CORDENPHARMA PLANKSTADT (DE)
- >> 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
- >> 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
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.
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 and hormones 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. In this smaller facility hormones can be manufactured at a batch size of 60-120 kg using secondary containment & PPE.
- >> 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