RESEARCH & DEVELOPMENT

API OPERATIONS

Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). The APIs operations are supported by the API Research and Development Centre located in Thessaloniki, Greece, and a second API Research and Development Centre in Vadodara, India. Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment. With these activities Pharmathen is able to control 50% of the product’s portfolio fully backwardly integrated.

Keeping the personnel at a high scientific level, whereas the vast majority holds a postgraduate diploma, the API research centers have brought high quality products to the company’s portfolio with novel and innovating cost-effective processes, compliances to the standards of International Guidelines and Pharmacopoeias, and  deliveries  based on the required internal timelines.

Both laboratories through the management system, structure and established partnerships with contract manufacturers offer:

  • Innovative , non-infringing, cost effective processes
  • IP support
  • Analytical method development and validation
  • Quality control of all stages of process (from raw material to final API)
  • Genotoxic evaluation and control of impurities
  • Control of cost in all stages of process (raw materials, intermediates, manufacturing cost)
  • Quality assurance based on cGMP requirements through all stages of development and production.
  • Regulatory support (DMF drafting, DMF filling, monitoring the procedures, updates etc).
  • Pilot and commercial quantities of APIs