Suppliers / Arevipharma

Arevipharma

Germany 69 employees Updated 9 July 2026

Arevipharma is an API manufacturer based in Germany. It holds 7 active US drug master files and 21 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by ZLG (DE) and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 June 2025 as VAI.

7
active US DMFs
21
valid CEPs
2
registered plants 1 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 20 June 2025 VAI US FDA
  • 16 September 2019 NAI US FDA
  • 29 April 2016 NAI US FDA
  • 16 November 2012 NAI US FDA
  • 8 April 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Radebeul, Germany Not on file
Germany, Germany 1000505976

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM, US FDA 7
Bisoprolol EDQM, SFDA (Saudi Arabia), US FDA 3
Esketamine EDQM, US FDA 2
Fentanyl EDQM 2
Ketamine EDQM, US FDA 2
Torasemide EDQM 2
Amiodarone EDQM 1
Carbamazepine EDQM 1
Cetirizine Dihydrochloride EDQM 1
Dimethyl Fumarate US FDA 1
Show all 17 molecules on file
Ebastine EDQM 1
Hydromorphone EDQM 1
Moxonidine EDQM 1
Pyridostigmine EDQM 1
Remifentanil EDQM 1
Sotalol EDQM 1
Tilidine EDQM 1

Also appears on these molecule pages

Amiodarone API Bisoprolol API Buprenorphine API Carbamazepine API Cetirizine API Dimethyl API Ebastine API Esketamine API Fentanyl API Hydromorphone API Ketamine API Pyridostigmine API
Show 3 more molecule pages
Remifentanil API Sotalol API Torasemide API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
ZLG (DE) None 4
US FDA None 1

Questions about Arevipharma

Does Arevipharma hold a US DMF or a CEP?
Arevipharma holds 7 active US drug master files and 21 valid CEPs. 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 Arevipharma FDA-registered?
One site operated by Arevipharma carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Arevipharma's last inspection go?
The most recent inspection on record closed on 20 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Arevipharma manufacture?
2 registered sites are on record, in Germany (Radebeul and Germany). Every site is listed on this page with the register it came from.
What does Arevipharma make?
17 molecules are on record against Arevipharma, including Buprenorphine, Bisoprolol, Esketamine and Fentanyl. Each links through to that molecule's full manufacturer list.
Which regulators recognise Arevipharma's GMP?
Current GMP certificates are on record from ZLG (DE) and US FDA. 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

  • The most recent inspection outcome was VAI, on 20 June 2025.

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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