Latest Pharmaceutical Manufacturing News

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

Epsilon Healthcare Limited has unveiled a comprehensive pre-reinstatement disclosure, highlighting improved financial health and a strategic growth plan focused on operational stability and expansion.

Epsilon Healthcare reported a 19% revenue increase to $3.4 million for the half year ended June 2025, driven by new client wins and its pharmacy segment launch. However, net losses widened 44% to $2.07 million, reflecting administration and financing costs during its recovery phase.

Bioxyne Limited has secured a pioneering manufacturing and supply agreement to enter the emerging medicinal cannabis markets of Costa Rica and Panama, positioning itself as a first mover with promising revenue potential.

The Takeovers Panel has declared unacceptable circumstances in the Mayne Pharma acquisition after Cosette Pharmaceuticals changed its intentions to close the Salisbury manufacturing site, raising concerns over market transparency and regulatory approval.

The Takeovers Panel has declared unacceptable circumstances in the Mayne Pharma acquisition, ordering Cosette Pharmaceuticals to comply with conditions preventing closure of the Salisbury manufacturing site. This ruling highlights concerns over market transparency and the integrity of the takeover process.

Antaria has disclosed several FDA-identified GMP compliance issues but assures no impact on product quality or supply, committing to expert-led remediation and enhanced training.

Bioxyne Limited is expanding its footprint with a new UK GMP-certified medicinal cannabis manufacturing site, backed by £850,000 in funding from South of Scotland Enterprise. This move positions the company to tap into the UK’s growing medicinal cannabis market, the second largest in Europe.

Epsilon Healthcare reports a strong rebound with a 73% revenue increase in the June quarter, driven by contract manufacturing and new pharmacy operations. The company is emerging from restructuring with renewed financial strength and growth prospects.

Bioxyne Limited, through its subsidiary Breathe Life Sciences, has inked an exclusive deal to import, manufacture, and distribute Curaleaf’s Que Medical Inhalation Device in Australia, with a nationwide launch set for November 2025.

Argent BioPharma has secured a transformative acquisition of AusCann’s core assets, bolstering its drug delivery technology and manufacturing capabilities ahead of a planned U.S. listing. The company also reported key clinical milestones and refinancing moves in its September 2025 quarterly update.