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.
| 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.
| 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 |
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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