Opalia Pharma
Tunisian generics and OTC manufacturer serving domestic and Francophone African healthcare buyers.
Opalia Pharma is a Tunisian pharmaceutical manufacturer specializing in generics and over-the-counter products for human use, founded in 1988 by Alya El Hedda and Marco Montanari. The company exports to Algeria, Morocco, and several Francophone African markets.
- Type
- Manufacturer
- Location
- Tunis, Tunisia
- Founded
- 1988
- Website
- https://www.opaliapharma.com.tn
- Categories
- Medical & Healthcare Supplies
- Markets
- Tunisia, Algeria, Morocco, Cameroon
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- industrial-site-registered (green), checked 2026-08-19 APII (Agence de Promotion de l'Industrie et de l'Innovation, Tunisia), directory of operational industrial enterprises
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)