Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Wednesday, March 27, 2019
STA Pharmaceutical WuXi STA announces its new drug product manufacturing facility in Waigaoqiao Free Trade Zone of Shanghai has passed its first GMP inspection by the European MPA.
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TCR2 Therapeutics has selected the advanced therapy medicinal products ecosystem in the United Kingdom (UK) to establish a site for global manufacturing systems and capabilities.
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Abzena has signed an agreement to support an integrated CMC program with Lipum, a company developing treatments for chronic inflammatory diseases.
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PCI has announced further investment to expand its flagship manufacturing center in Tredegar, Wales.
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Asymchem announced its Tianjin1 site successfully completed a FDA general GMP reinspection conducted between January 14-18, 2019. No Form 483 was issued.
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Thermo Fisher Scientific is investing $150 million in its Pharma Services business to provide additional capacity for sterile liquid and lyophilized product development and commercial manufacturing.
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Paragon Bioservices has announced the appointment of Thomas VanCott, Ph.D., as Chief Technology and Strategy Officer (CTSO), along with several key promotions and new hires.
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WuXi Biologics has received EMA GMP certificates for the production of Trogarzo™ at its cGMP DS and DP manufacturing facilities in Wuxi city and its cGMP cell banking facilities in Shanghai.
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The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
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Wednesday, March 20, 2019
NJII has signed an Industry Participation Agreement with Pall Corporation to support the development of its BioPharmaceutical Innovation iLab.
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Alcami has launched Alcami Biologics, the organization's new biopharmaceutical development, analytical testing, manufacturing, and packaging enterprise.
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Piramal Critical Care announced the launch of MITIGO™ (Morphine Sulfate Injection, USP – Preservative-free) in 10 mg/mL and 25 mg/mL concentrations in the U.S. market.
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BioVectra announced a five-year, $144.6 million (CAD) expansion project to enhance its Biopharmaceutical capabilities in both Charlottetown, Prince Edward Island and Windsor, Nova Scotia.
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Under a license agreement with the HMRI for development of clinical grade RNA manufacturing services, VGXI announced it has completed all of the partnership’s Phase I initiatives and anticipates Phase II will conclude by 4Q 2019.
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Pii has announced the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth.
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