Suppliers / Macfarlan Smith

Macfarlan Smith

United Kingdom reconciled across 5 public records · 1 entities Updated 9 July 2026

Macfarlan Smith is an API manufacturer based in United Kingdom. It holds 5 active US drug master files and 20 valid CEPs across a filed portfolio of 17 molecules. Its GMP standing is certified by EDQM and MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 29 November 2021 as VAI.

5
active US DMFs
20
valid CEPs
3
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 November 2021 VAI US FDA
  • 10 November 2017 VAI US FDA
  • 4 September 2015 VAI US FDA
  • 13 April 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Annan, United Kingdom Not on file
Edinburgh, United Kingdom Not on file
United Kingdom, United Kingdom 3002807530

What they file, and where

Molecule Regulators Docs
Buprenorphine EDQM, US FDA 4
Fentanyl EDQM, SFDA (Saudi Arabia) 4
Apomorphine EDQM, SFDA (Saudi Arabia), US FDA 3
Morphine EDQM, SFDA (Saudi Arabia) 3
Naloxone EDQM, SFDA (Saudi Arabia), US FDA 3
Oxycodone EDQM, SFDA (Saudi Arabia) 3
Codeine EDQM 2
Methadone EDQM, SFDA (Saudi Arabia) 2
Naltrexone EDQM, US FDA 2
Alfentanil EDQM 1
Show all 17 molecules on file
Cocaine EDQM 1
Dihydrocodeine EDQM 1
Hydromorphone EDQM 1
Methylphenidate EDQM 1
Morphine Hemisulfate 2.5-Hydrate EDQM 1
Remifentanil EDQM 1
Sufentanil EDQM 1

Also appears on these molecule pages

Buprenorphine API Codeine API Fentanyl API Hydromorphone API Methadone API Methylphenidate API Morphine API Naloxone API Naltrexone API Oxycodone API Remifentanil API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
EDQM None 20
MHRA (UK) None 2

Questions about Macfarlan Smith

Does Macfarlan Smith hold a US DMF or a CEP?
Macfarlan Smith holds 5 active US drug master files and 20 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 Macfarlan Smith FDA-registered?
One site operated by Macfarlan Smith 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 Macfarlan Smith's last inspection go?
The most recent inspection on record closed on 29 November 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Macfarlan Smith manufacture?
3 registered sites are on record, in United Kingdom (Annan, Edinburgh and United Kingdom). Every site is listed on this page with the register it came from.
What does Macfarlan Smith make?
17 molecules are on record against Macfarlan Smith, including Buprenorphine, Fentanyl, Apomorphine and Morphine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Macfarlan Smith's GMP?
Current GMP certificates are on record from EDQM and 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.

Comparing suppliers?

Choose your molecules and target markets. Macfarlan Smith comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 29 November 2021.

Comparable suppliers

Specgx shares 10 molecules Noramco shares 8 molecules Veranova Lp shares 7 molecules Chattem Chemicals shares 7 molecules Rusan Pharma shares 5 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