Minoxidil

As a classic topical drug for the treatment of androgenetic alopecia, minoxidil is a potassium channel opener. It was initially used for the treatment of hypertension and was found to have the adverse reaction of hirsutism, and later became a first-line drug in the field of alopecia treatment after dosage form improvement. Its mechanism of action is to dilate local blood vessels of the scalp, improve microcirculation around hair follicles, prolong the anagen phase of hair follicles and shorten the telogen phase, thereby promoting hair growth. It is not only suitable for male patients with androgenetic alopecia, but also the first-choice topical treatment for people with non-scarring alopecia such as female androgenetic alopecia and alopecia areata, and its clinical application has been verified for safety for more than 30 years.

At present, the global market size of minoxidil preparations has exceeded 1.5 billion US dollars, with a compound annual growth rate of more than 8% in the past five years. The growth rate of the Chinese market is significantly higher than the global average, and the domestic market size of minoxidil-related products was nearly 3 billion yuan in 2023. Due to the low technical threshold of topical preparations and the early expiration of core patents, the domestic market presents a pattern where the original research drug coexists with a number of generic drugs, with the market share of generic drugs exceeding 60%. The upstream API supply is mainly concentrated in China and India. With the younger trend of alopecia population and the improvement of consumer awareness, the downstream demand will continue to maintain a stable growth trend.

The original research enterprise of minoxidil is Johnson & Johnson of the United States, and the original research trade name is "Rogaine". The core compound patent expired in 1989. At present, the main dosage forms of the original research drug marketed globally include 2% and 5% topical solutions and 5% foam. These relevant dosage forms have been included in the FDA Reference Listed Drug Catalog, among which the 2% and 5% topical solutions are also included in the *Catalog of Reference Listed Drugs of Chemical Drugs* of China. In terms of domestic API registration, more than 20 enterprises have obtained CDE registration numbers for minoxidil APIs with the status of A, and more than 30 domestic preparations have been approved, covering multiple dosage forms such as solutions, gels and foams. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for minoxidil API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for links such as quality research, registration and declaration, and routine production quality inspection of API and preparation enterprises.