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Manufacturing

Set Alert for Manufacturing

EU Must Stop Offshoring Of Essential Medicines, Say Trade Groups

Current EU policy discourages the domestic manufacturing of essential medicines, say Medicines for Europe and the European Fine Chemicals Group. The associations have called for “immediate, robust and ambitious” policy change to drive manufacturing back home.

Manufacturing Policy

Endo Partners With US Government On Critical Medicines

Endo subsidiary Par Sterile Products will expand its Rochester, Michigan facility to begin the fill-finish manufacturing of both mRNA and adenovirus vaccines. Around three-quarters of the project’s expected $120m total costs are being funded by the US government as part of larger efforts to boost the country’s domestic supply of essential medicines.

Deals Manufacturing

Sawai Maintains Strong Domestic Performance, Continues To Flounder In US

Sawai’s Q2 results mirrored those of Q1, with a strong performance in Japan but a weak one in the US. The firm is continuing to focus on establishing new production facilities in both territories.

Sales & Earnings Strategy

How The US FDA Honed Remote Tools To Assess Facilities During COVID Inspection Hiatus

FDA officials outline the impact of using alternative tools to assess manufacturing facilities amid COVID-19 and share key experiences around these, including with remote interactive evaluations.

Manufacturing Regulation

European Industry Urges State Aid Changes To Allow COVID Recovery

A five-year period of temporary relief from EU state aid rules should be introduced for countries willing to invest in API and medicine production, Medicines for Europe has urged, insisting that current restrictions do not allow the investment necessary to bolster the supply chain in the wake of COVID-19.

Europe Policy

Generics Firms Seek To Establish Better Conditions For Post-Approval Change Flexibility

Concerns raised around defining ICH Q12 “established conditions” for post-approval changes and potential role of prior knowledge for legacy products discussed in the context of generic drug applications; likely residual lack of harmonization explored.

Manufacturing Quality

Fresenius Kabi To Build ‘One Of The Largest Sterile Injectable Manufacturing Networks In US’

Stating the importance of the US sterile injectables market for Fresenius Kabi, Matt Kuhn, senior director of external communications, talks to Generics Bulletin about the company’s plans to build one of the largest sterile injectable manufacturing networks in America. Meanwhile Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi in the US, talks about supply reliability in biosimilars. 

Biosimilars Deals

Lannett To Close And Sell NY Liquids Plant As Part Of Restructuring Plans

Lannett is once again taking the axe to its operations in order to tighten its focus and save on costs, including the planned divestment of its liquids generics manufacturing facility in Carmel, New York.

Commercial Companies

Fresenius Kabi Concedes On FDA Pegfilgrastim Chances

Fresenius Kabi is continuing to suffer from the longstanding effects of the US FDA backlog for onsite inspection reviews amid the coronavirus pandemic. Management discussed Kabi’s latest prospects on its proposed pegfilgrastim biosimilar, as well as adalimumab and tocilizumab.

Biosimilars FDA
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