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Strides Pharma Inc.

Division of Strides Shasun Ltd./Strides Pharma Inc.
www.stridesarco.com

Latest From Strides Pharma Inc.

Regulators Seek Solutions To Manufacturing Woes

Over the past few years, frustrating instances of shortages and recalls – particularly generics – have been blamed on inferior quality control at countless suppliers of active pharmaceutical ingredients and finished products, especially those based in India and China.

Manufacturing Market Intelligence

US FDA Warning Letter Hits Strides On Data Integrity

Even after the US FDA warns Strides on uncontrolled records destruction and poor OOS investigations at its Puducherry plant, firm remains confident in its US market growth projections.

Enforcement Manufacturing

Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch

Just days after Piramal was one of three generic drug sponsors found not to have infringed a Sensipar formulation patent, FDA approved company’s ANDA, threatening Amgen’s de facto exclusivity on the blockbuster calcium-sensing receptor agonist.

Generic Drugs Intellectual Property

Amgen’s Challenge Over Sensipar Pediatric Exclusivity Moves To US Appeals Court

Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.

Legal Issues Intellectual Property
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • OTC, Consumer
  • Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Infectious & Viral Diseases
  • Metabolic Disorders
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Strides Shasun Ltd.
  • Senior Management
  • Contact Info
  • Strides Pharma Inc.
    Phone: (609) 773-5000
    2 Tower Center Blvd.
    Suite 1102
    East Brunswick, NJ 08816
    USA
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