Roflumilast Suppliers & Bulk Manufacturers

Available Forms: Tablet / Cream

Available Strengths: 250 mcg, 500 mcg, 0.05%, 0.15%, 0.3%

Reference Brands: Daliresp (USA), Zoryve (USA)

Category: Respiratory Disorder

Roflumilast is a selective phosphodiesterase-4 (PDE4) inhibitor used for the treatment of severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis to reduce the risk of exacerbations. It works by reducing inflammation in the lungs, improving airflow, and decreasing the frequency of COPD flare-ups.

Product Description:

Roflumilast is a selective phosphodiesterase-4 inhibitor, and it is unusual in this category for having two entirely separate clinical lives. Orally at 250 and 500 mcg it is indicated in severe COPD with chronic bronchitis and a history of exacerbations, reducing exacerbation frequency through anti-inflammatory action rather than bronchodilation — it produces no immediate symptomatic relief, which patients must understand or they will stop taking it. Topically at 0.05%, 0.15% and 0.3% it treats plaque psoriasis and seborrhoeic dermatitis.

The oral product's limitation is tolerability. Diarrhoea, nausea and weight loss are common and frequently cause discontinuation; psychiatric effects including mood change have been reported and warrant caution in patients with a history of depression.

Sourcing notes. The oral and topical products share a molecule and nothing else. They are separate registrations, separate manufacturing capabilities and separate buyers — a dermatology distributor and a respiratory distributor are not the same customer. Establish which is required before quoting; a specification giving only "roflumilast" with a percentage strength is a topical product, while one giving micrograms is oral. The topical formulations are more recent and their patent position is narrower geographically than the oral product's, so verify freedom to operate for the specific presentation.