Alkaloid AD Skopje
Pharmaceutical, cosmetic, and chemical products manufactured and exported from North Macedonia.
Alkaloid is North Macedonia's largest pharmaceutical company, producing generic medicines, OTC healthcare products, and cosmetics that are exported to more than 50 countries. The company holds EU-GMP certification and operates multiple certified production lines covering solid dosage forms, injectables, and topical products.
- Type
- Manufacturer
- Location
- Skopje, North Macedonia
- Founded
- 1936
- Website
- alkaloid.com.mk
- Categories
- Medical & Healthcare Supplies, Personal Care
- Markets
- Serbia, Croatia, Bosnia & Herzegovina, Albania, Germany
Listed in a source registry
Macedonian exporters directory
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- 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
- 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)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
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)