alcami
Alcami
Deep Experience. Shared Purpose. Advancing pharmaceuticals and biologics from development to delivery. Drug Product Manufacturing Comprehensive Sterile Fill-Finish and Oral Solid Dose drug product manufacturing and support services, spanning from preclinical through commercial supply.
- Type
- Manufacturer
- Location
- Durham, United States
- Website
- https://www.alcaminow.com
- Categories
- Pharmaceutical Manufacturing, Packaging & Printing Supplies, Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-04 Mail server of the company domain
- debarment-clear (green), checked 2026-08-04 OpenSanctions
- sanctions-clear (green), checked 2026-08-04 OpenSanctions
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
- industrial-permit (green), checked 2026-08-23 ECHO, Enforcement and Compliance History Online (U.S. Environmental Protection Agency)
- domain-registered (green), checked 2026-08-04 Domain registry record
- facility-registered (green), checked 2026-08-03 US EPA Facility Registry Service
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)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)