Codeine

In the field of central antitussive and analgesia, codeine is a classic opioid receptor agonist. It exerts a potent antitussive effect by directly inhibiting the cough center in the medulla oblongata, and meanwhile acts on opioid receptors in the central nervous system to produce a moderate analgesic effect, with an analgesic potency approximately 1/12 that of morphine and lower addiction potential than morphine. Clinically, it is mainly used for severe dry cough and irritable cough caused by various reasons, especially suitable for patients with dry cough accompanied by chest pain. It can also be used for short-term relief of moderate pain, and is one of the commonly used drugs in clinical symptomatic treatment of respiratory diseases and pain.

The global market size of codeine API is approximately USD 230 million, with a compound annual growth rate maintained at around 2.1%. The core driving force of demand comes from the rising prevalence of chronic respiratory diseases and the steady growth of demand for postoperative analgesia. As a controlled narcotic drug, its market competition pattern is highly concentrated. Globally, only a small number of enterprises with production qualifications for narcotic drugs have supply capacity. The domestic market strictly implements a designated production system, the supply of compliant production capacity is limited, and the supply and demand have long been in a tight balance.

The original developer of codeine is Mallinckrodt Pharmaceuticals, and the original brand name is Codeine Sulfate. The core compound patents have fully expired in the 1950s. At present, the mainstream dosage forms on the market include tablets, injections and oral solutions. Commonly used specifications are 15mg and 30mg tablets, 15mg/1mL injection, etc. Multiple original dosage forms have been included in the FDA Reference Listed Drug Catalog. In China, the codeine APIs of several enterprises have obtained A status through CDE registration, and corresponding preparations such as codeine phosphate tablets and codeine phosphate oral solution have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for codeine API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of different scenarios such as drug R&D, quality research, and registration declaration.