Bromocriptine

The long-term management demand for chronic diseases such as prolactinoma and Parkinson's disease has driven the continuous expansion of the clinical use scale of therapeutic drugs targeting the dopaminergic pathway. As a semi-synthetic ergot alkaloid dopamine D2 receptor agonist, bromocriptine can inhibit the synthesis and release of prolactin by activating hypothalamic dopamine receptors, and at the same time directly act on pituitary prolactin cells to reduce hormone secretion. Clinically, it is mainly used for the conservative treatment of menstrual disorders, infertility and prolactinoma caused by hyperprolactinemia. It can also be used as a monotherapy option for early-stage Parkinson's disease or a combination therapy option for middle and late-stage Parkinson's disease, and can also help improve the hormone levels of patients with acromegaly, covering long-term medication populations in multiple departments such as endocrinology and neurology.

The current global bromocriptine market size is approximately USD 870 million, with a compound annual growth rate maintained at around 3.2%. The core growth drivers are the increase in the number of Parkinson's disease patients and the improvement of diagnosis and treatment rates in the endocrine field. In terms of the domestic market, the annual sales at the terminal of public medical institutions have exceeded RMB 1.2 billion, and the generic drug substitution rate has reached 61%. After the implementation of the centralized procurement policy, the average price reduction has reached 48%, which further improves the accessibility of medication at the primary level. In the current competitive landscape, local API manufacturers account for more than 70% of the supply share, gradually realizing the substitution of the original research supply.

The original research manufacturer of bromocriptine is Novartis, with the original research brand name "Parlodel/Parlodel CR", and the brand name in the Chinese market is "佰莫亭 (Bromoting)". Its core compound patent expired globally in 1999. The main dosage forms approved for the original research product include conventional tablets (2.5mg), sustained-release tablets (5mg) and injections. Among them, the 2.5mg conventional tablet has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also listed in the FDA Reference Preparation Catalogue. As of now, there are a total of 16 bromocriptine API registration entries on the CDE API Registration Platform, of which 8 have been activated, and bromocriptine tablets from multiple domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO can provide a full set of bromocriptine impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the multi-scenario needs of API manufacturers such as quality research, consistency evaluation and daily release testing, providing stable reference material support for the R&D and production links of enterprises.