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
Frederick, United Arab Emirates Not on file
Philadelphia, United Arab Emirates Not on file
NEWARK, United States Not on file
Redwood City, United States 3011389428
Philadelphia, United States 3004829714

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Goserelin US FDA 2
Metoprolol US FDA 1
Sodium Zirconium Cyclosilicate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acalabrutinib finished dose Anastrozole finished dose Budesonide finished dose Dapagliflozin finished dose Dasatinib finished dose Entecavir finished dose Esomeprazole finished dose Exenatide finished dose Formoterol finished dose Fulvestrant finished dose Gefitinib finished dose Glycopyrronium finished dose
Show 8 more molecule pages
Metformin finished dose Metoprolol API Olaparib finished dose Quetiapine finished dose Roflumilast finished dose Rosuvastatin finished dose Saxagliptin finished dose Sodium Zirconium Cyclosilicate API

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

Questions about Astrazeneca Pharmaceuticals Lp

Does Astrazeneca Pharmaceuticals Lp hold a US DMF or a CEP?
Astrazeneca Pharmaceuticals Lp holds 3 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Astrazeneca Pharmaceuticals Lp FDA-registered?
8 sites operated by Astrazeneca Pharmaceuticals Lp carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Astrazeneca Pharmaceuticals Lp's last inspection go?
The most recent inspection on record closed on 3 April 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Astrazeneca Pharmaceuticals Lp manufacture?
12 registered sites are on record, in United Arab Emirates and United States (Mount Vernon, Frederick and Philadelphia among others). Every site is listed on this page with the register it came from.
What does Astrazeneca Pharmaceuticals Lp make?
3 molecules are on record against Astrazeneca Pharmaceuticals Lp, including Goserelin, Metoprolol and Sodium Zirconium Cyclosilicate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Astrazeneca Pharmaceuticals Lp's GMP?
Current GMP certificates are on record from ANVISA (Brazil), US FDA, MHRA (UK), FDA (GH), NCELS (KZ) and 1 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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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.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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