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About Apremilast (Amorphous & Form B) API

Product
  • Therapeutic Category中枢神经系统 (CNS)

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, Brazil DMF, Canada DMF

作用机制

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.

适应症

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

Dr. Reddy's的专长

Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。

Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 阿普斯特(无定型及晶型B) API是研发,知识产权和监管方面广泛专业知识的结果。

帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。

RFQ Form

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Related Resources

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FAQs

What is the dosage form available for Apremilast API?
  • Available in Tablet dosage form with a strength of 10, 20 and 30 Mg

How do you store Apremilast API?
  • Store below 30°C (86°F).

What are the uses of Apremilast ?
  • Apremilast is used to treat ulcers in the mouth in people with Behcet's syndrome (a disorder that causes blood vessel swelling in the body). Apremilast is in a class of medications called phosphodiesterase inhibitors. It works by blocking the action of certain natural substances in the body that cause inflammation.


     

What is the BCS classification for Apremalist?
  • Due to its low solubility and permeability, it is classified as a class IV drug according to BCS classification.

What is the polymorph form available for Apremalist?
  • We offer Amorphous and crystalline form

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.