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Biocon Ltd.

www.biocon.com

Latest From Biocon Ltd.

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

Biocon’s Oral Insulin Gains Momentum With JDRF Backing

Biocon’s oral insulin program has received a boost with the US-based JDRF supporting plans to progress its drug candidate in type 1 diabetes. While the pullback of players like Novo Nordisk underscores the potential risks in the oral insulin space, JDRF says early results of Biocon’s candidate “warrant support” for further studies.

Metabolic Disorders Deals

More Questions As Biocon Pulls EU Filings For Two Biosimilars

Biocon and partner Mylan have withdrawn the European application for their biosimilar trastuzumab and pegfilgrastim in the backdrop of compliance blips at Biocon’s Indian site, raising critical questions on how soon things can be set right in an increasingly competitive scenario.

Biosimilars Manufacturing

Will FDA GMP Observations Stall Biocon’s Run?

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.

Manufacturing Quality
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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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