RESOLUÇÃO-RE nº 762, DE 27 DE MARÇO DE 2019
| Data | 27 Março 2019 |
| Páginas | 38-38 |
| Data de publicação | 01 Abril 2019 |
| Órgão | Suplemento ANVISA,Agência Nacional de Vigilância Sanitária,Diretoria de Controle e Monitoramento Sanitários,Gerência-Geral de Inspeção e Fiscalização Sanitária |
RESOLUÇÃO-RE nº 762, DE 27 DE MARÇO 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 pela 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 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.
RONALDO LUCIO PONCIANO GOMES
ANEXO
EMPRESA: ZODIAC PRODUTOS FARMACÊUTICOS S/A - CNPJ: 55.980.684/0001-27 - AUTORIZ/MS: 1022141
ENDEREÇO: RODOVIA VEREADOR ABEL FABRÍCIO DIAS, Nº 3400
MUNICÍPIO: PINDAMONHANGABA - UF: SP - EXPEDIENTE: 0974968/18-3
CERTIFICADO DE BOAS PRÁTICAS DE FABRICAÇÃO DE MEDICAMENTOS: Sólidos não estéreis: Cápsulas; Comprimidos; Pós
Sólidos não estéreis (Embalagem primária): Comprimidos Revestidos
Sólidos não estéreis (Embalagem secundária)
Sólidos não estéreis (Citotóxicos) (Embalagem secundária)
.........................................
EMPRESA FABRICANTE: HISAMITSU PHARMACEUTICAL CO., INC.
ENDEREÇO: TASHIRO DAIKAN-MACHI 408, 841-0017 TOSU-SHI, SAGA - PAÍS: JAPÃO - CÓDIGO ÚNICO: A.0301
EMPRESA SOLICITANTE: HISAMITSU FARMACÊUTICA DO BRASIL LTDA - CNPJ: 49.383.250/0001-47
AUTORIZ/MS: 1010525 - EXPEDIENTE(s): 0915650/18-0
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