Pregabalin

Chronic pain diseases such as neuropathic pain and fibromyalgia have long been difficulties in clinical treatment due to their protracted course and high recurrence rate, and the advent of pregabalin provides a better option for the management of such diseases. As a γ-aminobutyric acid (GABA) receptor antagonist, it exerts analgesic, anticonvulsant and anxiolytic effects by inhibiting the α2-δ subunit of voltage-dependent calcium channels in the central nervous system and reducing the release of excitatory neurotransmitters. At present, its clinically approved indications include postherpetic neuralgia, diabetic peripheral neuropathic pain, fibromyalgia, adjunctive therapy for partial onset seizures of epilepsy, etc. The applicable population covers adults and adolescent patients of specific age groups. Due to the low incidence of adverse reactions and few drug interactions, it has been recommended as a first-line drug for chronic neuropathic pain by multiple international guidelines.

The global pregabalin market size has maintained a steady growth trend after the patent expiration. In 2023, the market size was approximately USD 3.8 billion, of which generic drugs accounted for more than 70%. In terms of the Chinese market, the compound annual growth rate of pregabalin sales at the terminal of public medical institutions has remained at around 15% in recent years, and the sales exceeded RMB 900 million in 2023. At present, there are more than 20 domestic generic drug manufacturers, and the winning bid price in centralized procurement has dropped by more than 80% compared with the price of the original research drug, leading to a significant improvement in accessibility, and the demand in the primary market still has large room for release.

The original research enterprise of pregabalin is Pfizer, with the trade name "Lyrica". Its core compound patent expired in the United States in 2018 and in China in 2019. The main dosage forms approved for the original research drug include capsules (25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg) and oral solutions, which have been included in the Chinese *Catalogue of Reference Preparations of Chemical Drugs* and the FDA reference preparation catalogue. Up to now, there are more than 30 registration numbers of pregabalin active pharmaceutical ingredients (APIs) in China, most of which are in status A and can be marketed through associated review. The domestically approved pregabalin preparations cover multiple dosage forms such as capsules, sustained-release tablets and oral solutions. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of pregabalin impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The full range of products meets the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for links such as quality research, stability study, and registration declaration of API and preparation enterprises.