HELSINN BIREX PHARMACEUTICALS LIMITED
HELSINN BIREX PHARMACEUTICALS LIMITED is a drug establishment in Dublin, Ireland, registered with the US FDA under FEI 3003724414. Its registered operations are: Analytical testing, Labelling, Drug manufacture, Packaging. 4 EU/UK GMP certificates are matched to this site, 3 inspected within the last three years.
Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology
Registered operations
Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.
GMP documents matched to this site (4)
| Document | Authority | Inspection | Source |
|---|---|---|---|
CRN00H3ZS-M00294/00001 GMP certificate | Competent authority of Ireland | 10 Jun 2026 within 3-year review window | EudraGMDP |
36542/IMP00058/00001 GMP certificate | Competent authority of Ireland | 10 Oct 2025 within 3-year review window | EudraGMDP |
36542-M00294/00001 GMP certificate | Competent authority of Ireland | 10 Oct 2025 within 3-year review window | EudraGMDP |
34512-M00294/00001 GMP certificate | Competent authority of Ireland | 15 Jul 2022 outside 3-year review window | EudraGMDP |
A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.
What this page does not show
- Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
- Capacity, scale, price or current availability: no regulator publishes these.
- FDA inspection classifications for this site, which are not yet linked.