RESOLUÇÃO-RE Nº 521, DE 28 DE FEVEREIRO DE 2019
| Data | 28 Fevereiro 2019 |
| Data de publicação | 06 Março 2019 |
| Páginas | 49-49 |
| Órgão | Suplemento ANVISA,Agência Nacional de Vigilância Sanitária,Diretoria de Controle e Monitoramento Sanitários,Gerência-Geral de Inspeção e Fiscalização Sanitária |
RESOLUÇÃO-RE Nº 521, DE 28 DE FEVEREIRO 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 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 02 (dois) anos a partir da sua publicação.
Art. 3º Esta Resolução entra em vigor na data de sua publicação.
RONALDO LUCIO PONCIANO GOMES
ANEXO
Fabricante: Arevipharma GmbH
Endereço: Meissner Strasse, Radebeul, Nº 35 01445
País: Alemanha
Solicitante: Mylan Laboratórios Ltda. CNPJ: 11.643.096/0001-22
Autorização de Funcionamento: 1.08.830-7 Expediente(s): 0892831/18-2
Certificado de Boas Práticas de Fabricação de Insumos Farmacêuticos Ativos:
Insumo(s) farmacêutico(s) ativo(s) obtido(s) por síntese química:
clozapina
Obs.: A fabricação deste insumo farmacêutico ativo envolve ainda outras etapas de fabricação realizadas pelas seguintes plantas, que também devem possuir Certificado de Boas Práticas de Fabricação válido, conforme estabelece a RDC 69/2014:
Etapa de purificação:
Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel - Switzerland
e Novartis Ringaskiddy, Ltd. Ringaskiddy Co. Cork - Ireland
Etapa de moagem:
Novartis Pharma...
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