Suppliers / Nipro

Nipro

Japan 2 duplicate records merged Updated 9 July 2026

Nipro is a finished-dose manufacturer based in Japan. It appears in 24 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), EFDA (ET) and NAFDAC (NG). Its GMP standing is certified by NAFDAC (NG).

0
active US DMFs
0
valid CEPs
4
registered plants
24
filings across 4 regulators

Registered plants

Site FDA FEI
Matsubara, United Arab Emirates Not on file
SAN ISIDRO, Peru Not on file
Rubí (Barcelona), Portugal Not on file
DAGANZO DE ARRIBA, Portugal Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 10 None
EFDA (ET) 9 None
NAFDAC (NG) 4 3
BOMRA (BW) 1 None

Questions about Nipro

Does Nipro hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Nipro. It does have 24 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Nipro manufacture?
4 registered sites are on record, in United Arab Emirates, Peru and Portugal (Matsubara, SAN Isidro and Rubí (barcelona) among others). Every site is listed on this page with the register it came from.
Which regulators recognise Nipro's GMP?
Current GMP certificates are on record from NAFDAC (NG). 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

Bushu Pharmaceuticals also in Japan Chugai Pharma Manufacturing also in Japan Eisai also in Japan Hisamitsu Pharmaceutical also in Japan Kyowa Kirin also in Japan

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