Sopharma
Bulgaria's leading pharmaceutical manufacturer since 1933
Sopharma Group is Bulgaria's leading pharmaceutical manufacturer and exporter, operating 9 EU-GMP certified production plants with over 200 medicinal products. Founded in 1933, it employs 5,600 people.
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Founded
- 1933
- Website
- sopharmagroup.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Bulgaria, Montenegro
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
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)