Corden Pharma Plankstadt


Managing Director:

Johann Mueller


Corden Pharma GmbH

Otto-Hahn-Strasse
68723 Plankstadt
Germany 
Phone:+49 6202 99 2299
Fax:+49 6202 99 2000

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>>> Latest News - October 27, 2014 <<< CordenPharma Plankstadt announces today successful results from their latest FDA Inspection: No 483-observations
and no recommendations were reported.

 

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 and process development, manufacturing of investigational medicinal products and pharma-logistics
CordenPharma Plankstadt Facility Capacities

Compliance Approvals

  • FDA – 2014
  • German Authorities - 2014
  • ANVISA - 2009
  • EMEA - 2007

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 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 and PPE.

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 CordenPharma Plankstadt Gmbh