Suppliers / Proto Chemicals

Proto Chemicals

Switzerland Updated 9 July 2026

Proto Chemicals is an API manufacturer based in Switzerland. It holds one valid CEP. Its GMP standing is certified by EMA.

0
active US DMFs
1
valid CEPs
3
registered plants
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Mitlodi, Switzerland Not on file
Mitloedi, Switzerland Not on file
Mitlödi, Switzerland Not on file

What they file, and where

Molecule Regulators Docs
Tramadol EDQM 1

Also appears on these molecule pages

Tramadol API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
EMA None 2

Questions about Proto Chemicals

Does Proto Chemicals hold a US DMF or a CEP?
Proto Chemicals holds 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.
Where does Proto Chemicals manufacture?
3 registered sites are on record, in Switzerland (Mitlodi, Mitloedi and Mitlödi). Every site is listed on this page with the register it came from.
What does Proto Chemicals make?
1 molecule is on record against Proto Chemicals, including Tramadol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Proto Chemicals's GMP?
Current GMP certificates are on record from EMA. 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. Proto Chemicals comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Comparable suppliers

Apitoria Pharma shares 1 molecule Zydus Lifesciences shares 1 molecule Ipca Laboratories shares 1 molecule Jubilant Biosys shares 1 molecule Macleods Pharmaceuticals 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