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Three EU Biosimilar Approvals In Five Months? Aurobindo Thinks So

Aurobindo’s CuraTeQ Biologics Arm Bags Key EU Manufacturing Certification

 
• By Dean Rudge

Aurobindo is looking to finally put a key manufacturing disruption behind it in Europe, enabling the firm to gain traction for some of its early biosimilar filings.

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Aurobindo’s India-based biopharma subsidiary CuraTeQ Biologics has marked a “significant milestone” after receiving a good manufacturing certificate of compliance from the European Medicines Agency for its biosimilars manufacturing facility in Hyderabad.

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Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
• By Dave Wallace

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

Sandoz And Delpharm Renew Canadian Injectables Supply Agreement For 10 Years

 
• By Dean Rudge

Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.

More from Generics Bulletin

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Who’s Hired? Botox Biosimilar Developer Aeon Takes CEO From Rival Revance

 
• By Dave Wallace

Aeon Biopharma has picked up Revance Therapeutics executive Rob Bancroft to serve as its new CEO as it continues to pursue a biosimilar version of Botox. Meanwhile, Coherus has lost its chief commercial officer, as Viatris, Sandoz and Medicines for Ireland have announced new appointments.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.