BiotechPole Sidi Thabet
Tunisian biotechnology and pharmaceutical manufacturer at Sidi Thabet science park.
BiotechPole Sidi Thabet is a pharmaceutical and biotechnology manufacturing company operating within Tunisia's Sidi Thabet biotech park, producing biosimilars and specialty pharmaceutical products for domestic and African export markets. The company collaborates with the Institut Pasteur de Tunis on research and development.
- Type
- Manufacturer
- Location
- Sidi Thabet, Tunisia
- Founded
- 2003
- Website
- https://www.biotechpole.tn
- Categories
- Medical & Healthcare Supplies
- Markets
- Tunisia, Algeria, Morocco, Senegal
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
Claimed certifications
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)