Research & Development
PharmaPath’s commitment to RnD is a key growth driver, firmly connected to our mission and out-licensing business strategy.
Our out-licensing portfolio primarily focuses on our in-house developed dossiers of oral solid dosage forms (immediate and extended-release tablets and capsules), allowing Day 1 generic entry for our partners upon patent expiry.
Our pharmaceutical development scientists have broad knowledge and expertise and are devoted to developing effective, patent non-infringing generic products of the highest quality.
Our fully integrated development activities range from pre-formulation to formulation and analytical development, scale-up, process validation, stability testing and execution. We adopt a QbD approach to our product development allowing the implementation of processes that achieve a consistent level of quality and efficiency further supporting our reliable supply.
We are constantly seeking reliable partners in the RnD field to add new products to our portfolio through technology transfer or co-development projects.
If you are interested in developing a partnership with us, please contact us at BD@pharmapath.eu
PharmaPath specializes in the out-licensing and the supply of high-quality generic pharmaceutical products to our customers in the European and the international generic marketplace.
Our portfolio contains solid dosage form products suitable for Day 1 launch upon patent expiry as well as flexible supply chains optimal for established generic products.
We offer fully integrated services covering all stages of the pharmaceutical value chain:
- Product Development
- Clinical design and execution
- RA support from regulatory approvals to product life cycle management
- Supply Chain Management
Your market needs and particular requirements are our main focus. We offer flexible solutions and excellent customer service to all our partners, from local players to multinational organizations, ensuring them a successful and strong market position.
If you are interested in building a solid B2B partnership with PharmaPath, please contact us at BD@pharmapath.eu.
Quality & Safety
The ultimate objective of PharmaPath is to assure the highest level of quality in its products and operations and offer to the market safe and effective medicines.
Our company implements a Quality Management System (QMS) that fully complies with EU GMP and international standards ISO 9001: 2015, ISO 14001:2015 and ISO 45001:2018.
PharmaPath’s Management ensures that the Quality Policy is designed, established and effectively deployed to all employees. We support our QMS with adequate resources, continuous employee training, suitable premises, equipment and facilities, constant procedures optimization, internal audits and periodic management reviews. We can proudly guarantee manufacture and quality control of medicinal products under strict Quality and Safety standards.
PharmaPath has a long history of successful inspections by the Greek National Agency, by Foreign Authorities (Russian Federation, Anvisa and Gulf Cooperation Council) as well as by an impressive number of partners.
PharmaPath’s site, located in Athens, Greece, is a 6400 m2 facility manufacturing solid dosage pharmaceutical products with continuous investment in state-of-the-art technology.
Our site at a glance
- Annual manufacturing capacity of over 2 billion units
- Wide range of technologies covering conventional and modified release oral solid forms
- High flexibility in product batch sizes through a range of manufacturing equipment sizes spanning from a few litters to 1200 litters.
- Fully installed Operational Excellence System
- Skilled and dedicated employees with high educational standards and extensive on-site service
- High Quality Standards and successful audits by
- National Greek Authority of Medicines EU GMP certificate
- Agência Nacional de Vigilância Sanitária (ANVISA – Brazil)
- Gulf Cooperation Council – GCC
- Russian Federation
- More than 150 audits from partners during the last ten years
- Environment Health and Safety standards
- Certified as per ISO 45001 : 2018
- Certified as per EN ISO 14001 : 2015
PharmaPath’s site produces generic products for over 75 different partners and is currently supplying more than 45 European and international markets through our out-licensing and contract manufacturing partners.
Our Quality Control Laboratory is fully equipped to support all physicochemical and microbiological tests required for the control and release of raw materials, packaging materials and finished products.
PharmaPath’s highly experienced QA team ensures that every production batch is manufactured, controlled and released under strict Quality and Safety standards and meets national requirements of different markets worldwide.