Acetylcysteine

Chronic respiratory diseases have long ranked among the most prevalent diseases worldwide. Airway mucus hypersecretion is a typical pathological feature of such diseases, which significantly increases the risk of acute exacerbation and respiratory failure in patients. Acetylcysteine is a mucolytic expectorant that reduces sputum viscosity by breaking disulfide bonds in mucin molecules. It also has antioxidant and anti-inflammatory effects, which can alleviate the damage of reactive oxygen species to airway epithelium. This drug is indicated for patients with chronic obstructive pulmonary disease, chronic bronchitis, emphysema and other diseases accompanied by thick sputum that is difficult to cough up. It can also be used for the adjuvant treatment of idiopathic pulmonary fibrosis, and as a specific antidote for paracetamol poisoning, covering a wide range of medication populations including adults and children.

The global acetylcysteine market size was approximately USD 1.28 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain around 5.2%. The main driving factors include the rising prevalence of respiratory diseases, the expansion of medication demand among the elderly population, and the expansion of application scenarios in the field of detoxification. For the domestic market, this variety has been included in the National Medical Insurance Catalog and is a commonly used variety of respiratory drugs. Among them, the inhalation solution dosage form has seen a significant volume increase after centralized procurement, and its sales in domestic sample hospitals exceeded RMB 1.7 billion in 2023. The supply of API is dominated by domestic enterprises, and currently more than 30 enterprises have obtained the API production approval for this variety, leading to relatively sufficient market competition.

The original developer of acetylcysteine is Japan's Sanwa Pharmaceutical Co., Ltd., with the original brand name Fluimucil. The core compound patent has expired globally. At present, the domestically approved original dosage forms include granules (100mg, 200mg), tablets (600mg) and acetylcysteine solution for inhalation (3ml:0.3g), all of which have been included in the *Reference Listed Drug Catalog of Chemical Drugs* issued by the National Medical Products Administration. In terms of domestic API registration, as of now, there are more than 60 registration numbers of acetylcysteine on the CDE API registration platform, among which more than 40 registration numbers are in status A (usable in marketed preparations). Domestic preparations of multiple dosage forms such as tablets, granules, inhalation solutions, effervescent tablets 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 acetylcysteine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research, declaration and registration, etc.