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Manufacturing Round-Up: FDA Demands Meeting With Aurobindo Over Issues At Multiple Sites

 
• By Aidan Fry

An FDA warning letter issued to Aurobindo highlights recurring failures over several sites, while Teva is setting up a biologics development campus in the US and Nexus is investing in sterile injectables capacity.

Work station
Compliance problems continue to haunt Aurobindo's API facilities • Source: Shutterstock

Aurobindo Pharma has been told to schedule a regulatory meeting with the US Food and Drug Administration to discuss current good manufacturing practice compliance problems at three of its bulk drugs facilities.

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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.

Biocon Biologics Teams Up With Civica On US Insulin Production

 
• By Dave Wallace

Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.

More from Business

Aurobindo Plots Rivaroxaban Roll-Out As FDA Approves 2.5mg Strength ANDA

 
• By Dean Rudge

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By Dave Wallace

Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.

Wockhardt Confirms US Market Exit After Past Challenges

 
• By Adam Zamecnik

Following past challenges on the US market, the Indian pharma player Wockhardt will be shuttering its presence in the country due to commercial reasons.