Bambuterol

Bronchial asthma is a highly prevalent disease in the field of chronic respiratory diseases. Patients require long-term regular medication to control airway spasm symptoms, and long-acting β₂ receptor agonists are first-line control medications recommended by guidelines. Bambuterol is a selective β₂ adrenergic receptor agonist and a prodrug of terbutaline. After oral administration, it is slowly hydrolyzed by cholinesterase in vivo to release the active ingredient terbutaline, which can selectively relax bronchial smooth muscle, inhibit the release of endogenous spasmogenic substances and reduce airway mucosal edema. Only once-daily administration is needed to maintain a 24-hour anti-asthmatic effect. It is clinically mainly used for the treatment of bronchial asthma, chronic asthmatic bronchitis, obstructive emphysema and other pulmonary diseases accompanied by bronchospasm. The applicable population covers adults and pediatric asthma patients over 5 years old, and its medication compliance is significantly better than that of short-acting β₂ receptor agonists.

The global market size of bambuterol preparations has maintained a compound growth rate of 3.2% in the past five years, with a market size of approximately USD 1.28 billion in 2023, of which the Chinese market accounts for approximately 17%, with a growth rate of 4.7% higher than the global average. At present, the domestic market competition is dominated by generic drugs, with the market share of original research products being less than 20%. 11 local enterprises have obtained the approval documents for oral preparations. After the volume-based procurement, the terminal price of preparations has dropped by more than 60%, driving the continuous expansion of demand for upstream API. The domestic API supply is dominated by local enterprises, and no imported API has been registered for marketing in China.

The original research enterprise of bambuterol is AstraZeneca, with the original trade name "Bambec". The core compound patent expired globally in 2003. The dosage forms of the original research approved in China include bambuterol hydrochloride tablets (10mg, 20mg) and bambuterol hydrochloride oral solution (10ml:10mg, 100ml:0.1g). Both dosage forms have been included in the China Listed Drug Catalogue as reference preparations. In terms of API registration, as of now, there are 9 registration numbers for bambuterol hydrochloride API in China, 7 of which are in status A and can be used in association with domestic preparation declarations. All domestic bambuterol preparations have achieved localized supply. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full range of bambuterol impurity reference standards, which meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock regularly, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard needs of API enterprises in the whole process of process R&D, quality research and consistency evaluation.