Etodolac

Etodolac
Product Description

Therapeutic Area: Musculo-skeletal systemEU DMF availableUS DMF no. 11405 availableJapanese DMF availableCEP available Indication: Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of mild to moderate pain, fever, and inflammation.

Polpharma S.A.

  • PL
  • 2015
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Specifications
  • CAS Registry Number
    41340-25-4
  • Details
    StatusCommercial
    Therapeutic cat.Musculo-skeletal
    Polymorphic form Crystalline racemate, none
    CAS No.41340-25-4


    EU DMF

    CEP
    JAPANESE DMF
    KOREAN  DMF
    CANADIAN DMF
    CADIFA
    US DMF
  • 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
  • Supplied from
    Poland

Polpharma S.A.

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

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  • News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2

    This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? 
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    Thanks to over 70 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up allowing smooth process transfer for commercial-scale manufacturing capabilities, with world-class regulatory support. Our strong R&D management team, experienced in the development of chemical processes and complex projects, provides a wide range of solutions to our customers, applying a variety of chemical reactions and conditions, including cryogenic, High Pressure, strong base reactions, and tailor-made particle size distribution modifications. At Polpharma quality comes first. Regular FDA audits prove our reliability and credibility towards business partners around the world.
  • News KiloLab Laboratory: strategic milestone achieved!

    KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021.
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  • Video Strategic investment HP API facility

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