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Amphastar Pharmaceuticals, Inc.

http://www.amphastar.com

Latest From Amphastar Pharmaceuticals, Inc.

Three Gene Therapies, Moderna Metabolic Drug In Inaugural START Class; CBER Oversubscribes

Seven rare disease programs make up the first round of participants in the US FDA’s ‘Operation Warp Speed’-style program. Sponsors will benefit from ‘rapid, ad hoc’ communication with the agency.

Gene Therapy Rare Diseases

Amphastar Plans To Launch Second OTC Product Also In Emergency Medicine Category

Amphastar plans in 2024 to submit application to FDA to move its Rextovy 4mg naloxone hydrochloride intranasal formulation from Rx to OTC. Advertising to drive Primatene Mist awareness planned.

OTC Drugs Prescription To OTC Switch

Amphastar Boosted By Baqsimi And Shortages

The American pharma reported first quarter results that highlighted the ongoing impact of shortages affecting Amphastar’s competitors, alongside the first sales of Baqsimi.

United States Biosimilars

US FDA's Delay In Acting On Moderna RSV Vaccine Adds To Growing List of User Fee Goal Misses

Administrative constraints adds Moderna’s mRNA-1345 to the recently increasing number of US FDA user fee goal date misses.

Review Pathway Vaccines
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
    • Generic Drugs
    • OTC, Consumer
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Nasal
      • Pulmonary
  • Other Names / Subsidiaries
    • Amphastar France Pharmaceuticals (AFP)
    • Armstrong Pharmaceuticals, Inc.
    • International Medication Systems (IMS)
    • Nanjing Puyan Pharmaceutical Technology (ANP)
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