RESOLUÇÃO RE Nº 1.210, DE 14 DE Abril DE 2022
| Páginas | 282-282 |
| Data de publicação | 18 Abril 2022 |
| Data | 14 Abril 2022 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Section | DO1 |
RESOLUÇÃO RE Nº 1.210, DE 14 DE Abril DE 2022
A Gerente-Geral de Inspeção e Fiscalização Sanitária, Substituta, no uso das atribuições que lhe confere o art. 140, aliado ao art. 203, I, § 1º do Regimento Interno aprovado pela Resolução de Diretoria Colegiada - RDC nº 585, de 10 de dezembro de 2021, 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 Ativos.
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.
ALESSANDRA PAIXÃO DIAS
ANEXO
Fabricante: Abbvie Operations Singapore Pte. Ltd.
Endereço: 23 Tuas South Avenue 6, 637022.
País: Cingapura Código Único: A.001405
Solicitante: Abbvie Farmacêutica Ltda. CNPJ: 15.800.545/0001-50
Expediente(s): 3262285/21-8
Certificado de Boas Práticas de Fabricação de Insumos Farmacêuticos Ativos:
Insumos farmacêuticos ativos biológicos: adalimumabe.
-----------------------------------------------------------------------------------------
Fabricante: Biocon Biologics Limited
Endereço: 20th Km Hosur Road, Electronics City, Bangalore 560 100
País: Índia Código Único: A.000105
Solicitante: Mylan...
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