1. Generics Bulletin
  2. >>Business

Sun is still struggling with faults at Halol

Sun Pharmaceutical Industries is preparing its responses to three ‘Form 483’ observations of deficiencies resulting from a re-inspection of the firm’s key Halol, India, formulations facility by the US Food and Drug Administration (FDA) from 12-23 February.

Sun Pharmaceutical Industries is preparing its responses to three ‘Form 483’ observations of deficiencies resulting from a re-inspection of the firm’s key Halol, India, formulations facility by the US Food and Drug Administration (FDA) from 12-23 February.

Responses to the FDA’s observations would, Sun pledged, be submitted to the agency within 15 business days. The Indian firm...

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

More from Business

Krka Passes €1bn Threshold In Just Six Months

 
• By Dean Rudge

Krka has reported its strongest-ever half-year results, surpassing €1bn in sales and growing EBITDA by 8%. Solid performance across most regions, particularly Eastern and Central Europe, supported stable margins and a positive full-year outlook.

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.