Gabapentin

Neuropathic pain is a common type of chronic pain in clinical practice. Traditional analgesic drugs have limited efficacy and prominent adverse reactions, and the advent of gabapentin provides a better option for the treatment of such diseases. As a γ-aminobutyric acid (GABA) analog, it does not directly act on GABA receptors, but specifically binds to the α2δ subunit of voltage-dependent calcium channels to reduce the release of excitatory neurotransmitters, thereby exerting analgesic, anticonvulsant and anxiolytic effects. In addition to being clinically used for the adjuvant treatment of postherpetic neuralgia and partial onset seizures in adults, it is also recommended by guidelines as the first-line treatment for diabetic peripheral neuralgia, fibromyalgia and other diseases, covering the medication population in multiple departments such as neurology, pain department and dermatology.

The global gabapentin market size has maintained steady growth in recent years. The overall market size in 2023 was approximately USD 1.8 billion, of which generic drugs accounted for more than 90%. In terms of the domestic market, the sales volume of gabapentin preparations in public medical institutions exceeded RMB 1.2 billion in 2024, with a compound annual growth rate maintained at around 7%. At present, the domestic preparation market is dominated by generic drugs. More than 30 enterprises have obtained approval for the marketing of their preparation products, and a total of 7 specifications have been included in the national centralized procurement. The average price reduction of the selected products has exceeded 80%, which further promotes the improvement of clinical accessibility, and the demand for upstream APIs continues to release with the implementation of centralized procurement.

The original developer of gabapentin is Pfizer, with the original brand name Neurontin. Its core compound patent in the United States expired in 2004, and the compound patent in China expired in 2001. The main dosage forms approved for the original product include capsules (100mg, 300mg, 400mg), tablets (600mg, 800mg) and oral solutions. The original product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. In terms of domestic API registration, more than 20 enterprises have obtained CDE registration numbers for gabapentin APIs, most of which are in status A (already used in marketed preparations). More than 30 domestic enterprises have obtained approval for the marketing of gabapentin preparations, covering mainstream dosage forms such as capsules and tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the R&D and production quality control needs of gabapentin, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in all links such as impurity research, quality standard establishment and release testing.