Egis Pharmaceuticals PLC
Leading Hungarian generic pharmaceutical manufacturer exporting to over 100 countries.
Egis Pharmaceuticals is one of Central Europe's largest generic pharmaceutical producers, operating three manufacturing sites in Hungary certified by the EMA, FDA, ANVISA, PMDA and KFDA. The company's portfolio covers 653 products across 177 product lines and 158 active ingredients. Export revenue accounts for 72% of total sales, with strong presence across Eastern Europe, Russia, CIS countries and beyond.
- Type
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1913
- Website
- egis.health
- Categories
- Medical & Healthcare Supplies
- Markets
- Poland, Romania, Germany, Czechia
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- places-goods-on-market (green), checked 2026-08-07 Finnish Medicines Agency (Fimea), basic register of medicinal products
- gmp-certified (green), checked 2025-12-04 EudraGMDP, EU register of GMP certificates (EMA)
- domain-registered (green), checked 2026-08-08 Domain registry record
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 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)