Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: EU-Poland

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Sample Provided: yes

    Payment Terms: L/C

    Apremilast

    Status Pipeline
    Therapeutic cat. Musculo-skeletal
    Polymorphic form Form B
    CAS No. 608141-41-9
    EU DMF readiness Checkbox
    CANADIAN  DMF Checkbox
    US DMF readiness Checkbox

    Drug description

    Apremilast (Otezla) is used to treat plaque psoriasis, psoriatic arthritis, and Behçet's disease in specific patients. Apremilast tablets help improve plaque psoriasis for clearer skin and reduce inflammation and symptoms such as pain, redness, and swelling in psoriatic arthritis and Behcet's disease. Apremilast is a PDE4 inhibitor that works by increasing the level of cAMP (cyclic adenosine monophosphate), a messenger involved in cell signaling in our bodies. Apremilast is not a biologic agent. Apremilast, under the brand name Otezla, received FDA approval on March 21, 2014, for psoriatic arthritis. Since then, it has also been FDA-approved to treat types of plaque psoriasis and Behcet’s disease in specific patients. It is not available as a generic medicine.

     

    Disclaimer: Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Dapagliflozin (amorphous), Linagliptin, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulationare met.

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