Vardenafil hydrochloride

Vardenafil hydrochloride
Product Description

Vardenafil is an oral therapy for erectile dysfunction that selectively inhibits cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). During sexual stimulation, nitric oxide (NO) is released from nerve endings and endothelial cells in the corpus cavernosum, which activates guanylate cyclase and increases cGMP synthesis in the smooth muscle cells. PDE5 inhibitors like vardenafil prevent the degradation of cGMP, enhancing blood flow into the penis and resulting in an erection. Vardenafil is more potent than sildenafil and tadalafil in inhibiting PDE5, but it has lower selectivity for other PDE isoforms compared to tadalafil.

Polpharma API

  • Long experience in commercial manufacturing
  • Extensive portfolio of PDE-5 inhibitors (Sildenafil, Tadalafil)
  • Wide regulatory documentation
  • 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
      330808-88-3
    • Details
      Status Commercial



      Therapeutic cat. Erectile


      Polymorphic form Trihydrate form


      CAS No.330808-88-3


      EU DMF readiness


      CEP


      CHINESE  DMF


      JAPANESE DMF


      KOREAN  DMF


      CANADIAN  DMF


      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 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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    Polpharma S.A. resources (5)

    • 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? 
    • Brochure API Product List 2025

      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.
    • Brochure Polpharma API CDMO offer

      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.
      We have secured future capacity expansion through both internal enhancements and external partnerships, with the goal of doubling our production capacity.

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