RESOLUÇÃO RE Nº 4.402, DE 25 DE Novembro DE 2021
| Data | 25 Novembro 2021 |
| Páginas | 469-469 |
| Data de publicação | 29 Novembro 2021 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO RE Nº 4.402, DE 25 DE Novembro DE 2021
A Gerente-Geral de Inspeção e Fiscalização Sanitária, Substituta, 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 Medicamentos, resolve:
Art. 1º Conceder à(s) Empresa(s) constante(s) no ANEXO, a Certificação de Boas Práticas de Fabricação de Medicamentos.
Art. 2º A presente Certificação terá 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
EMPRESA FABRICANTE: ZENTIVA K.S.
ENDEREÇO: U KABELOVNY 130, 102 37 PRAHA 10- DOLNÍ MECHOLUPY - PAÍS: TCHECA, REPÚBLICA - CÓDIGO ÚNICO: A.000701
EMPRESA SOLICITANTE: SANOFI MEDLEY FARMACÊUTICA LTDA. - CNPJ: 10.588.595/0010-92
AUTORIZ/MS: 1083267 - EXPEDIENTE(s): 0952182/21-1
CERTIFICADO DE BOAS PRÁTICAS DE FABRICAÇÃO DE MEDICAMENTOS: Sólidos não estéreis: Cápsulas
.........................................
EMPRESA FABRICANTE: OCTAPHARMA AB
ENDEREÇO: LARS FORSSELLS GATA 23, STOCKHOLM, 11275 - PAÍS: SUÉCIA - CÓDIGO...
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