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MILAN, Italy, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Dipharma Francis S.r.l. (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today another new production site of the Group, the facility located in Caronno Pertusella, near Milan (Italy), has received the Good Manufacturing Practice (GMP) certification - CBPF (Certificado de Boas Práticas de Fabricação) - from the Regulatory Authority of Brazil, ANVISA (Agência Nacional de Vigilância Sanitária).
意大利米兰,2023年10月26日(GLOBE NEWSWIRE)-领先的合同开发和制造组织(CDMO)和全球活性药物成分制造商Dipharma Francis S.r.l.(Dipharma)今天宣布该集团的另一个新生产基地,该设施位于米兰(意大利)附近的Caronno Pertusella,已获得巴西监管机构ANVISA(AgênciaNacional deVigilânciaSanitária)的良好生产规范(GMP)认证-CBPF(CertificadodeBoasPráticasdeFabricação)。
This authorization joins the previous one, obtained in November 2022, by the Dipharma Italian site located in Baranzate (Milan), and certifies Dipharma world-class quality system, which has been widely recognized by regulatory authorities. The Caronno Pertusella facility has been regularly and successfully inspected by the US FDA and the Italian Ministry of Health (AIFA) for more than 50 years.
该授权加入了2022年11月由位于Baranzate(米兰)的Dipharma意大利站点获得的前一个授权,并证明了Dipharma世界级质量体系,该体系已得到监管机构的广泛认可。Caronno Pertusella设施已经由美国FDA和意大利卫生部(AIFA)定期成功检查了50多年。
“We are very proud to have reached another regulatory milestone: this second successful completion of the ANVISA certification recognizes another Dipharma site as being in compliance with the GMP requisites as foreseen by the Brazilian requirements,” said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l.
Dipharma Francis S.r.l.首席执行官Jorge Nogueira说:“我们非常自豪地达到了另一个监管里程碑:第二次成功完成ANVISA认证,确认另一个Dipharma站点符合巴西要求所预见的GMP要求。”。
— “Our Company is committed to providing innovative and competitive solutions to our customers and this achievement once again certifies we are an ideal partner for registering new applications at ANVISA.” About the Dipharma Francis GroupWith revenues over €140 million, the Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with more than 550 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A.
-“我们的公司致力于为客户提供创新和有竞争力的解决方案,这一成就再次证明我们是在ANVISA注册新申请的理想合作伙伴。”关于收入超过1.4亿欧元的Dipharma Francis集团,Dipharma集团是全球CDMO和API和中间体的领先制造商,位于美国的550多名熟练和高度承诺的员工,4家cGMP工厂。
and Italy, plus sales offices in Italy, the U.S.A. and China. The full.
和意大利,以及意大利,美国和中国的销售办事处。完整。