Suppliers / Labiana Pharmaceuticals S L U

Labiana Pharmaceuticals S L U

Spain Updated 9 July 2026

Labiana Pharmaceuticals S L U is an API and finished-dose manufacturer based in Spain. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its filings concentrate with MPA (SE), MINSA (CR) and AEMPS (ES). Its GMP standing is certified by NAFDAC (NG), EMA and AEMPS (ES).

0
active US DMFs
2
valid CEPs
4
registered plants
17
filings across 9 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
Barcelona, United Arab Emirates Not on file
S.L.U. Corbera de Llobregat, Spain Not on file
Barcelona, Spain Not on file
Corbera De Llobregat, Spain Not on file

What they file, and where

Molecule Regulators Docs
Fosfomycin EDQM 1
Fosfomycin Trometamol EDQM 1

Also appears on these molecule pages

Empagliflozin finished dose Fosfomycin API Gelatin contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 3 None
MINSA (CR) 3 None
AEMPS (ES) 3 1
INFARMED (PT) 2 None
ARCSA (EC) 2 None
JFDA (JO) 1 None
NAFDAC (NG) None 1
EMA None 1

Questions about Labiana Pharmaceuticals S L U

Does Labiana Pharmaceuticals S L U hold a US DMF or a CEP?
Labiana Pharmaceuticals S L U holds 2 valid CEPs. 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 Labiana Pharmaceuticals S L U manufacture?
4 registered sites are on record, in United Arab Emirates and Spain (Barcelona, S.l.u. Corbera De Llobregat and Corbera De Llobregat among others). Every site is listed on this page with the register it came from.
What does Labiana Pharmaceuticals S L U make?
2 molecules are on record against Labiana Pharmaceuticals S L U, including Fosfomycin and Fosfomycin Trometamol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Labiana Pharmaceuticals S L U's GMP?
Current GMP certificates are on record from NAFDAC (NG), EMA and AEMPS (ES). 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.

Comparing suppliers?

Choose your molecules and target markets. Labiana Pharmaceuticals S L U comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Comparable suppliers

Honour Lab shares 1 molecule F.I.S. Fabbrica Italiana Sintetici shares 1 molecule Quimica Sintetica shares 1 molecule Ercros shares 1 molecule Zach System shares 1 molecule

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