Risedronate sodium 2.5-hydrate

Risedronate sodium 2.5-hydrate
Product Description

Risedronate is used to treat osteoporosis caused by menopause, or steroid use. risedronate is for use when you have a high risk of bone fracture due to osteoporosis. Risedronate is also used to treat Paget's disease of bone. Risedronate may also be used for purposes not listed in this medication guide.

Polpharma API

  • Long experience in in-house commercial manufacturing
  • Extensive portfolio of Bisphosphonates
  • Technology not generating genotoxic impurities

  • Polpharma Group

    • Country/Region:
      Poland
    • On CPHI since:
      2015
    • Certificates:
      4
    • Employees:
      5000+
    Company types
    CMO/CDMO
    Contract Service
    Generics/Biosimilars Manufacturer
    Manufacturer/Innovator
    Pharmaceutical company
    Specifications
    • CAS Registry Number
      329003-65-8
    • Details
      Status Commercial


      Therapeutic cat. Musculo-skeletal


      Polymorphic formForm A


      CAS No.329003-65-8


      Injectable Form


      EU DMF readiness


      CEP


      JAPANESE DMF


      KOREAN  DMF


      CANADIAN  DMF


      CADIFA -pending


      US DMF readiness
    • Selling Points
      ✔️ HP API (OEL up to 10 ng/m3)
      ✔️ EU manufacturing site
      ✔️ US FDA-approved
      ✔️ 70 years of experience in small molecules
      ✔️ cGMP manufacturing
      ✔️ Highest quality standards
      ✔️ Research, Development, and Commercial Manufacturing
      ✔️ World-class regulatory support
      ✔️ Smooth and transparent cooperation

    Polpharma Group

    • Country/Region:
      Poland
    • On CPHI since:
      2015
    • Certificates:
      4
    • Employees:
      5000+
    Company types
    CMO/CDMO
    Contract Service
    Generics/Biosimilars Manufacturer
    Manufacturer/Innovator
    Pharmaceutical company

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