1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

Will FDA GMP Observations Stall Biocon’s Run?

 
• By Anju Ghangurde

The FDA has flagged up GMP deviations at Biocon’s Bangalore site, though the company asserts that most of these are procedural blips resulting from ‘heightened’ regulatory expectations. The compliance concerns come ahead of the user fee goal date for Biocon and partner Mylan’s biosimilar trastuzumab next month.

SC1610_PillsMagnifyingGlass_1200x675

Biocon Ltd. continues to grapple with GMP challenges – this time an FDA audit has identified 10 deviations at its Bangalore manufacturing site, though the company suggests it is already on course to set things right. The FDA inspection at Biocon’s Bommasandra site in Bangalore was done between May 25 and June 3.

The latest regulatory setback comes in the run up to the anticipated FDA action date for Biocon and partner

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

More from Compliance