Tramadol

Moderate to severe pain is a core clinical challenge faced by patients after surgery, with cancer, and with chronic orthopedic diseases. Traditional opioid drugs have significant analgesic effects but carry a high risk of addiction, while non-steroidal anti-inflammatory drugs have an analgesic ceiling. The emergence of tramadol has filled the application gap between these two types of drugs. As a centrally acting opioid analgesic, it acts simultaneously on the μ-opioid receptor and the norepinephrine and 5-hydroxytryptamine reuptake pathways. With this dual mechanism, its analgesic potency is 1/10 to 1/6 that of morphine. It can not only relieve moderate to severe acute and chronic pain, but also has no obvious respiratory depressant effect at conventional therapeutic doses. At present, it is widely used for postoperative analgesia, cancer pain management, neuropathic pain, and emergency pain relief for fractures, toothache and other conditions, and the applicable population covers adult patients and children over 1 year old in need of analgesia.

At present, the global market size of tramadol preparations is stable at around USD 2.7 billion, and the annual sales in the Chinese market exceed RMB 3 billion. In recent years, with the advancement of the hierarchical analgesia policy and the rising demand for postoperative analgesia and chronic pain in the elderly, the compound annual growth rate has remained at 4% to 6%. The competitive landscape is dominated by generic drugs, with the original research product accounting for less than 15%. There are more than 200 preparation approvals in China. Tramadol hydrochloride sustained-release tablets and injections have been included in the national centralized procurement, and the winning bid price has dropped by more than 80% compared with the maximum price limit. The upstream API supply is dominated by domestic manufacturers, with overall sufficient production capacity, and cost control has become one of the core competitiveness of downstream preparation enterprises.

The original research enterprise of tramadol is Grünenthal, and the original trade name is "Tramal" (Chinese trade name "马伯龙"). Its core compound patent expired globally in 2002. The core dosage forms of the original research include tramadol hydrochloride sustained-release tablets (50mg, 100mg, 150mg, 200mg), injections (1ml:50mg, 2ml:100mg) and suppositories. Among them, multiple dosage forms have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Listed Drug Directory. In terms of the domestic market, more than 30 enterprises have obtained A status for their tramadol hydrochloride APIs through CDE registration, and more than 60 domestic tramadol preparations have been approved for marketing. (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 tramadol APIs. Most of the 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 including the Chinese Pharmacopoeia and FDA, and can fully support the needs of API registration and declaration, quality research and routine production quality control.