Salmeterol

In the long-term management of chronic airway diseases, long-acting β₂-receptor agonists are a core category of medications for controlling symptoms and reducing the risk of acute exacerbations. As the first long-acting β₂-adrenoceptor agonist, salmeterol can selectively act on the β₂-receptors of airway smooth muscle, producing a bronchodilatory effect lasting more than 12 hours. Meanwhile, it can inhibit the release of inflammatory mediators from mast cells, eosinophils and other cells. It is often used in combination with glucocorticoids for the long-term maintenance treatment of asthma in adults and children, and can also be used for symptom relief in patients with chronic obstructive pulmonary disease (COPD). It is a first-line control medication component explicitly recommended by the Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

The global market size of salmeterol-related preparations is stably above 6 billion US dollars, among which the annual growth rate of the Chinese market remains at around 7%. The demand mainly comes from the improvement of medication coverage for primary-level COPD patients and the standardized promotion of long-term management of childhood asthma. In the competitive landscape, the original research preparations still account for nearly 60% of the market share. With the expiration of core patents, the number of domestic generic preparation applications has increased year by year. At present, salmeterol xinafoate and fluticasone propionate inhalation preparations from 8 enterprises have been approved for marketing. After the volume-based procurement, the price of related preparations has dropped by more than 60%, which directly drives the continuous expansion of upstream API demand. Currently, the annual domestic demand for salmeterol API has exceeded 10 tons.

The original research enterprise of salmeterol is GlaxoSmithKline (GSK), with the original trade name "Serevent". The compound preparation composed of salmeterol and fluticasone has the trade name "Seretide". Its core compound patent first expired in Europe in 2010, the compound patent for the US market expired in 2013, and the compound patent within the territory of China has expired and become invalid. The main dosage forms approved by the original research include inhaled aerosol and inhaled powder for inhalation. The specification of the single-agent formulation is 25 μg per actuation, and most compound preparations are 25 μg salmeterol combined with different doses of fluticasone propionate. The relevant original research dosage forms have been included in the Chinese Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. Up to now, salmeterol APIs from 7 enterprises in China have obtained CDE registration numbers, among which 5 registration statuses are A (already used in marketed preparations), and another 12 salmeterol-containing preparation products have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of salmeterol impurity reference standards, covering the entire research chain including starting materials, intermediates, and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the needs of different scenarios such as registration and declaration, quality research, and release testing. All products comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, helping enterprises efficiently advance the R&D and production processes.