Carteolol

For irreversible blinding eye diseases such as glaucoma, clinical practice has long relied on β-blockers to control intraocular pressure. Carteolol is a second-generation non-selective β-blocker with a clear advantage in corneal penetration. It blocks β-adrenergic receptors in the ciliary processes to reduce aqueous humor production, while not affecting pupil size and regulatory function. Compared with traditional β-blockers, it is less likely to cause adverse reactions such as blurred vision and visual impairment. It is applicable to patients with primary open-angle glaucoma and ocular hypertension, and also serves as an important option for combination therapy of angle-closure glaucoma. It has better tolerance in patients with comorbid asthma and chronic obstructive pulmonary disease, and is one of the basic medications for intraocular pressure lowering treatment in ophthalmology.

The global market size of carteolol-related preparations is approximately USD 230 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the year-on-year increase in the prevalence of glaucoma and the improvement of primary ophthalmology diagnosis and treatment coverage in emerging markets. At present, the original research drug still accounts for nearly 60% of the domestic market share, and 3 enterprises have been approved to produce generic preparations. In the 2022 provincial-level centralized procurement, the average price of carteolol eye drops was reduced by 47%, the substitution space for generic drugs continues to expand, and the demand for upstream API is increasing year by year with the implementation of centralized procurement.

The original research enterprise of carteolol is Otsuka Pharmaceutical of Japan, with the original research trade name "Mikelan". The core compound patents of carteolol in major markets such as Japan and the United States expired around 2008, and the compound patent in China also expired in 2008. The main dosage form approved by the original research is eye drops, with specifications including 1% and 2%. The 2% specification has been included in the China Listed Medicines Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Currently, 2 A-status registration numbers of carteolol API can be queried on the platform of the Center for Drug Evaluation of China. A number of domestic enterprises have been approved to produce carteolol eye drop preparations, with supply covering medical institutions at all levels. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for carteolol API. Most products are in sufficient stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-scenario needs of API R&D, quality research and routine production testing.