Suppliers / Sasol Germany

Sasol Germany

Germany Updated 9 July 2026

Sasol Germany is an API manufacturer based in Germany. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by ZLG (DE).

1
active US DMFs
1
valid CEPs
3
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Germany, Germany 3010599768
Marl, Germany Not on file
Brunsbüttel, Germany Not on file

What they file, and where

Molecule Regulators Docs
Docosanol US FDA 1
Macrogols EDQM 1

Also appears on these molecule pages

Docosanol API

Filings and GMP by regulator

Regulator Filings GMP certificates
ZLG (DE) None 6

Questions about Sasol Germany

Does Sasol Germany hold a US DMF or a CEP?
Sasol Germany 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 Sasol Germany FDA-registered?
One site operated by Sasol Germany 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.
Where does Sasol Germany manufacture?
3 registered sites are on record, in Germany (Germany, Marl and Brunsbüttel). Every site is listed on this page with the register it came from.
What does Sasol Germany make?
2 molecules are on record against Sasol Germany, including Docosanol and Macrogols. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sasol Germany's GMP?
Current GMP certificates are on record from ZLG (DE). 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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates