RESOLUÇÃO RE Nº 2.107, DE 27 DE Maio DE 2021
| Data de publicação | 31 Maio 2021 |
| Páginas | 196-196 |
| Data | 27 Maio 2021 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO RE Nº 2.107, DE 27 DE Maio DE 2021
A Gerente-Geral de Inspeção e Fiscalização Sanitária, no uso das atribuições que lhe confere o art. 171, aliado ao art. 54, I, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 255, de 10 de dezembro de 2018, considerando o cumprimento dos requisitos de Boas Práticas de Fabricação preconizados em legislação vigente, para a área de Insumos Farmacêuticos, resolve:
Art. 1º Conceder à(s) empresa(s) constante(s) no anexo, a Certificação de Boas Práticas de Fabricação de Insumos Farmacêuticos.
Art. 2º A presente Certificação tem validade de 2 (dois) anos a partir da sua publicação.
Art. 3º Esta Resolução entra em vigor na data de sua publicação.
ANA CAROLINA MOREIRA MARINO ARAÚJO
ANEXO
Fabricante: Aspen Oss B.V.
Endereço: Veersemeer 4, 5347 JN Oss
País: Holanda (Países Baixos) Código único: B.0195
Solicitante: Libbs Farmacêutica Ltda - CNPJ: 61.230.314/0001-75
Autorização de Funcionamento: 1.00.033-3 Expediente(s): 0125299/21-4
Certificado de Boas Práticas de Fabricação de Insumos Farmacêuticos Ativos:
Insumo farmacêutico ativo obtido por síntese química: etinilestradiol
-----------------------------------------------------------------------------------------
Fabricante: Janssen Pharmaceutica NV
Endereço: Janssen Pharmaceuticalaan 3, Geel, B-2440
País: Bélgica Código único: B.0484
Solicitante: Janssen-Cilag Farmacêutica Ltda CNPJ: 51.780.468/0001-87
Autorização de...
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