Lonza Biologics, Inc.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 101 International Drive, Portsmouth, New Hampshire (NH) 03801, United States (USA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3001451441 · DUNS 093149750
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-02-06
- NAIVaccines and Allergenic Products2024-03-07
- VAIHuman Cellular, Tissue, and Gene Therapies2024-03-07
- VAIDrug Quality Assurance2023-07-21
- NAIDrug Quality Assurance2017-09-21
- VAIDrug Quality Assurance2016-08-26
- VAIDrug Quality Assurance2015-02-10
- VAIDrug Quality Assurance2013-09-30
- VAIDrug Quality Assurance2010-04-21
- VAIDrug Quality Assurance2009-09-03
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- Efgartigimod Alfaargenx US
- efgartigimod alfa and hyaluronidase (human recombinant)argenx US
- obiltoxaximabElusys Therapeutics, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.