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Alkem Laboratories Ltd.

www.alkemlabs.com

Latest From Alkem Laboratories Ltd.

The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

Manufacturing Quality

Indian Pharma Regaining Form, Helped By Easing US Price Pressures

Indian drug makers are looking in much better shape as US pricing pressures ease and the domestic market regains its double-digit growth, analysts say.

India Commercial

Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
India Policy

Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India

Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.

Policy & Regulation Clinical Trials
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Asia
      • India
  • Parent & Subsidiaries
  • Alkem Laboratories Ltd.
  • Senior Management
  • Basudeo Narain Singh, Managing Dir.
  • Contact Info
  • Alkem Laboratories Ltd.
    Phone: 22 3982 99 99
    Devashish, Alkem House, Senapati Bapat
    Lower Parel
    Mumbai, 400 013
    India
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