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双成药业(002693.SZ):宁波双成药品生产许可证变更

Hainan Shuangcheng Pharmaceuticals (002693.SZ): Ningbo Shuangcheng Pharmaceutical Production License Changes.

Gelonghui Finance ·  Jun 3 17:16

On June 3, Gelonghui reported that Hainan Shuangcheng Pharmaceuticals (002693.SZ) announced that its controlling subsidiary Ningbo Shuangcheng Pharmaceuticals Co., Ltd. ("Ningbo Shuangcheng") recently obtained a "Drug Production License" issued by the Zhejiang Provincial Drug Administration. This change mainly involves the addition of pharmaceutical GMP compliance inspection for Ningbo Shuangcheng's oral solid workshop capsule production line.

This change involves Pralibalin capsules. Pralibalin is a analog of the neurotransmitter γ-aminobutyric acid (GABA), and is a follow-up product of Gabapentin. Currently, Pralibalin capsules have been approved by the US Food and Drug Administration (FDA) for the adjuvant treatment of neuropathic pain related to diabetic peripheral neuropathy (DPN), post-herpetic neuralgia (PHN), partial-onset seizures for at least one month, myofascial pain, and neuropathic pain related to spinal cord injuries; Pralibalin capsules have been approved by the National Medical Products Administration for postherpetic neuralgia and fibromyalgia. Pralibalin capsules are included in the National Medical Insurance (2023 Edition) Category B Drug Catalogue and are listed in the Basic Medical Catalogue (2018 Edition).

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