Suppliers / Astrazeneca Pharmaceuticals Lp

Astrazeneca Pharmaceuticals Lp

United States Updated 9 July 2026

Astrazeneca Pharmaceuticals Lp is an API and finished-dose manufacturer based in United States. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with US FDA, MINSA (CR) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), US FDA and MHRA (UK), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 3 April 2026 as NAI.

3
active US DMFs
0
valid CEPs
12
registered plants 8 with an FDA FEI number
110
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
8 of 8 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 3 April 2026 NAI US FDA
  • 24 June 2025 NAI US FDA
  • 19 September 2023 VAI US FDA
  • 19 July 2023 NAI US FDA
  • 19 January 2023 VAI US FDA
  • 22 July 2022 VAI US FDA
  • 25 October 2021 NAI US FDA
  • 17 August 2018 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Mount Vernon, United Arab Emirates Not on file
Philadelphia, United Arab Emirates Not on file
Frederick, United Arab Emirates Not on file
NEWARK, United States Not on file
Frederick, United States 3002617771
Redwood City, United States 3011389428

6 further sites are on record.

What they file, and where

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 61 4
MINSA (CR) 23 None
ARCSA (EC) 9 None
INVIMA (CO) 8 None
NAFDAC (NG) 4 1
SFDA (Saudi Arabia) 3 None
ANVISA (Brazil) None 5
MHRA (UK) None 2
FDA (GH) None 1
NCELS (KZ) None 1

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Open risk flags

  • One recent serious compliance event is on record.
  • The most recent inspection outcome was NAI, on 3 April 2026.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates