Lonza Biologics, Inc.

Portsmouth, United StatesFEI 3001451441API manufacture registered

Lonza Biologics, Inc. is a drug establishment in Portsmouth, United States, registered with the US FDA under FEI 3001451441. Its registered operations are: Analytical testing, API manufacture. 2 EU/UK GMP certificates are matched to this site, 1 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.

Analytical testingAPI manufacture

GMP documents matched to this site (2)

DocumentAuthorityInspectionSource
CRN00GZJC
GMP certificate
Competent authority of Ireland6 Mar 2026
within 3-year review window
EudraGMDP
UK GMP 18601 Insp GMP 18601/11093-0002[H]
GMP certificate
MHRA14 Jun 2010
outside 3-year review window
MHRA-GMDP

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.

Other sites registered by the same company