HPAPI

We can handle Highly Potent API (HPAPI)

The HPAPI laboratory is equipped to safely manage High Potency Active Pharmaceutical Ingredients (HPAPI) with an Occupational Exposure Limit (OEL) no lower than 0.5 μg/m³ and an Occupational Exposure Band 5 (OEB5).

Highly Potent API

Highly Potent API Laboratory with EU-GMP Approved Analytical Laboratory

Experienced Developer

Experienced developer of value-added medicines ​with a proven track record in HPAPI manufacturing.

Highly Potent API Development

In 2023, a Highly Potent API laboratory was built in our facility in Athens to ensure operator and environmental safety, and to extend our in-house technical capabilities for new product development of highly potent substances. 

The steadily increasing demand for new products containing active substances categorized as highly potent, such as medicines to treat cancer, resulted in the strategic decision to allocate resources toward developing a dedicated suite in this fast-growing area of HPAPI manufacturing.

Approved and Certified

The dedicated suite for highly potent API products at our Athens facility has been certified as EU GMP compliant by the Greek Regulatory Authorities since 2023. It encompasses state-of-the-art laboratory technology and highly skilled professionals to meet your company’s needs in HPAPI manufacturing.

The Highly Potent API (HPAPI) laboratory features a lab-scale manufacturing area for the R&D production of both solid and liquid pharmaceutical products containing HPAPI, as well as an analytical laboratory. Adhering to GMP requirements, the laboratory is equipped to undertake the analysis of both liquid and solid pharmaceutical products and active substances, enhancing our capability in HPAPI manufacturing.

OEL and OEB5

OEBs are categories that classify chemicals based on their potential health risks and corresponding exposure limits. There are five categories in total—OEB1, OEB2, OEB3, OEB4, OEB5—with OEB1 representing the least toxic substances and OEB5 representing the most toxic.

Adragos facility in Athens is capable of handling high-potency compounds up to OEB 5, with an Occupational Exposure Limit (OEL) not lower than 0.5 μg/m³ (which is equal to 0.0005 mg/m³)