Friday, 26 February 2021


Sihuan Pharma obtains production approval for Gabapentin capsules

22 October 2020 | News

Sihuan Pharmaceutical is the third company that obtained production approval for the Product in China

Image source: Shutterstock

Image source: Shutterstock

Hong Kong-based Sihuan Pharmaceutical Holdings Group Ltd. (Sihuan Pharmaceutical) has announced that the National Medical Products Administration has granted drug production approval for the Group's gabapentin capsules (Product'). Sihuan Pharmaceutical is the third company that obtained production approval for the Product in China.

The Product is a Category B drug under the Drugs Catalogue for the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance is used to treat Postherpetic Neuralgia and Epilepsy. It can also be used for the adjuvant treatment of partial seizures in children aged 3 to 12 years old.

Gabapentin capsules demonstrate fast absorption through oral administration, good drug tolerance, minimal toxicity and side effects and excellent therapeutic effect. When consumed, it is not subject to metabolism, plasma protein binding and liver enzyme induction. The Product is able to penetrate the blood-brain barrier of a human brain with low possibility of interacting with other anti-epileptic drugs, and it can be used alone to treat general epilepsy or as a superimposed medication for refractory epilepsy.

Epilepsy is a common chronic neurological disease second only to stroke. It can occur in people of all ages, regions and races, with children and the elderly demographic groups with peak incidences. There are no less than nine million people suffer from epilepsy in China. As the patient population gradually increases, the market size of anti-epileptic drugs will also expand rapidly. In 2018, the market size of terminal chemical anti-epileptic drugs in China's public medical institutions was RMB4.9 billion.

The low rate of medical treatment for patients with the epilepsy in China offers a huge potential for future growth in the anti-epilepsy drug market.

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