1. Generics Bulletin
  2. >>Business
  3. >>Manufacturing

Are Jubilant Pharmova’s US Plant Closure, FDA Observations At Canada Unit A Concern?

Lupin Continues Good Run With Agency

 
• By Vibha Ravi

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

Ups And Downs For Companies
US FDA's Inspections Have Long Impacted Indian Companies' Earnings • Source: Shutterstock

The US Food and Drug Administration (FDA) has had a significant influence on the direction Indian pharma companies’ revenues could head in a financial year given the dependence of these companies on North America and the role played by the agency as the geography’s gatekeeper.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

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

Samsung Bioepis Reevaluating Approach To Biosimilars

 
• By Jessica Merrill

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.

Polpharma Looks To Supercharge Biosimilar Development With Help Of Chime

 
• By Dean Rudge

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

Fresenius Divests Brazilian Sites To EMS Amid Structural Streamlining

 
• By Adam Zamecnik

The divestment marks a further step in Fresenius’ ongoing strategy towards a more optimized and simplified company structure while doubling down on new endeavors in the Biopharma space.