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.

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.

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.

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.

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.

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.

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.”

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.

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.
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