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Biocon Ltd.

www.biocon.com

Latest From Biocon Ltd.

Keeping Track: FDA Hands Out Complete Responses, Expedited Pathway Designations

The latest US drug development news and highlights from our Performance Tracker.

Performance Tracker Drug Review

CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

Europe Approvals

Will Intas’ Cut-Price Avastin Biosimilar Disrupt The Market?

Intas Pharmaceuticals has introduced its biosimilar bevacizumab in India at less than half the innovator product’s price, putting the spotlight on how its competition might tackle the new entrant’s pricing position.

Commercial Strategy

Celltrion Biosimilar Is Latest To Run Into GMP Compliance Concerns

An FDA inspection uncovered a wide-ranging list of GMP problems at biopharmaceutical manufacturer Celltrion in South Korea. Among some of the problems that inspectors found were mold on walls in sterile areas, operators leaning over sterile areas with bare hands and arms, and employees using shared passwords. A resulting Form 483 report is the latest in a number of recent enforcement actions targeting proposed biosimilar drugs.

Manufacturing Quality
See All

Company Information

  • Industry
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Medical Devices
  • Pharmaceuticals
  • Services
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Asia
      • India
  • Parent & Subsidiaries
  • Biocon Ltd.
  • Senior Management
  • Arun ` Chandavarkar, PhD, CEO
    Siddharth Mittal, CFO
    Ravi Limay, Pres., Mktg.
    Narendra Chirmule, PhD, SVP & Head, R&D
  • Contact Info
  • Biocon Ltd.
    Phone: (91) 80 2808 2808
    20th KM Hosur Rd.
    Electronic City
    Bangalore , 560 100
    India
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