RESOLUÇÃO RE Nº 377, DE 28 DE Janeiro DE 2021
| Data de publicação | 01 Fevereiro 2021 |
| Páginas | 137-137 |
| Data | 28 Janeiro 2021 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,4ª Diretoria,Gerência-Geral de Inspeção e Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO RE Nº 377, DE 28 DE Janeiro 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: BAYER S.A. - CNPJ: 18.459.628/0001-15 - AUTORIZ/MS: 1070568
ENDEREÇO: RUA DOMINGOS JORGE, Nº 1100 PREDIO 9501 3º ANDAR
MUNICÍPIO: SÃO PAULO - UF: SP - EXPEDIENTE: 2387862/20-1
CERTIFICADO DE BOAS PRÁTICAS DE FABRICAÇÃO DE MEDICAMENTOS: Sólidos não estéreis: Comprimidos
Sólidos não estéreis (Embalagem primária; Embalagem secundária): Cápsulas; Cápsulas Moles; Comprimidos Revestidos
Sólidos não estéreis (Hormônios) (Embalagem secundária)
Sólidos não estéreis (Embalagem secundária)
.........................................
EMPRESA FABRICANTE: ALKERMES, INC.
ENDEREÇO: 265 OLINGER CIRCLE, WILMINGTON, OHIO (OH) 45177-2484 - PAÍS: ESTADOS UNIDOS DA AMÉRICA - CÓDIGO ÚNICO: A.0022
EMPRESA SOLICITANTE: JANSSEN-CILAG FARMACÊUTICA LTDA - CNPJ: 51.780.468/0001-87
AUTORIZ/MS: 1012361 - EXPEDIENTE(s): 1652673/20-2
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