Terfenadine

As allergic diseases are chronic diseases with high global incidence, antihistamines are one of the core medications for clinical symptom control. Terfenadine is a second-generation H1 antihistamine, which can selectively block peripheral H1 receptors and inhibit histamine-mediated allergic reactions. It is not easy to cross the blood-brain barrier and has no obvious central sedative effect. Clinically, it is mainly used for the treatment of allergic diseases such as allergic rhinitis, urticaria and hay fever, and is suitable for adult and adolescent allergic patients who need to maintain concentration at work and study. It can effectively relieve uncomfortable symptoms such as nasal itching, sneezing and skin rash.

After its launch, terfenadine once occupied an important share in the antihistamine market due to its low central side effects. At present, its overall market size tends to be stable. Affected by the promotion of newer generation antihistamines, the market growth rate remains in the range of 1% to 3%. The competitive landscape is dominated by generic drugs. Globally, India and China are the main supply regions of this API. Fewer than 10 enterprises have obtained approval for production in China, so the market supply is relatively concentrated. It is not included in the scope of national centralized volume-based procurement, and the supply and demand relationship has remained stable for a long time.

The original research enterprise of terfenadine is Sanofi, with the original brand name Seldane. The core compound patent expired in 1996. The main dosage form of the original research product is tablet, with specifications of 60mg and 120mg, which has been included in the FDA Reference Listed Drug Catalog. At present, terfenadine preparations from multiple domestic enterprises have been approved for marketing. According to the API registration platform, 4 domestic terfenadine APIs have been approved for marketing through the associated review with preparations, and no imported API has been registered in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of terfenadine impurity reference standards. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for enterprises in links such as API quality research and preparation stability investigation.