Suppliers / Opella Healthcare Brazil Ltda

Opella Healthcare Brazil Ltda

Brazil Updated 9 July 2026

Opella Healthcare Brazil Ltda is a finished-dose manufacturer based in Brazil. It appears in 909 regulatory filings across 31 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and ANSM (FR). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and EMA, among 6 authorities.

0
active US DMFs
0
valid CEPs
11
registered plants
909
filings across 31 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
Origgio (VA), United Arab Emirates Not on file
Compiegne, United Arab Emirates Not on file
SUZANO, Brazil Not on file
Risch, Switzerland Not on file
Suzano (Estado De Sao Paulo), Colombia Not on file
Compiegne, France Not on file

5 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 218 None
EMA 170 3
ANSM (FR) 68 10
INFARMED (PT) 67 None
ANVISA (Brazil) 57 4
AEMPS (ES) 50 None
HSA (SG) None 3
INVIMA (CO) None 1
NAFDAC (NG) None 1

Questions about Opella Healthcare Brazil Ltda

Does Opella Healthcare Brazil Ltda hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Opella Healthcare Brazil Ltda. It does have 909 filings with 31 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Opella Healthcare Brazil Ltda manufacture?
11 registered sites are on record, in United Arab Emirates, Brazil, Switzerland and Colombia (Origgio (va), Compiegne and Suzano among others). Every site is listed on this page with the register it came from.
Which regulators recognise Opella Healthcare Brazil Ltda's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), EMA, HSA (SG), INVIMA (CO) and 1 more. 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