• from API Development to GMP Manufacturing
GEA Pharmaceutical and PharmaZell perpetrate a long tradition of successful
custom synthesis projects, performed for global pharmaceutical companies. GEA Pharmaceutical’s proprietary and
generic API background in the last decade has contributed decisively to Hexal’s and Sandoz’s commercial success.
In addition to advanced intermediates (cGMP and non-cGMP), we have specialized in the production of
kilogram to multi-ton quantities of cGMP drug substances for all stages of clinical trials
through to commercialization.
With R&D and commercial production facilities in Copenhagen, Raubling, Chennai and soon
Vizag, we offer to innovators a high level of flexibility in asset utilization and value optimization.
We bring a broad range of expertise in chemical and process technologies, as well as analytical
method development capabilities, synthetic route development, process development/optimization,
validation batches and commercial scale production of active pharmaceutical ingredients (API).
In our process development work we always ensure that the processes are suitable for scale-up and are
carried out in a compliance with all regulations.
Drawing upon a wealth of regulatory experience in API filings with the FDA, the EMEA and many other agencies,
GEA and PharmaZell provides clients with effective documentary support of registration
requirements, from the pre-IND (Investigational New Drug Application) stage through to filing of
Drug Master Files (DMF) for New Drug Applications (NDA).
The Group’s sites and staff are seamlessly organized for
• Rapid assessment and response to client inquiries
• Development of attractive project proposals
• Effective project management and
• Execution of projects against defined timelines and/or milestones
The intellectual property of our customers is handled with full confidentiality at all stages.
Capabilities for Chemical Syntheses of Drug Substances and/or Advanced Intermediates
We handle a broad range of chemical reactions and unit operations and offer particular expertise
in the fields of:
• Electrochemical reactions
• Diazotization
• Nitration (100% nitric acid)
• Hydrogenation
• Halogenation
• Epichlorohydrine chemistry
• Reactions with acid chlorides
• Amino acid chemistry
• Carbohydrate chemistry
• Pyrimidines
• Crystallization
• Milling and micronization
• Controlled substances
CUSTOM SYNTHESIS (Development and Manufacturing)
