Suppliers / Dipharma

Dipharma

Italy 38 employees Updated 9 July 2026

Dipharma is an API manufacturer based in Italy. It holds 6 active US drug master files across a filed portfolio of 5 molecules. Its filings concentrate with DKMA (DK), SWISSMEDIC (CH) and ANSM (FR).

6
active US DMFs
0
valid CEPs
1
registered plants
13
filings across 3 regulators

Registered plants

Site FDA FEI
Chiasso, Switzerland Not on file

What they file, and where

Molecule Regulators Docs
Sapropterin US FDA 2
Carglumic Acid US FDA 1
Migalastat US FDA 1
Miglustat US FDA 1
Nitisinone US FDA 1

Also appears on these molecule pages

Carglumic Acid API Miglustat API

Filings and GMP by regulator

Regulator Filings GMP certificates
DKMA (DK) 7 None
SWISSMEDIC (CH) 5 None
ANSM (FR) 1 None

Questions about Dipharma

Does Dipharma hold a US DMF or a CEP?
Dipharma holds 6 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.
Where does Dipharma manufacture?
1 registered site is on record, in Switzerland (Chiasso). Every site is listed on this page with the register it came from.
What does Dipharma make?
5 molecules are on record against Dipharma, including Sapropterin, Carglumic Acid, Migalastat and Miglustat. Each links through to that molecule's full manufacturer list.
Where does Dipharma file?
Filings are on record with DKMA (DK), SWISSMEDIC (CH) and ANSM (FR), 13 in total.

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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Comparable suppliers

Matrix Pharmacorp shares 1 molecule Apicore shares 1 molecule Navinta shares 1 molecule Recordati Industria Chimica e Farmaceutica shares 1 molecule Novitium Pharma 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