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

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
• By Neena Brizmohun

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

More from Compliance

Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
• By Cathy Kelly

Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 
• By Jessica Merrill

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.