Suppliers / Fine Organics

Fine Organics

United Kingdom Updated 9 July 2026

Fine Organics is an API manufacturer based in United Kingdom. It holds one active US drug master file and one valid CEP. Its GMP standing is certified by MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 17 June 2022 as VAI. Customs aggregates show $618K of exports covering 9 molecules to 4 destinations in 2025.

1
active US DMFs
1
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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 June 2022 VAI US FDA
  • 15 February 2017 NAI US FDA
  • 7 July 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Middlesbrough, United Kingdom Not on file
United Kingdom, United Kingdom 3002807000

What they file, and where

Molecule Regulators Docs
Ketamine EDQM, US FDA 2

Also appears on these molecule pages

Ketamine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $29K 2
2025 Not reported $618K 4
2024 Not reported $1.7M 6
2023 Not reported $3.7M 10

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Fine Organics

Does Fine Organics hold a US DMF or a CEP?
Fine Organics holds 1 active US drug master file and 1 valid CEP. 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 Fine Organics FDA-registered?
One site operated by Fine Organics 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 Fine Organics's last inspection go?
The most recent inspection on record closed on 17 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Fine Organics manufacture?
2 registered sites are on record, in United Kingdom (Middlesbrough and United Kingdom). Every site is listed on this page with the register it came from.
What does Fine Organics make?
1 molecule is on record against Fine Organics, including Ketamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fine Organics's GMP?
Current GMP certificates are on record from MHRA (UK). 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 17 June 2022.

Comparable suppliers

Maithri Drugs shares 1 molecule Gland Pharma shares 1 molecule Harman Finochem shares 1 molecule Supriya Lifescience shares 1 molecule Arevipharma shares 1 molecule

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
Customs aggregates
Export values, molecule and destination counts