Novartis Pharmaceutical Manufacturing GmbH

Langkampfen, AustriaFEI 3027031650API manufacture registered

Novartis Pharmaceutical Manufacturing GmbH is a drug establishment in Langkampfen, Austria, registered with the US FDA under FEI 3027031650. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 25 EU/UK GMP certificates are matched to this site, 20 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 manufactureLabellingDrug manufacturePackaging

GMP documents matched to this site (25)

DocumentAuthorityInspectionSource
484295-105633924
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-105619677
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-104295901
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-104642509
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-103675105
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-105471003
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-105600304
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-105582044
GMP certificate
Competent authority of Austria10 Oct 2025
within 3-year review window
EudraGMDP
484295-102485983
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-102504807
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-102771143
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-104299099
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-104090448
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-104466717
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-104484889
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-102362426
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-103507136
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-103890257
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-102525390
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484295-104659277
GMP certificate
Competent authority of Austria14 Dec 2023
within 3-year review window
EudraGMDP
484296-101956741
GMP certificate
Competent authority of AUSTRIA15 Feb 2023
outside 3-year review window
EudraGMDP
484295-101982076
GMP certificate
Competent authority of Austria14 Feb 2023
outside 3-year review window
EudraGMDP
484295-102029882
GMP certificate
Competent authority of Austria14 Feb 2023
outside 3-year review window
EudraGMDP
484295-102081921
GMP certificate
Competent authority of Austria14 Feb 2023
outside 3-year review window
EudraGMDP
484295-101533842
GMP certificate
Competent authority of Austria14 Feb 2023
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.

Other sites registered by the same company