PharmaZell - Drug Substance and Drug Product Development and Manufacturing

Drawing upon decades of experience in the development and commercial manufacture of oral solid dosage forms as well as APIs, amino acids and advanced intermediates, PharmaZell offers drug substance and drug product development and manufacturing services to pharmaceutical innovators and generic companies.

API and finished-dosage form projects

PharmaZell’s three R&D sites and four plant sites are located in Germany, Denmark and India. They offer a comprehensive package of assets, technologies, project management skills and regulatory services; all geared to provide rapid, cost-effective execution of API and finished-dosage form projects. With extensive experience with global regulatory agencies in DMF filing, PharmaZell provides innovators with support in preparation of CMC and IND packages as well as DMF filing.

Oral solid dosage forms and controlled substances

Within the PharmaZell Group our GMP-compliant site in Copenhagen, Denmark, has been used for integrated drug developments and API competence for more than 30 years, with a specific strength in oral solid dosage forms and controlled substances. Our site in Copenhagen has excessive experience of integrated contract drug development solutions. We can provide comprehensive services to support API supply and finished-dosage form development with drug application registrations.

API synthesis development and production, patents, and analytical and bio-analytical development and testing

The services offered at the site in Copenhagen include patent services, API synthesis development, pharmaceutical technologies' development, API production, analytical and bio-analytical development and testing, and regulatory affairs services and support. These services can be offered on a modular basis. The site in Copenhagen offers specific competency in handling problematic APIs and advanced formulations.

Strategic partnerships in drug product development and manufacture

Our philosophy is reflected through the high level of service, a culture of innovation, and flexibility. As a partner of pharmaceutical companies, we understand the core of our customers’ needs. We see the bigger picture and are aware of manufacturers’ typical challenges and obstacles in pharmaceutical processes. We believe in lasting strategic partnerships with a common purpose and common aims; these thrive best on the basis of proven technological competency, responsible action and mutual trust. The most enduring relationships are those whose elements blend together perfectly. This is our goal; this is what our growth strategy is geared towards.