PharmaZell draws upon a long history of successful custom synthesis projects, performed on a proprietary basis for pharmaceutical companies worldwide.

In addition to advanced intermediates (cGMP and non-cGMP), PharmaZell specializes in production of kilogram to multi-ton quantities of cGMP drug substances for all stages of clinical trials through commercialization.

With R&D and commercial production facilities in Raubling, Copenhagen, Chennai and soon in Vizag, PharmaZell offers innovators a high level of flexibility in asset utilization and cost structure.

PharmaZell brings a broad range of chemical and process technologies, as well as analytical method development capabilities, to synthetic route development, process development/optimization, validation batches and commercial scale production of active pharmaceutical ingredients (API).

In process development work we ensure that these processes are suitable for scale-up and are carried out in a regulatory compliant environment.

Drawing upon a wealth of regulatory experience in API filings with all relevant authorithies including the FDA, PharmaZell provides clients with effective documentary support of registration requirements, from the pre-IND (Investigational New Drug Application) stage through filing of Drug Master Files (DMF) for New Drug Applications (NDA).

PharmaZell sites and staff are well integrated and 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 deliverables

The intellectual property (IP) obtained from our customers at all stages is handled under full confidentiality.

Capabilities for Chemical Syntheses of Drug Substances and/or Advanced Intermediates

PharmaZell handles a broad range of chemical reactions and unit operations. Particular expertise exists 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)
PharmaZell brochure Custom Synthesis at PharmaZell