Alkaloid AD Skopje
北マケドニアから製造および輸出される医薬品、化粧品、化学製品。
アルカロイドは北マケドニア最大の製薬会社で、ジェネリック医薬品、OTC ヘルスケア製品、化粧品を製造し、50 か国以上に輸出されています。同社は EU-GMP 認証を取得しており、固形剤形、注射剤、局所製品をカバーする複数の認証生産ラインを運営しています。
- 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
- 医療およびヘルスケア用品, パーソナルケア
- Markets
- セルビア, クロアチア, ボスニア・ヘルツェゴビナ, アルバニア, ドイツ
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)