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Manufacturing

Set Alert for Manufacturing

Olon Expands On Multiple Fronts

Italian API and CDMO specialist Olon is expanding its high-potency capabilities at a site in India, at the same time as unveiling plans to invest a further €30m in a domestic biotech hub.

Manufacturing Ingredients

Civica’s $27.8m New Facility Expands Virginia Drug Hub Vision

Civica has announced a further $27.8m investment to support its plans for insulin and other essential medicines. The news comes shortly after CivicaScript announced its first launch in the form of abiraterone tablets.

Manufacturing Approvals

New CEO Plans ‘Transformation’ For Jubilant Generics

Jubilant Pharmova is planning to transform its generics business with the appointment of a new managing director and CEO, after a difficult period for the unit that saw a tough Q1 amid ongoing difficulties linked to an import alert for its Roorkee manufacturing plant.

Executive Changes Leadership

Earnings Recovery For Nichi-Iko Unlikely Before Full Resumption Of Toyama Shipments

Nichi-Iko still has a long road to recovery ahead as it attempts to get its Toyama plant back on its feet.

Sales & Earnings Strategy

Strides’ Stelis Wins FDA Approval For Bengalaru Injectables Facility

Stelis BioPharma’s flagship Indian manufacturing facility has been cleared under an FDA Establishment Inspection Report.

India Biosimilars

Alvotech Bullish As Facility Deficiencies Hold Up Humira Biosimilar Again

Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.

Biosimilars Complete Response Letters

Biocon Gets FDA Observations At Key Biosimilars Facilities

Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.

Manufacturing Compliance

Zydus To Slice Into Shrinking Revlimid Pie ‘In Near Term’ As Asacol Revenues Erode

Zydus is set to join Natco in chipping away at BMS’ blockbuster Revlimid with its generic version, probably from Q2 while Aurobindo expects to launch by FY24. Revenues from this drug are expected to offset erosion of generic Asacol revenues even as Zydus expects volume growth and new launches to help grow its US business.

Strategy Generic Drugs

Sandoz: US Oral Solids And Injectables Have Reached Bottom

Following Novartis’ announcement that it intended to spin-off its Sandoz business into a standalone company, management from both firms commented on several key issues facing Sandoz, including the US pricing and environment and arrangements for manufacturing.

Generic Drugs Pricing Debate
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