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Serum Institute of India Ltd.

www.seruminstitute.com

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Teva 'Pay-For-Delay Case Will Keep Courts Busy For Years'

Once again the European Commission has the marketing practices of the pharmaceutical industry in its sights, with Teva the latest company in the spotlight for an alleged 'pay-for-delay' agreement over the sleep disorder drug modafinil.

Legal Issues Generic Drugs

Insulin Market Competition: Payers Watching FDA 'Transition' Policy

FDA policies around the upcoming regulatory reclassification of insulins as biologics may impact payers' ability to leverage competition and pricing in the market, Express Scripts suggests.

Biosimilars Generic Drugs

FDA Cites Lupin For Poor Quality Metric Performance

Indian firm's invalidated out-of-specification rate was too high, FDA suggests in heavily redacted Form 483 report. This rate, which also came up in two recent warning letters, happens to be one of the three rates the USagency wants to use as quality metrics for deciding how soon investigators should revisit sites.

Compliance Manufacturing

Reference Product Sample Abuses: Indian Firms Flag Concerns With FTC

Indian generic firms appear to be weighing in on controversy around brand name company tactics in the US to block access to reference products for bioequivalence testing – but generic firms may ultimately need legislation to resolve their concerns.

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Company Information

  • Industry
  • Pharmaceuticals
    • Vaccines
  • Therapeutic Areas
  • Infectious & Viral Diseases
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Asia
      • India
  • Parent & Subsidiaries
  • Serum Institute of India Ltd.
  • Senior Management
  • Adar C Poonawalla, CEO
  • Contact Info
  • Serum Institute of India Ltd.
    Phone: (91) 202 699 3900
    212/2, Hadapsar, Off Soli Poonawalla Rd.
    Pune, 411028
    India
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