Glycopyrronium Bromide

In the treatment of diseases such as chronic obstructive pulmonary disease (COPD) and peptic ulcer, anticholinergic drugs are among the core medications for relieving symptoms and reducing the risk of acute attacks, and glycopyrronium bromide is a representative variety of such drugs. As a quaternary ammonium antimuscarinic drug, it can competitively block the binding of acetylcholine to M receptors on smooth muscle, inhibit gland secretion, and relax gastrointestinal and airway smooth muscles. Oral preparations are mostly used to relieve spasm and excessive gastric acid symptoms caused by gastric and duodenal ulcers, while inhaled dosage forms are used for long-term maintenance treatment of COPD. It is also used in some preoperative anesthesia scenarios to reduce respiratory tract secretions, and the applicable population covers patients in multiple departments including gastroenterology, respiratory and anesthesiology.

The global market size of glycopyrronium bromide has maintained steady growth in recent years, with the overall size exceeding US$800 million in 2023. Among them, due to the continuous rise in the prevalence of COPD, the compound annual growth rate of inhaled dosage forms reaches 7.2%. In terms of the domestic market, inhaled glycopyrronium bromide was included in the seventh batch of nationally organized drug centralized procurement. The winning bid price has dropped by more than 80% compared with the original research drug, and the clinical accessibility has been greatly improved. At present, the domestic generic drug layout is concentrated in the field of inhaled preparations. The supply of API has long relied on imports in the past, and in recent years, local enterprises have gradually completed registration, and the domestic substitution space is considerable.

The original research enterprise of glycopyrronium bromide is Boehringer Ingelheim, and the trade name of its original research inhaled dosage form is "Spiolto Respimat". The core compound patent of it expired in 2021. The main dosage forms approved for the original research drug include inhaled aerosols, injections and oral tablets. Among them, the specification of inhaled glycopyrronium bromide aerosol is 2.5μg per actuation, which has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. Up to now, more than 10 enterprises have completed A-status registration of glycopyrronium bromide API on the CDE API registration platform, and multiple preparation varieties such as inhaled glycopyrronium bromide solution and glycopyrronium bromide injection have been approved for marketing 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 impurity reference standards for glycopyrronium bromide. Most of the products are available from stock. In-stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide reliable reference material support for API and preparation enterprises in links such as quality research, stability study and registration declaration.