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Olon宣布并购Capua BioServices,旨在成为欧洲微生物发酵CDMO领头羊

   日期:2019-01-28     来源:美通社    浏览:1761    评论:0    
核心提示:Olon S. p.A. 是全球领先的活性药物成分 (API) 合同开发和制造组织 (CDMO) 和仿制药供应商,今天宣布收购 Capua BioServices S. p. A. 作为其全球足迹不断扩大的一部分,后者是微生物发酵领域 CDMO 服务的全球供应商。
  
 意大利罗达诺 2019 年 1 月 25 日电/美通社/--Olon S. p.A. 是全球领先的活性药物成分 (API) 合同开发和制造组织 (CDMO) 和仿制药供应商,今天宣布收购 Capua BioServices S. p. A.  作为其全球足迹不断扩大的一部分,后者是微生物发酵领域 CDMO 服务的全球供应商。

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Olon 首席执行官 Paolo Tubertini 评论道,' 通过收购 Capua BioServices,Olon 将有机会通过增加新的 CDMO 项目来加速增长,并有望成为欧洲市场微生物发酵 CDMO 的领导者(总发酵能力为 4.500 m3)。它配备了世界级的制造设施和专门的专家团队,将支持我们提供高质量的服务,满足或超出客户的期望。' 

“继 2017 年中收购 Ricerca Biosciences 的化学部门和 2018 年第三季度宣布并于 2019 年第一季度关闭的马哈德(印度)制造场所之后,我们现在已经完成了我们战略计划中的又一步。通过这次收购,Olon 成功完成了他 3 年的发展计划。“

Capua BioServices 是定制微生物工艺开发和制造领域的全球高质量服务提供商。Capua BioServices 为蛋白质、特种小分子和微生物提供专用解决方案,适用于制药、食品、饲料和其他生物工业市场。该位点不含 β-内酰胺,总发酵能力约为 1.400 m3,位于那不勒斯附近的卡普亚(意大利南部),约有 230 名雇员。在过去的 60 年中,该公司根据在多种细菌、酵母和真菌系统方面的丰富经验,建立了跟踪记录。未计划对工作产生影响,Olon 打算投资该工厂并寻求业务发展机会,以优化工厂的利用率并扩大客户群。

关于Olon 

Olon 是意大利一家通过合成和生物工艺生产活性药物成分 (API) 的公司领导者,用于仿制药市场和合同开发和生产 (CDMO) 要求。

与我们的活动相辅相成的是申报资料部门,其专业人员团队负责开发成品制剂 (FDF) 和编制通用技术文件 (CTD) 申报资料。

2017 年营业额为 4 亿美元,仿制药市场有 250 多个原料药(31个CMO项目),化学中间体(33个CMO项目)。

Olon 持有约 130 份美国 DMF 和 50 份 Co。可处理氟化、羰基化、发酵等特殊工艺技术。

Olon 拥有 1500 名员工,其中仅在专业研发团队中就有 200 名员工,基于化学和生物工艺方面的强大知识,Olon 提供完整的集成包和服务,以支持原料药的全面开发,所有产品均为全 cGMP,并具有法规覆盖范围。

总部位于意大利米兰的罗丹诺,Olon 拥有 10 家生产工厂——7 家位于意大利北部,1 家位于西班牙,1 家位于美国,1 家位于印度,均符合国际要求,在德国汉堡、美国新泽西州弗洛勒姆公园和中国上海设有 3 家分公司。

由最重要的国家和国际监管机构定期检查生产地点,并由我们的合作伙伴和客户定期检查。根据 GDUFA,对这些设施进行了 FDA 检查和自我确认。

除药品认证外,Olon 还设有专门的食品级生产区域,并符合 Kosher、Halal 和 FSSC 22 的自 2018-Q2 的要求。

原文

RODANO, Italy, January 25, 2019 /PRNewswire/ -- Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, announced today the acquisition of Capua BioServices S.p.A., a global provider of CDMO services in the field of microbial fermentation, as part of a continuing expansion of its global footprint. 

   
        Paolo Tubertini, CEO of Olon, commented, "By acquiring Capua BioServices, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to be recognized as European Leader in the CDMO of microbial fermentation (total fermentation capacity of 4.500 m3). It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality services that meet or exceed customer expectations. "

 

Following the acquisition of Ricerca Biosciences' Chemical Division in mid-2017 and the manufacturing site in Mahad (India), announced in Q3 2018 with closing in Q1 2019, we have now completed a further step in our strategic plan. With this acquisition Olon has successfully finalized his 3 years' development plan."

 

Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. Capua BioServices offers dedicated solutions for proteins, specialty small molecules and microorganisms for applications in pharma, food, feed and other bio-industrial markets. The site is beta-lactam free with a total fermentation capacity of about 1.400 m3, located in Capua, nearby Naples (South of Italy) with approximately 230 employees. Over the past 60 years, the company has built a track record based on extensive experience in working with a variety of bacterial, yeast and fungal systems. No impact on jobs is planned and Olon intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base.

 

about Olon

 

OLON is an Italian company leader in the production of Active Pharmaceutical Ingredients (APIs) via synthesis and biological processes for the generic market and for contract development and manufacturing (CDMO) requirements.

 

Complementary to our activities is the Dossier Unit, whose team of dedicated professionals work on the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical documents (CTD) dossier.

 

Turnover in 2017 of US$ 400 million, with more than 250 APIs (31 under CMO) for the Generic market and 33 chemical intermediates (under CMO).

 

Olon is holder of about 130 active US DMFs and 50 granted CoS. and is able to handle several particular process technologies, such as Fluorination, Carbonylation and Fermentation.

 

With 1,500 employees, of which 200 alone are in the specialized R&D team, Olon offers complete integrated packages and services to support full development of APIs based on strong knowledge in both Chemical and Biological process, all in full cGMPs and with regulatory coverage.

 

Headquartered in Rodano (Milan, Italy), Olon has 10 manufacturing facilities - 7 located in Northern Italy, 1 in Spain 1 in USA and 1 in India, all compliant with international requirements, and 3 branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China).

 

The manufacturing sites are regularly inspected by the most important national and international Authorities, and regularly audited by our partners and customers. The facilities are FDA-inspected and self-identified under GDUFA.

 

In addition to pharmaceutical certifications, Olon has dedicated areas for food-grade manufacturing and complies with Kosher, Halal and from 2018-Q2 with FSSC 22.000.

 
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