Suppliers / Galderma

Galderma

Brazil Updated 9 July 2026

Galderma is a finished-dose manufacturer based in Brazil. It appears in 807 regulatory filings across 30 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, AIFA (IT) and ANVISA (Brazil). Its GMP standing is certified by ANVISA (Brazil), HSA (SG) and ANSM (FR), among 4 authorities.

0
active US DMFs
0
valid CEPs
6
registered plants
807
filings across 30 regulators

Registered plants

Site FDA FEI
HORTOLANDIA, Brazil Not on file
Zug, Switzerland Not on file
Hortolandia, Colombia Not on file
BIOT, France Not on file
LEGANÉS, Portugal Not on file
Alcochete, Portugal Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 128 None
AIFA (IT) 80 None
ANVISA (Brazil) 75 3
MHRA (UK) 69 None
Health Canada 68 None
INHRR (VE) 58 None
HSA (SG) None 2
ANSM (FR) None 2
INVIMA (CO) None 1

Questions about Galderma

Does Galderma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Galderma. It does have 807 filings with 30 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Galderma manufacture?
6 registered sites are on record, in Brazil, Switzerland, Colombia and France (Hortolandia, Zug and Hortolandia among others). Every site is listed on this page with the register it came from.
Which regulators recognise Galderma's GMP?
Current GMP certificates are on record from ANVISA (Brazil), HSA (SG), ANSM (FR) and INVIMA (CO). 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