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Manufacturing

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Centrient Hails Milestone For Clean Antibiotic Production

Centrient has celebrated passing a “significant milestone in the clean production of antibiotics” after meeting Predicted No Effect Concentration discharge targets set by the AMR Industry Alliance across its entire oral antibiotics product range.

Manufacturing Supply Chain

Olon Invests In R&D Hub In Italy

Italy’s Olon has announced a €10m investment in a new R&D hub in Rodano, Milan, that the active pharmaceutical ingredient specialist says will help to consolidate its expertise and connect its worldwide network of 11 facilities.

Research & Development Manufacturing

Nichi-Iko Aims To Regroup As It Enters Turnaround Process

Japan’s Nichi-Iko has formally entered a business turnaround alternative dispute resolution process that will see the company outline a business rehabilitation plan involving management restructuring and a fresh profit structure, following financial underperformance in the wake of recent quality issues.

Strategy Sales & Earnings

Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA

Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.

Biosimilars Europe

IFC And Nippon Chemiphar Ally In Asia, Middle East And Africa

Japan’s Nippon Chemiphar and the International Finance Corporation have announced an alliance that will see the pair collaborate to boost local production of generics in Asia, the Middle East and Africa, as part of efforts to reduce reliance on imports.

Deals Manufacturing

Teva: Payers Hold The Cards On Material 2023 Adalimumab Opportunity

Fresh from partner Alvotech resolving patent litigation in the US for its proposed Humira biosimilar, Teva management has detailed the firm’s expectations around the product and the crucial issue of supply.

Biosimilars Reimbursement

Sanofi’s API Business Nears Listing On Euronext Paris

French giant Sanofi is potentially just days away from seeing its standalone Euroapi API business – in which it is set to hold a 30% stake – listed on the Euronext Paris bourse. Euroapi’s management has stressed that it “offering highly differentiated APIs, which require scale in production with efficient processes.”

Ingredients Manufacturing

Lupin Appoints New Compliance Manager As More Deficiencies Found

Lupin has named a new head of compliance, emphasizing the importance of achieving the highest quality standards just weeks after the FDA notified the firm of observations following an inspection at its Indian facility in Tarapur.

Executive Changes Manufacturing

Catalent Invests $350m In Bloomington As Recipharm Ties Up Deals

In the burgeoning biologics CDMO space, Catalent has announced further investment at its flagship campus in Bloomington, Indiana, while Recipharm has wrapped up a pair of deals that will beef up the Sweden-based firm’s presence in the US.

Biologics Manufacturing
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