CORDENPHARMA PLANKSTADT (DE) Home >> Facilities >> CordenPharma Plankstadt (DE) CORE CAPABILITIES >> Manufacturer of oral solid dosage forms >> Extensive primary & secondary packaging capacity >> Special expertise in formulating highly potent products >> Full range of services including formulation & process development, manufacturing of investigational medicinal products and pharma-logistics CAPACITIES READ FACT SHEET COMPLIANCE >> Inspected by German Authorities (Regierungspraesidium Tuebingen): Most Recently 2020 >> Registered in the EUDRAGMDP database according to EU Directive 62/2011 >> Relevant GMP Certificates (human drugs and veterinary drugs) are available on EUDRAGMDP database >> The QMS assures compliance to cGMP – as per EU GMP, Part I and ICH Q10 >> According to German law (AMG, AMWHV), batch release is performed by Qualified Persons >> Inspected by US-FDA since 2006 (FEI 3007014398) and accredited in Japan (AG21300103) >> Corden Pharma Plankstadt Inspections CORDENPHARMA 15 YEAR ANNIVERSARY CORPORATE GOVERNANCE >>SHE Policy (English) >>SHE Leitlinien (Deutsch) SHE CERTIFICATION >> Energy Management System according to ISO 50001:2018 (English) >> Energiemanagementsystem gemäß DIN EN ISO 50001:2018 (Deutsch) >> Fachbetrieb nach WHG (Deutsch) >> Environmental Management System according to ISO 14001:2015 (English) >> Umweltmanagementsystem gemäß ISO 14001:2015 (Deutsch) VIDEOS Glatt @ CordenPharma Plankstadt >> Watch Video View this 2018 video taken at CordenPharma Plankstadt highlighting Glatt's leading technology for highly potent laboratory scale containment pharma solutions. CordenPharma Plankstadt (DE) trusts in Glatt Technology. In technological partnership with Weiss Pharmatechnik, Glatt provides state-of-the-art pharma process solutions combined with top flexible barrier systems for highly potent containment developing services up to OEB 5 Level. CordenPharma Plankstadt Expanded Highly Potent Development Facility >> Watch Video On March 14, 2016, CordenPharma was pleased to announce the completion and approval of expanded Development Capabilities (CTD2) for mid-scale (up to 20 kg) contained capacity of highly potent and oncology oral dosage forms in CordenPharma Plankstadt (DE). This new and expanded capability provides customers a complete offering in the contained manufacturing of oral dosage from grams to 150 Kg. RELATED PRODUCTS & PLATFORMS APIs >> Highly Potent & Oncology Drug Products >> Oral Formulation Tablets & Capsules >> Veterinary Oral Formulation >> Drug Product Support Services >> Pharma Packaging & Logistics Technology Platforms Highly Potent & Oncology Small Molecules FACILITY LEGACY CordenPharma Plankstadt GmbH is an expert manufacturer of solid dosage forms with special expertise in formulation of highly potent products, offering a full range of services from pharmaceutical development for phase I-III and commercial scale manufacturing, to packaging and pharma-logistics (CEE-hub) for a global market. As a former operations site of AstraZeneca, CordenPharma Plankstadt has extensive expertise and capabilities in two facilities for the formulation of solid dosage products, for both non-potent and highly potent drug products, including cytotoxics with a clearly defined OEL/PDE value. Since its transition to CordenPharma in 2008, CordenPharma Plankstadt has also increased its development capabilities for highly potent drug products, growing its reputation as an expert in the QbD based development of oral solid dosage forms. CordenPharma Plankstadt has two plants available for the manufacturing of highly potent drug products. Highly potent drug products with a clearly defined OEL/PDE value can either be manufactured in a fully contained facility employing primary containment at a batch size of 100 – 150 kg or in a segregated area within the standard facility. HISTORY >> 1970 Rhein-Pharma (Imperial Chemical Industries / Rhein-Chemie) sets up a new production site at Plankstadt >> Start-up of packing facility >> 1978 Production is expanded by a new active substance purification facility >> Start-up of formulation facility >> 1983 Expansion of the laboratory capacities >> 2002 Start-up of the high-containment tablet production facility >> 2007 / 2008 former AstraZeneca Plankstadt plant acquired by ICIG to become Corden Pharma GmbH >> 2016 Extension of Formulation Development Area >> 2019 Further expansion of Formulation Development Area >> 2020 Start of Dedicated Veterinary Drug Product Manufacturing facility Keyboard shortcuts Map data ©2021 GeoBasis-DE/BKG (©2009) Terms of Use Report a map error View in Google Maps Geschäftsführer Dr. Lutz Henkel Corden Pharma GmbH Otto-Hahn-Strasse 68723 Plankstadt Germany VAT ID: DE271759255 Register court: Mannheim, HRB 709385 Phone: +49 6202 99 00 Fax: +49 6202 99 2000 Email Human Resources OPEN JOBS NEWS & PRESS EVENTS RESOURCE LIBRARY CAREERS ABOUT US CONTACT US TERMS AND CONDITIONS PRIVACY POLICY MEDIA CONTACT IMPRESSUM SITE MAP COVID-19 UPDATE Also of Interest: CORDEN PHARMA PLANKSTADT FACILITYCORDENPHARMA PLANKSTADT (DE)CORDEN PHARMA PLANKSTADT FACILITY CAPACITIES ©2021 CordenPharma International Website created by Advanta Advertising, LLC The CordenPharma Website is set to allow the use of cookies. Cookies help us to give you the best experience on our website. By clicking Accept or continuing to use the site, you agree to use our cookies. If you decline we will not track your information but your browsing experience might be limited. For more information on our Privacy Policy click here. ACCEPTDECLINE