Balkan Pharmaceuticals
Pharmaceutical manufacturer producing injectable and oral drug formulations for eastern European…
Pharmaceutical manufacturer producing injectable and oral drug formulations for eastern European and international wholesale markets.
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Founded
- 2006
- Website
- balkan-pharmaceuticals.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Bulgaria, Romania, Moldova, Ukraine
Verified facts
- domain-registered (green), checked 2026-08-12 Domain registry record
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
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)