Pyridostigmine

Myasthenia gravis is a rare autoimmune neuromuscular disease. Patients often suffer from muscle weakness, easy fatigue and other symptoms due to damaged acetylcholine receptors, and in severe cases, the respiratory muscles may be involved and life-threatening. As a reversible cholinesterase inhibitor, pyridostigmine bromide is the first-line basic drug for symptomatic treatment of this disease. Its mechanism of action is to inhibit cholinesterase activity, reduce the degradation of acetylcholine, and prolong the action time of neurotransmitters in the synaptic cleft, thereby improving muscle contraction function. It can also be clinically used to treat postoperative abdominal flatulence and urinary retention, as well as to antagonize the residual effect of non-depolarizing muscle relaxants. The applicable population covers adult and pediatric patients with myasthenia gravis, and the dosage needs to be adjusted according to individual tolerance.

The global market size of pyridostigmine bromide was approximately USD 420 million in 2023. Driven by factors such as the rising prevalence of myasthenia gravis and the improvement of the security policy for rare disease drugs, the compound annual growth rate is expected to remain at around 5.8% from 2024 to 2030. In terms of the domestic market, the currently approved and marketed pyridostigmine bromide preparations are mainly generic drugs, among which Shanghai Pharmaceuticals accounts for more than 90% of the domestic public hospital market share. In 2022, this product was included in the centralized procurement of the alliance of 11 provinces including Guangdong and Jiangsu, and the winning bid price decreased by about 41% compared with the previous price, which further improved the accessibility of drugs for patients, and also drove the sustained and steady growth of the demand for upstream API.

The original developer of pyridostigmine bromide is Roche, with the original brand name Mestinon, and its core compound patent expired globally in 1985. The main dosage forms approved for the original product include tablets (60mg), sustained-release tablets (180mg) and injections (1mg/mL, 5mg/mL). The original tablet has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Chinese List of Marketed Drugs. According to the domestic API registration platform, a total of 6 enterprises have obtained A-status registration numbers for pyridostigmine bromide API, and a total of 12 domestic preparations have been approved, mainly 60mg conventional tablets. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for pyridostigmine bromide, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D needs of API and preparation enterprises in quality research, consistency evaluation, registration and declaration, etc.