Acetazolamide

As a commonly used carbonic anhydrase inhibitor in clinical practice, acetazolamide reduces the reabsorption of bicarbonate and the production of aqueous humor by inhibiting the activity of carbonic anhydrase in renal tubular epithelial cells, ciliary body epithelial cells and other parts, and has the dual pharmacological effects of diuresis and intraocular pressure reduction. In addition to being the basic medication for reducing intraocular pressure in the acute phase of glaucoma in clinical practice, it can also be used for the adjuvant treatment of cardiogenic edema, and is also one of the first-choice drugs for the prevention and relief of acute mountain sickness. It covers multiple diagnosis and treatment scenarios such as ophthalmology, cardiovascular department, and mountain sickness prevention and treatment, and the applicable population includes patients with various types of glaucoma, people working/traveling at high altitudes, and patients with some edema diseases.

The global acetazolamide market size has maintained a stable growth rate of about 3% for a long time, with a market size of about USD 180 million in 2023, of which the Chinese market accounts for about 17%. Due to the long time since the product was launched, the current market is dominated by generic drug supply. The annual output of domestic API has been stable at around 150 tons in the past three years. In addition to meeting the domestic demand for preparation production, about 40% of the output is exported to supply the Southeast Asian, European and American markets. The overall competition pattern is fragmented, and no manufacturer with an absolute leading position has emerged yet.

The original research enterprise of acetazolamide is Teva Pharmaceuticals, and the original trade name is Diamox. The core compound patent in the United States expired in 1988. At present, the main dosage forms of the original research product on the market include 250mg tablets and 500mg injections. The tablets have been included in the FDA Reference Listed Drug Catalog, and the original research product has not been listed as a reference preparation in China for the time being. In terms of domestic API registration, 6 enterprises have obtained CDE registration numbers for acetazolamide APIs, of which 3 are in Class A status and can legally supply domestic preparation production. The corresponding domestic oral preparations and injections have been approved for marketing for many years. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and production quality control needs of acetazolamide, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can be directly used for impurity qualitative and quantitative research, stability investigation and registration declaration related work.