Sopharma AD
Sopharma AD manufactures generic medicines for export-ready B2B channels.
Sopharma AD manufactures generic medicines, OTC products, and pharmaceutical formulations in Sofia. Founded in 1933, the company supplies pharmacies, hospitals, medical wholesalers, and export distributors across BG, RO, GR, DE and related export markets.
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Founded
- 1933
- Website
- sopharma.bg
- Categories
- Medical & Healthcare Supplies
- Markets
- Bulgaria, Romania, Greece, Germany
Verified facts
- product-authorised-for-sale (green), checked 2026-08-21 Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
- gmp-certified (green), checked 2025-12-17 EudraGMDP, EU register of GMP certificates (EMA)
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
Claimed certifications
- Good Manufacturing Practice
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)