Aripiprazole

Aripiprazole
Product Description

Therapeutic Area: Nervous SystemEU DMF availableUS DMF no. 23314 availableCEP available Indication: used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adults. Aripirazole is also used to treat irritability and symptoms of aggression, mood swings, temper tantrums, and self-injury related to autistic disorder in children who are at least 6 years old.

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
    129722-12-9
  • Details
    Aripiprazole is an antipsychotic medicine that is used to treat schizophrenia in adults and children at least 13 years old. Aripiprazole is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury). Aripiprazole is used alone or with a mood stabilizer medicine to treat bipolar I disorder (manic depression) in adults and children at least 10 years old. Aripiprazole is used with antidepressant medication to treat major depressive disorder in adults.

    Polpharma API
  • Long experience in in-house commercial manufacturing
  • 2 production lines
  • Injection grade anhydrous API

  • 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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      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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      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.
    • Video Strategic investment HP API facility

      As an EU-based Contract Development and Manufacturing Organization (CDMO) and supplier of active pharmaceutical ingredients, we are advancing our technology capabilities with an Occupational Exposure Limit (OEL) as low as 10 ng/m³ (OEB 6).
      Our new capabilities enable GMP and FDA-approved kilo-scale production, offering batch sizes of up to 1.5 kg. This facility features dedicated Analytical Development Laboratories (ADL) and Process Development Laboratories (PDL) to ensure comprehensive support for all production phases. The design incorporates state-of-the-art isolator technology to ensure the safety of both personnel and products, along with industry-standard secondary containment solutions integrated into the infrastructure.
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