Alkaloid AD Skopje
Farmaceutische, cosmetische en chemische producten vervaardigd en geëxporteerd vanuit Noord-Macedonië.
Alkaloid is het grootste farmaceutische bedrijf van Noord-Macedonië en produceert generieke medicijnen, vrij verkrijgbare gezondheidszorgproducten en cosmetica die naar meer dan 50 landen worden geëxporteerd. Het bedrijf beschikt over een EU-GMP-certificering en exploiteert meerdere gecertificeerde productielijnen voor vaste doseringsvormen, injectables en plaatselijke producten.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Skopje, North Macedonia
- Founded
- 1936
- Website
- alkaloid.com.mk
- Categories
- Medische en gezondheidszorgbenodigdheden, Persoonlijke verzorging
- Markets
- Servië, Kroatië, Bosnië en Herzegovina, Albanië, Duitsland
Listed in a source registry
Macedonian exporters directory
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-04 Mail server of the company domain
- debarment-clear (green), checked 2026-08-04 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-08-04 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- product-authorised-for-sale (green), checked 2026-08-21 Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
- certificate-page-on-site (amber), checked 2026-09-18 Company's own certification page
Claimed certifications, not confirmed by us
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
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)