Novartis Pharmaceutical Manufacturing GmbH
- Type
- Manufacturer
- Location
- Langkampfen Tirol, Austria
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- product-authorised-for-sale (green), checked 2026-08-21 Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- fda-registered (green), checked 2026-08-15 FDA
- fda-contract-manufacturer (green), checked 2026-08-15 FDA
- debarment-clear (green), checked 2026-08-15 OpenSanctions
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- aeo-certified (green), checked 2026-08-16 EU AEO register (European Commission)
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- gmp-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
Claimed certifications
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
- AEO, Authorised Economic Operator EU AEO database
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)