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Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning

 
• By Bowman Cox

Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.

Batch versus continuous manufacturing
The future may be continuous -- and then back to batch

The organization that represents generic drug companies in the US has taken a hard line against technological innovation in pharmaceutical manufacturing that unfairly increases the quality of brand drugs.

The Association for Accessible Medicines Nov. 17 warned FDA to "remain vigilant" against brand firms' use of new technologies like...

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More from Manufacturing

Sandoz Strikes $300m Deal With Just-Evotec For French Biosimilars Site

 
• By Dave Wallace

Sandoz has made yet another major move to further bolster its booming biosimilars business, striking a $300m deal to acquire outright a French development and manufacturing facility from existing biosimilars partner Just-Evotec Biologics.

Celltrion Nears Deal For US Biologics Plant To Quell Tariff Concerns

 
• By Dean Rudge

Celltrion is the preferred bidder for the acquisition of a large-scale cGMP biologics manufacturing plant in the US, marking a pivotal move to localize production and secure its US pharmaceutical business against rising tariff risks.

FDA Inspection Finds Leaks and Mold at Sun Pharma Halol Facility

 
• By Dean Rudge

Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.

Cipla CEO On Tariff Threat: ‘We Have One Of The Most Well Diversified Models’

 
• By Anju Ghangurde

Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.

More from Business

Civica Pairs With Fresenius Kabi To Supply Stelara Biosimilar

 
• By Dave Wallace

US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.

Who’s Hired? Rosemont Gains A Chairperson But Loses A CEO

 
• By Dave Wallace

In our latest roundup of off-patent industry appointments, we see management changes at UK liquids specialist Rosemont, a push into biosimilars from Korea’s Daewoong, and fresh appointments at firms including Meitheal, Celltrion, Accord, Alvotech, Civica and Centrient.

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.