Suppliers / Sp Quimica

Sp Quimica

Spain Updated 9 July 2026

Sp Quimica is an API manufacturer based in Spain. It holds one active US drug master file. Its filings concentrate with INFARMED (PT), DIGEMAPS (DO) and EMA. Its GMP standing is certified by INFARMED (PT), AEMPS (ES) and INVIMA (CO), among 4 authorities.

1
active US DMFs
0
valid CEPs
12
registered plants
2,376
filings across 12 regulators

Registered plants

Site FDA FEI
Bogota D.C., Colombia Not on file
Madrid, Spain Not on file
LA VICTORIA, Peru Not on file
LA VICTORIA, Peru Not on file
LA VICTORIA, Peru Not on file
VICTOR LARCO HERRERA, Peru Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Benserazide US FDA 1

Also appears on these molecule pages

Benserazide API

Filings and GMP by regulator

Regulator Filings GMP certificates
INFARMED (PT) 1,671 8
DIGEMAPS (DO) 393 None
EMA 134 None
INHRR (VE) 93 None
INVIMA (CO) 57 1
ARCSA (EC) 9 1
AEMPS (ES) None 2

Questions about Sp Quimica

Does Sp Quimica hold a US DMF or a CEP?
Sp Quimica holds 1 active US drug master file. 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 Sp Quimica manufacture?
12 registered sites are on record, in Colombia, Spain and Peru (Bogota D.c., Madrid and LA Victoria among others). Every site is listed on this page with the register it came from.
What does Sp Quimica make?
1 molecule is on record against Sp Quimica, including Benserazide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sp Quimica's GMP?
Current GMP certificates are on record from INFARMED (PT), AEMPS (ES), INVIMA (CO) and ARCSA (EC). 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