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石四药集团(02005.HK):恩他卡朋双多巴片(II)及马来酸氟伏沙明片获药品生产注册批件

SSY Group (02005.HK): Entacapone/Levodopa and Fluvoxamine Maleate tablets (II) have obtained the pharmaceutical production registration certificate.

Gelonghui Finance ·  Aug 6 19:54

On August 7th, Jintai Group (02005.HK) announced that the group has obtained the drug production registration approval from the National Medical Products Administration (NMPA) for Entacapone and Levodopa/Carbidopa Tablets (II) (Entacapone 200mg, Levodopa 100mg, Carbidopa 25mg) and Fluvoxamine Maleate Tablets (100mg), both of which belong to the fourth category of chemical drugs and are equivalent to approved consistency evaluation drugs. Among them, Entacapone and Levodopa/Carbidopa Tablets (II) is the first domestically approved enterprise. Entacapone and Levodopa/Carbidopa Tablets (II) are mainly used for adult Parkinson's disease patients with end-of-dose motor fluctuations not adequately controlled by Levodopa/DDC inhibitor therapy, while Fluvoxamine Maleate Tablets are mainly used for the treatment of depression and obsessive-compulsive disorder. As previously announced by the company, the group's Entacapone raw material has been approved and registered by the NMPA as a raw material for use in listed preparations.

In addition, the group has obtained the drug production registration approval from the NMPA for Fat Emulsion (10%)/Amino Acid (15%)/Glucose (20%) Injection (1000ml and 1500ml), both of which belong to the fourth category of chemical drugs and are equivalent to approved consistency evaluation drugs. This three-chamber bag injection is mainly used for parenteral nutrition when enteral nutrition is not feasible, insufficient, or contraindicated.

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