenPharma, Baxter BioPharma, Avantor Announce

Nov 25, 2020· Earlier this month, CordenPharma announced plans to expand its solid-phase peptide synthesis manufacturing capacity at its Center of Excellence for Peptide Process Development and non-GMP manufacturing site in Frankfurt, Germany. The company provides an integrated supply of peptide active pharmaceutical ingredients

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CordenPharma invests in low to mid-kg peptide manufacturing

Nov 25, 2020· The expansion initiative will be augmented by an integrated supply of peptide APIs to injectable drug products from CordenPharma Caponago, the company’s facility in Italy dedicated to the formulation development and drug product manufacturing of sterile

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CordenPharma Acquires Pfizer API Manufacturing Facility in

CordenPharma, a leading Contract Development & Manufacturing Organization (CDMO), has entered into definite agreements to acquire the former Hospira Boulder (Colorado) high containment API site

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Guidance for Industry, Q7A Good Manufacturing Practice

Sep 24, 2001· I. INTRODUCTION (1) A. Objective (1.1) This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs

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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

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Q7 Good Manufacturing Practice Guidance for Active

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients . Guidance for Industry . Additional copies are available from: Office of Communications, Division of Drug Information

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CordenPharma announces peptide manufacturing capacity

Jul 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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Manufacturing Sterile Injectables Contract Pharma

Nov 01, 2015· Founder and chief executive officer of Symbiosis, Colin MacKay manages all aspects of the company’s day-to-day operations and drives strategic development. With over two decades of

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