Morphine

As a classic opioid analgesic, morphine acts by agonizing the μ-opioid receptors in the central nervous system, blocking pain signal transmission, and simultaneously inhibiting the emotional stress response induced by pain. It is a core medication for the management of moderate to severe pain. Its indications cover scenarios such as cancer pain, acute postoperative pain, chest pain caused by myocardial infarction, etc. Especially in the stepwise analgesic regimen for patients with advanced cancer pain, it is an irreplaceable basic medication. The applicable population includes terminal patients requiring long-term analgesia, perioperative patients, and some groups with acute and severe analgesia needs, and its clinical application has a history of more than 100 years.

The global market size of morphine analgesics is approximately USD 2.8 billion. Driven by factors such as the rising global cancer incidence rate and the increasing popularity of palliative care, the compound annual growth rate remains at around 4.2%. As a specially controlled narcotic drug, it has an extremely high market access threshold. The global production capacity is highly concentrated in compliant pharmaceutical enterprises in Europe and the United States and a small number of Chinese enterprises with the production qualification for narcotic drugs. The domestic market is supplied by about 10 enterprises with designated production qualifications. Prices are under unified national control, and the price reduction of preparation varieties covered by centralized procurement is stable in the range of 30%-40%, with no excessive market competition.

The original research enterprise of morphine is Mundipharma GmbH, and the original research trade names are "Ms Contin" (morphine sulfate sustained-release tablets). "OxyContin" is the trade name of oxycodone hydrochloride. The core compound patent of morphine has expired. The main marketed dosage forms in China include morphine sulfate sustained-release tablets (10mg, 30mg), morphine hydrochloride injection (10mg/1ml), etc. The original research morphine sulfate sustained-release tablets have been included in the Chinese Reference Listed Drug Catalog. As of October 2024, the CDE API Registration Platform of China has included a total of 15 morphine-related API registration information, among which 8 are in status A (approved for use in marketed preparations). A number of domestic enterprises have obtained approval for the marketing of morphine preparations. (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 morphine API. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day, which can fully meet the needs of API manufacturers and preparation R&D institutions for impurity research and quality control.