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your ccure api by Lebsa and Selectchemie CAS-RN: 1257044-40-8

by Lebsa & Selectchemie

Venetoclax is a BH3 mimetic used to treat chronic lymphocytic leukemia. It blocks the anti-apoptotic B-cell lymphoma-2 (Bcl-2) protein.

Venetoclax is an integral CCURE solution that comes with a supply chain strategy and strong client support. It offers you a single RoS for all your markets, with four very efficient GMP Chemical steps completed at LEBSA in Barcelona.

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Venetoclax EU figures

  • Trade name VENCLYXTO
  • Annual sales 2019 213 M
  • Annual API
    Kg 2019
    392 Kg
  • FDF IR film-coated Tablet 10, 50 & 100 mg
  • FDF technology Hot Melt Extrusion with copovidone
  • Indications Chronic lymphocytic leukemia
  • Product Patent Expiry 6.12.2031
  • Data Protection 4.12.2024
  • Market Exclusivity 4.12.2026
  • A single

    RoS for all your markets, with four very efficient GMP chemical steps done in Barcelona.

  • Two validated

    suppliers of starting materials in order to reduce costs and risks.

  • 10 to 30

    Kg batch size. Ability to scale-up supplies in-house, if demand increases.

  • Strong

    experienced internal QA, RA, IP and R&D teams to support your needs.

  • Experienced

    in DMF for non-EU countries such USA or Brazil.

One molecule for all markets

Venetoclax offers a single RoS for all your markets, with the guarantee of an EUGMP validated by a large number of multinationals and the main international health authorities.

Our ASMF is customized per country and we have experience registering APIs with the main regulatory bodies (EMA, ANVISA, TGA, PMDA, MIT Russia, Taiwan FDA, China NMPA, Canada Health, etc.)

A logistics strategy to suit your needs

Ask our specialist

Let us cure together

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