Description

Roflumilast

Roflumilast is a high-purity, selective phosphodiesterase-4 (PDE4) inhibitor used in pharmaceutical formulations for the management of chronic obstructive pulmonary disease (COPD) and related inflammatory respiratory conditions. By increasing intracellular cyclic AMP levels, it reduces inflammation, airway remodeling, and exacerbations associated with COPD. Roflumilast
• Is a pharmaceutical-grade PDE4 inhibitor for oral administration
• Is used in tablets and oral formulations for chronic obstructive pulmonary disease management
• Reduces airway inflammation, remodeling, and frequency of exacerbations
• Is suitable for long-term maintenance therapy in adult patients
• Is manufactured under Good Manufacturing Practice (GMP) certified conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis CoA) and technical data
Roflumilast is chemically designated as 3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide. It appears as a white to off-white crystalline powder that is soluble in organic solvents and formulated into solid oral dosage forms for consistent dosing and bioavailability.
In pharmaceutical applications, Roflumilast is used in:
• Oral tablets for long-term management of COPD and chronic bronchitis
• Combination therapies with bronchodilators, corticosteroids, or other respiratory agents
• Clinical trials for inflammatory airway diseases and research studies
• Compounded oral formulations requiring precise dosing and stability
• Development of controlled-release or fixed-dose combination products
Roflumilast acts by selectively inhibiting PDE4, preventing the breakdown of cyclic AMP in inflammatory cells. This mechanism results in reduced release of pro-inflammatory cytokines and mediators, improving lung function and patient outcomes.
CarboMer supplies Roflumilast with control over assay, polymorphic form, residual solvents, and microbial content. The material is suitable for regulated pharmaceutical development and oral dosage formulation.
The material is packaged in sealed, moisture-resistant, tamper-evident containers. Available in laboratory, pilot, and commercial-scale quantities. Minimum order quantities (MOQ), lead times, and documentation including CoA and SDS are provided upon request.
Each batch is tested for identity (IR, HPLC), assay, residual solvents, water content, heavy metals, and microbial purity. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.
As with all CarboMer respiratory APIs, Roflumilast is supported by formulation guidance, regulatory expertise, and a secure global supply chain to ensure safe, effective, and compliant pharmaceutical products.