Difamilast API - A Topical PDE4 Inhibitor for Atopic Dermatitis Treatment.

Difamilast (CAS: 2274533-11-9) is a high-purity active pharmaceutical ingredient (API) that functions as a selective phosphodiesterase 4 inhibitor. Specifically developed for the treatment of atopic dermatitis and inflammatory skin conditions, it offers targeted anti-inflammatory action with favorable safety profile. Manufactured by Hefei TianRui Pharmaceutical under strict cGMP conditions, our Difamilast API guarantees high purity, excellent stability, and reliable quality for topical dermatological formulations.

Company Profile

• Founded: 2014

• Focus: High-tech enterprise specializing in the development and industrialization of small-molecule pharmaceutical synthesis technology

• Facilities:

  • Two workshops (TR1 & TR2) with total capacity ≈ 1000 tons/year

  • Reactors: 3000L×15, 2000L×10, and numerous smaller reactors (1000L, 500L, 100L)

  • Ultra-low temperature cryogenic reactor (explosion-proof workshop included)

  • GMP workshop & clean room

• QC Lab Equipment: GC×2, HPLC×3, UV, IR, KF titrator, etc.

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In 2015, the company developed polypeptide absorbent permeation enhancers: ethyl 8-bromo-octanoate and Carsalam, which is the 1st and only qualified Chinese supplier of Semaglutide to meet the internal control requirements of innovator Novo Nordisk.

In 2020, the company independently developed and optimized 8-bromo-octanoic acid and 6-bromo-caproic acid to become a COVID-19 vaccine carrier manufacturer and supplier to Moderna company, contributing its share to the fight against COVID-19.

In 2022, Tianrui R&D Center and cGMP manufacturing facility was inaugurated and put into operation. And in the same year, polypeptide absorbent permeation enhancers SNAC (Salcaprozate Sodium) has successfully obtained the domestic CDE registration number (F20220000072) and the US FDA registration number (037135), and another batch of innovative APIs and pharmaceutical excipients are under registration and approval.