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About Apremilast (Amorphous & Form B) API

Product
  • Therapeutic CategoryCentral Nervous System (CNS)

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • 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

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Apremilast (Amorphous & Form B) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Apremilast (Amorphous & Form B) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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.
Apremilast (Amorphous & Form B) API Manufacturer and Supplier | CAS 608141-41-9  - Dr. Reddy's