NerPharMa

Italy 2 duplicate records merged Updated 9 July 2026

NerPharMa is an API and finished-dose manufacturer based in Italy. It holds 3 active US drug master files and one valid CEP across a filed portfolio of 3 molecules. Its filings concentrate with ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by EMA and MFDS (Korea).

active US DMFs

valid CEPs

registered plants

filings across 2 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
MILANO (MI), Italy	Not on file
Nerviano, Italy	Not on file
MILANO (MILAO), Italy	Not on file
MILANO, Italy	Not on file

What they file, and where

Molecule	Regulators	Docs
Bendamustine	SFDA (Saudi Arabia), US FDA	2
Carmustine	EDQM, US FDA	2
Melphalan	US FDA	1

Also appears on these molecule pages

Bendamustine API Carmustine API Cladribine finished dose Melphalan API Thiotepa finished dose

Filings and GMP by regulator

Regulator	Filings	GMP certificates
ARCSA (EC)	2	None
INVIMA (CO)	1	None
EMA	None	4
MFDS (Korea)	None	2

Questions about NerPharMa

Does NerPharMa hold a US DMF or a CEP?

NerPharMa holds 3 active US drug master files 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.

Where does NerPharMa manufacture?

4 registered sites are on record, in Italy (Milano (mi), Nerviano and Milano (milao) among others). Every site is listed on this page with the register it came from.

What does NerPharMa make?

3 molecules are on record against NerPharMa, including Bendamustine, Carmustine and Melphalan. Each links through to that molecule's full manufacturer list.

Which regulators recognise NerPharMa's GMP?

Current GMP certificates are on record from EMA and MFDS (Korea). 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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Comparable suppliers

ChemPacific shares 3 molecules MSN Laboratories shares 2 molecules Apitoria Pharma shares 2 molecules Hetero shares 2 molecules Olon shares 2 molecules

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