Suppliers / Chr. Olesen Synthesis A/S

Chr. Olesen Synthesis A/S

Denmark 67 employees Updated 9 July 2026

Chr. Olesen Synthesis A/S is an API manufacturer based in Denmark. It holds 2 active US drug master files and 7 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 22 November 2023 as VAI.

2
active US DMFs
7
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 22 November 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Hvidovre, Denmark Not on file
Denmark, Denmark 3006358320

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM, US FDA 3
Dexamfetamine Sulfate EDQM 1
Hydromorphone EDQM 1
Pramipexole US FDA 1
Pramipexole Dihydrochloride EDQM 1
Terbinafine EDQM 1
Tolfenamic Acid EDQM 1

Also appears on these molecule pages

Buprenorphine API Hydromorphone API Pramipexole API Terbinafine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Chr. Olesen Synthesis A/S

Does Chr. Olesen Synthesis A/S hold a US DMF or a CEP?
Chr. Olesen Synthesis A/S holds 2 active US drug master files and 7 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 Chr. Olesen Synthesis A/S FDA-registered?
One site operated by Chr. Olesen Synthesis A/S 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 Chr. Olesen Synthesis A/S's last inspection go?
The most recent inspection on record closed on 22 November 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Chr. Olesen Synthesis A/S manufacture?
2 registered sites are on record, in Denmark (Hvidovre and Denmark). Every site is listed on this page with the register it came from.
What does Chr. Olesen Synthesis A/S make?
7 molecules are on record against Chr. Olesen Synthesis A/S, including Buprenorphine, Dexamfetamine Sulfate, Hydromorphone and Pramipexole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chr. Olesen Synthesis A/S's GMP?
Current GMP certificates are on record from 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 22 November 2023.

Comparable suppliers

MSN Laboratories shares 2 molecules Apitoria Pharma shares 2 molecules Hetero shares 2 molecules Cipla shares 2 molecules Olon shares 2 molecules

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