One unit is dedicated to the production of penicillin-containing oral solid formulations.
ELPEN's operations housed at the Pikermi plant include:
- Pharmaceutical products production and quality control
- Distribution center of pharmaceutical and Para pharmaceutical products and medical devices
- Administrative services
- Research and Development Department
ELPEN's manufacturing units cover an area of 10,000 m2, while another 4,500 m2 is dedicated to storage. The remaining 1.500 m2 houses the Research and Development department.
Approximately 450 specialized employees work in pharmaceuticals production and quality control; 56 among them are scientific staff.
The areas where production and quality control take place are designed to comply with EU Good Manufacturing Practice (GMP) specifications. In those various pharmaceutical forms are produced, including:
- Solid oral dosage forms
- tablets (uncoated & coated)
- capsules
- dry suspensions (monodose, multidose)
- Solid oral dosage forms containing penicillin (Dedicated-use production unit)
- tablets (uncoated & coated)
- capsules
- dry suspensions (monodose, multidose)
- Liquid oral dosage forms
- oral solutions (monodose)
- oral solutions or suspensions (multidose)
- Inhalers
- dry powder inhalers
- Elpenhaler® device
- Lyophilized
- Liquids for injection
- small-volume (ampules, vials)
- large volume (soft bags)
- Nasal Sprays
Due to strict requirements pertaining to their manufacture, inhaled and penicillin-containing formulations are produced by limited manufacturers, and the ELPEN is one of them.
Standards of Operation
The overall operation of the site complies fully with the European standards related to the manufacture, storage and distribution of medicinal products (EU GMP, GSP, GDP). We are certified by several competent bodies, including the Greek National Organization for Medicines (Eudra GMP Compliance Certificate), the Food & Drug Administrations of Saudi Arabia and Jordan (SFDA GMP Compliance Certificate and JFDA GMP, as well as from the Authorities of Belarus, Kazakhstan, Iran & Iraq (Compliance Certificate, respectively). Our Quality Management System complies with the ISO 9001:2015 international standard.
Our warehouses are designed according to EU Good Manufacturing and Storage Practices. The unit has a surface of 4,500 sq.m. and a storage/management capacity of approx. 5,000 loaded pallets. The unit is fully air-conditioned, while storage conditions (relative humidity, temperature) are monitored and recorded in real time on a 24/7 basis.
Refrigeration units for products requiring special storage conditions are also available. Products are distributed by our fleet of five (5) privately owned, air-conditioned vehicles, and drivers who are permanent members of our trained staff.