Suppliers / Abiogen Pharma

Abiogen Pharma

Italy 382 employees Updated 9 July 2026

Abiogen Pharma is a contract manufacturer based in Italy. It holds one active US drug master file and 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with AIFA (IT), EDE (AE) and EMA. Its GMP standing is certified by EMA and EAEU_EEC.

1
active US DMFs
2
valid CEPs
2
registered plants
478
filings across 14 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
Pisa, United Arab Emirates Not on file
PISA, Italy Not on file

What they file, and where

Molecule Regulators Docs
Clodronate Disodium Tetrahydrate EDQM 2
Neridronic Acid US FDA 1

Also appears on these molecule pages

Calci contract manufacturing Flurbiprofen contract manufacturing Xylometazoline contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 219 None
EDE (AE) 179 None
EMA 40 1
Health Canada 9 None
MPA (SE) 6 None
AEMPS (ES) 5 None
EAEU_EEC None 1

Questions about Abiogen Pharma

Does Abiogen Pharma hold a US DMF or a CEP?
Abiogen Pharma holds 1 active US drug master file and 2 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.
Where does Abiogen Pharma manufacture?
2 registered sites are on record, in United Arab Emirates and Italy (Pisa and Pisa). Every site is listed on this page with the register it came from.
What does Abiogen Pharma make?
2 molecules are on record against Abiogen Pharma, including Clodronate Disodium Tetrahydrate and Neridronic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Abiogen Pharma's GMP?
Current GMP certificates are on record from EMA and EEC (Eurasian Economic Union). 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