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About Apremilast (Amorphous & Form B) API

Product

  • Therapeutic CategoryCentral Nervous System (CNS)

  • CAS Number

    608141-41-9

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    USDMF, Brazil DMF, Canada DMF

Mechanism of Action

Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients and psoriasis patients is not well defined.

Indication

OTEZLA, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of:

  • Adult patients with active psoriatic arthritis
  • Patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

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Related Resources

Dr.Reddy's Apremilast API and finished formulation offerings.

Dr.Reddy's Apremilast API and finished formulation offerings.

Dr. Reddy's is one of the leading API pharma companies supplying Apremilast API globally, and has led the USDMF filing in September 2016 (Form-B) and June 2017 (Amorphous).Apremilast, is an anti-inflammatory agent modulating a wide range of inflammatory mediators in psoriasis and psoriatic arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis and moderate to severe plaque psoriasis.Dr. Reddy's amorphous API has been successfully formulated into drug products by various formulators with successful bioequivalence studies and subsequent dossier filing.To know more about our offerings , please read the technical sheet on Apremilast by filling the contact from below.
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Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.