Lekhim
Oncology, immunology and generic pharmaceuticals
Lekhim manufactures oncology drugs, immunological preparations, and sterile injectables at its Kharkiv site. The company also produces medical devices such as disposable syringes and infusion sets. It has a contract manufacturing division serving international pharma clients.
- Type
- Manufacturer
- Location
- Kharkiv, Ukraine
- Founded
- 1992
- Website
- https://lekhim.ua
- Categories
- Medical & Healthcare Supplies
- Markets
- Ukraine, Poland, Kazakhstan, Azerbaijan, Uzbekistan, Moldova, Belarus, Georgia
Verified facts
- 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
Claimed certifications
- 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)