Suppliers / Fine Chemicals Corporation (PTY)

Fine Chemicals Corporation (PTY)

South Africa 8C9.DU 2 duplicate records merged Updated 9 July 2026

Fine Chemicals Corporation (PTY) is an API manufacturer based in South Africa. It holds 16 active US drug master files across a filed portfolio of 12 molecules. Its filings concentrate with MINSA (CR) and EEC_EAEU. Its GMP standing is certified by ZLG (DE), SAHPRA (ZA) and US FDA. Its most recent recorded inspection, by US FDA, closed on 4 April 2025 as VAI.

16
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
4
filings across 2 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

  • 4 April 2025 VAI US FDA
  • 6 July 2018 NAI US FDA
  • 9 May 2014 NAI US FDA
  • 1 September 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Bremen, Germany Not on file
Arada Sub City, Ethiopia Not on file
South Africa, South Africa 3002806969
Cape Town, South Africa Not on file

What they file, and where

Molecule Regulators Docs
Azathioprine US FDA 2
Baclofen US FDA 2
Fluphenazine US FDA 2
Ropivacaine US FDA 2
Benzatropine US FDA 1
Levosalbutamol US FDA 1
Methazolamide US FDA 1
Penbutolol US FDA 1
Remifentanil US FDA 1
Scopolamine US FDA 1
Show all 12 molecules on file
Thiothixene US FDA 1
Vincristine US FDA 1

Also appears on these molecule pages

Azathioprine API Baclofen API Benzatropine API Fluphenazine API Levosalbutamol API Remifentanil API Ropivacaine API Scopolamine API Vincristine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
EEC_EAEU 1 None
ZLG (DE) None 2
SAHPRA (ZA) None 2
US FDA None 1

Questions about Fine Chemicals Corporation (PTY)

Does Fine Chemicals Corporation (PTY) hold a US DMF or a CEP?
Fine Chemicals Corporation (PTY) holds 16 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 Fine Chemicals Corporation (PTY) FDA-registered?
One site operated by Fine Chemicals Corporation (PTY) 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 Chemicals Corporation (PTY)'s last inspection go?
The most recent inspection on record closed on 4 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Fine Chemicals Corporation (PTY) manufacture?
4 registered sites are on record, in Germany, Ethiopia and South Africa (Bremen, Arada Sub City and South Africa among others). Every site is listed on this page with the register it came from.
What does Fine Chemicals Corporation (PTY) make?
12 molecules are on record against Fine Chemicals Corporation (PTY), including Azathioprine, Baclofen, Fluphenazine and Ropivacaine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fine Chemicals Corporation (PTY)'s GMP?
Current GMP certificates are on record from ZLG (DE), SAHPRA (ZA) 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 4 April 2025.

Comparable suppliers

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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