Suppliers / Bsp Pharmaceuticals

Bsp Pharmaceuticals

Italy Updated 9 July 2026

Bsp Pharmaceuticals is a finished-dose manufacturer based in Italy. It appears in 36 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with INVIMA (CO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ANVISA (Brazil), EAEU_EEC and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 12 November 2021 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
36
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 12 November 2021 VAI US FDA
  • 20 October 2017 VAI US FDA
  • 16 December 2016 VAI US FDA
  • 26 June 2015 VAI US FDA
  • 5 December 2012 VAI US FDA
  • 12 November 2010 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
LATINA (LT), Italy Not on file
LATINA, Italy Not on file
LATINA, Italy Not on file
Italy, Italy 3007255826

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 12 None
ARCSA (EC) 11 None
NPRA (MY) 6 None
MINSA (CR) 4 None
JFDA (JO) 2 None
US FDA 1 None
ANVISA (Brazil) None 13
EAEU_EEC None 4
MFDS (Korea) None 2
EMA None 2

Comparing suppliers?

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

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 12 November 2021.

Sources on this page

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