RESOLUÇÃO-RE Nº 259, DE 31 DE JANEIRO DE 2019
| Data de publicação | 04 Fevereiro 2019 |
| Data | 31 Janeiro 2019 |
| Páginas | 33-33 |
| Órgão | Suplemento ANVISA,Agência Nacional de Vigilância Sanitária,Diretoria de Controle e Monitoramento Sanitários,Gerência-Geral de Inspeção e Fiscalização Sanitária |
RESOLUÇÃO-RE Nº 259, DE 31 DE JANEIRO DE 2019
O Gerente-Geral de Inspeção e Fiscalização Sanitária Substituto, no uso das atribuições que lhe confere o art. 171, aliado ao art. 54, I, § 1º do Regimento Interno aprovado nos termos do Anexo I da Resolução da Diretoria Colegiada - RDC n° 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 às Empresas constantes 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.
RONALDO LUCIO PONCIANO GOMES
ANEXO
EMPRESA: BAYER S.A. - CNPJ: 18.459.628/0001-15 - AUTORIZ/MS: 1070568
ENDEREÇO: RUA DOMINGOS JORGE, N° 1100 PREDIO 9501 3º ANDAR
MUNICÍPIO: SÃO PAULO - UF: SP - EXPEDIENTE: 0511476/18-4
CERTIFICADO DE BOAS PRÁTICAS DE FABRICAÇÃO DE MEDICAMENTOS: Produtos estéreis: Embalagem secundária
.........................................
EMPRESA FABRICANTE: MERCK S.A DE C.V
ENDEREÇO: CALLE 5, Nº 7, COL. FRACCIONAMIENTO INDUSTRIAL ALCE BLANCO, C.P.53370, NAUCALPAN DE JUÁREZ, NAUCALPAN - PAÍS: MÉXICO - CÓDIGO ÚNICO: A.0406
EMPRESA SOLICITANTE: BIOHAGEN FARMACEUTICA DO BRASIL LTDA. - CNPJ: 28.813.375/0001-90
AUTORIZ/MS: 1173223 - EXPEDIENTE(s): 0507208/18-5
CERTIFICADO DE BOAS PRÁTICAS DE FABRICAÇÃO DE MEDICAMENTOS: Sólidos não estéreis (Granel): Comprimidos Revestidos
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