Acetaminophen

Fever is one of the most common clinical symptoms worldwide, and the clinical demand for antipyretic and analgesic drugs has always been at the core of essential medications. Paracetamol (acetaminophen) is an aniline-class antipyretic and analgesic, which exerts antipyretic and analgesic effects by inhibiting the synthesis of prostaglandins in the central nervous system. It has weak anti-inflammatory effects, and its gastrointestinal irritation is significantly lower than that of non-steroidal anti-inflammatory drugs. It is the preferred antipyretic and analgesic drug for children, the elderly and people with gastrointestinal sensitivity. Meanwhile, it is also widely used for the relief of mild to moderate pain such as headache, arthralgia and neuralgia. Its clinical application scenarios cover common cold, influenza, postoperative analgesia and other fields, and it is one of the most widely used OTC drugs in the world.

As the antipyretic and analgesic API with the largest global consumption, the total annual output of paracetamol exceeds 150,000 tons. China is the largest producer and exporter in the world, with its production capacity accounting for more than 80% of the global total. In 2023, the global paracetamol market size was approximately USD 1.08 billion, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 2.8%. The demand growth mainly comes from the expansion of primary care market, the popularization of OTC channels and the wide application of compound preparations. The competition pattern of the domestic market is highly concentrated, with the production capacity of leading enterprises accounting for more than 60%. Driven by the centralized procurement policy, the price of preparations tends to be stable, and the compliance and stability of API supply have become the core procurement considerations for downstream enterprises.

The original research enterprise of paracetamol is McNeil Company of the United States, and the original brand name is Tylenol. The core compound patent expired in 1955. At present, the main dosage forms of the original research products on the market include tablets, sustained-release tablets, oral solutions, suppositories, etc., and the conventional specifications cover 0.3g, 0.5g, 100ml:3.2g, etc. The original research preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs for Chemical Drugs* of China. Up to now, there are more than 120 paracetamol API registration numbers on the domestic API registration platform, among which more than 80 are in A status, and there are more than 2,000 domestic preparation approvals, with a mature supply system.(Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of paracetamol impurity reference standards. Most products 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 provide stable and reliable reference substance support for API production, preparation R&D and quality research links.

CATO/佳途科技可提供对乙酰氨基酚全套杂质标准品,大部分产品现货供应,现货产品16:00前下单当天发货,全面符合中国药典、FDA等多法规合规要求,能够为原料药生产、制剂研发及质量研究环节提供稳定可靠的标准物质支持。

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