Croma-Pharma GmbH
Austrian ophthalmic and aesthetic medicine manufacturer exporting hyaluronic acid products to 80+ countries.
Croma-Pharma develops and manufactures ophthalmic viscoelastic devices, dermal fillers, and aesthetic medicine products based on hyaluronic acid at its Lower Austria facility. The company distributes to more than 80 countries through direct affiliates and distribution partners, with a product range spanning surgical ophthalmology, aesthetics, and orthopedics.
- Type
- Manufacturer
- Location
- Leobendorf, Austria
- Founded
- 1976
- Website
- cromapharma.com
- Categories
- Medical & Healthcare Supplies, Personal Care
- Markets
- Germany, United Kingdom, Italy, France, Spain, United States, China, Australia, Brazil, Turkey
Verified facts
- domain-registered (green), checked 2026-08-08 Domain registry record
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- places-goods-on-market (green), checked 2026-08-07 Finnish Medicines Agency (Fimea), basic register of medicinal products
- facility-registered (green), checked 2026-08-16 European Industrial Emissions Portal (E-PRTR / IED), European Environment Agency
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- fda-registered (green), checked 2026-08-08 FDA
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- gmp-certified (green), checked 2025-06-25 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
Import rules for these goods
- Cosmetic products must be notified in the EU Cosmetic Products Notification Portal (CPNP) before being placed on the EU market. European Commission (CPNP)
- For the US market, MoCRA requires cosmetic facility registration and product listing with the FDA. US FDA (MoCRA)
- 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)