Caffeine

Central nervous system stimulant drugs are an important category for clinical symptomatic treatment of somnolence, refreshing and anti-fatigue. Among them, caffeine, as a methylxanthine derivative, reversibly blocks adenosine receptors to reduce the adenosine-mediated nerve inhibitory effect, and at the same time enhances the release of catecholamine neurotransmitters, so as to achieve the effects of improving alertness, relieving fatigue and relaxing bronchial smooth muscle. In clinical practice, in addition to the treatment of narcolepsy and central inhibition caused by acute alcohol intoxication, it is often used as a compatible component of compound cold medicines and analgesic drugs, and is also the core functional additive in the food field such as energy drinks. It is applicable to patients with central inhibition and the general population who need to improve attention in a short period of time, and has very wide application scenarios in clinical and consumer ends.

The global caffeine market size was approximately USD 2.68 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 4.3%. The production side presents a highly concentrated pattern. China is the world's largest caffeine producer and exporter, with domestic production capacity accounting for more than 80% of the world's total production capacity. The product supply of leading manufacturers covers the global mainstream pharmaceutical and food markets, the industry competition pattern is stable, and leading enterprises have outstanding cost and technical advantages. Affected by the volume-based procurement policy, the supply price of the domestic pharmaceutical-grade caffeine market has remained stable in recent years, and the cost control demand of downstream preparation enterprises has gradually increased.

Caffeine was originally developed by a number of enterprises in the early stage. Among the commonly used clinical preparations at present, the caffeine citrate injection with the original research trade name Cafcit was developed by Mead Johnson, and its core patent expired in 2016. Commonly used dosage forms include injection (20mg/ml) and tablets (100mg, 200mg), and relevant dosage forms have been included in the FDA Reference Listed Drug Catalog. According to the domestic API registration platform, more than 10 enterprises have obtained A-status registration numbers for caffeine APIs, which can meet the needs of domestic preparation production associated review. At the same time, a number of caffeine single and compound preparations have been approved for marketing, among which common compound preparations such as compound paracetamol and amantadine hydrochloride and aminopyrine and caffeine have been included in the medical insurance catalog. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of caffeine impurity reference standards, covering all path impurities in the synthesis process and degradation process. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the quality research and registration declaration needs of API manufacturers and preparation R&D institutions.

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