Fine Pharmaceuticals since 1927

 GEA Pharmaceutical A/S as a member of the PharmaZell group provides vertically integrated development programs covering pharmaceutical development, finished dosage forms, API development to API production, including regulatory documentation, procedures and strategies, all on one site.

GEA Pharmaceutical A/S was formed as a spin-off company from Novartis/Sandoz during 2007, consisting of the site, the API production, the pharmaceutical development, analytical, bioanalytical, clinical research, intellectual property and regulatory affairs departments of the former GEA, the core of a leading Scandinavian pharmaceutical company. In June 2007 Pharmazell acquired from Sandoz a controlling stake in GEA Pharmaceutical located in Copenhagen, Denmark. GEA’s broad capabilities in finished dosage form development and its experience in controlled substances complement now the portfolio of services and products that Pharmazell offers to its clients. After being a core pharmaceutical development center within the Hexal/Sandoz organization, GEA offers now its development skills and fully integrated services as a contract research organization to start-up, generic and originator companies:

• Drug Product Development
• Analytical Development
• Bioequivalence Studies
• API R&D Laboratory
• API Multipurpose Production
• Regulatory Affairs
• Intellectual Property
• Project Management
• QA/QC

GEA Pharmaceutical A/S provides high quality services at affordable prices to its clients. The business is determined to grow through continued investments in new and existing service areas. GEA Pharmaceutical A/S within the PharmaZell group offers to its clients standard and custom made APIs and intermediates from lab to large scale as well as all chemical, all kind of pharmaceutical development services, management of nonclinical and clinical development, nonclinical and clinical bioanalytics, and regulatory activities worldwide required to bring a pharmaceutical product to the market. PharmaZell develops innovative processes for APIs and Intermediates through its R&D groups that cover all scales from laboratory to commercial production.

GEA Pharmaceutical A/S serves its clients through the worldwide sales organization of PharmaZell, providing fast and competent solutions. GEA Pharmaceutical A/S and PharmaZell operate cGMP sites in Chennai/India, Copenhagen/ Denmark and Raubling/Germany with a total of about 330 employees. An additional site is currently being developed in Vizag/India. The combination of European and Indian sites generates flexibility in manufacturing capacities and attractive cost structures.

GEA Pharmaceutical A/S’s quality assurance and regulatory departments ensure full regulatory and GMP compliance. The group regularly passed FDA inspections during the last 20 years. All sites have been inspected by European authorities and GMP certificates are available for all APIs. GEA's quality assurance and regulatory departments ensure full regulatory compliant dossiers and cGMP compliant production of clinical trial batches.

 
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