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

Comparing suppliers?

Choose your molecules and target markets. NerPharMa comes back tiered against every other supplier able to file there.

Start for free

No sales call.

Sources on this page

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