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Shisi Pharmaceutical Group: Entacapone Bidopa Tablets (II), Fluvoxamine Maleate Tablets, etc. have obtained drug production registration certificates

2024-08-07

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On August 7, Shisi Pharmaceutical Group announced on the Hong Kong Stock Exchange that the group has obtained the drug production registration approval from the National Medical Products Administration for Entacapone Bidopa Tablets (II) (entacapone 200mg, levodopa 100mg, carbidopa 25mg) and Fluvoxamine Maleate Tablets (100mg). Both belong to Class 4 chemical drugs and are deemed to have passed the consistency evaluation. Entacapone Bidopa Tablets (II) is the first domestic company to be approved. Entacapone Bidopa Tablets (II) are mainly used for adult Parkinson's patients with end-of-dose motor function fluctuations that have not been controlled by levodopa/dopa decarboxylase (DDC) inhibitor therapy, while Fluvoxamine Maleate Tablets are mainly used to treat depression and obsessive-compulsive disorder.

At the same time, the Group has obtained the drug production registration certificate for fat emulsion (10%)/amino acid (15)/glucose (20%) injection (1000ml and 1500ml) from the National Medical Products Administration. Both belong to Class 4 chemical drugs, which are deemed to have passed the consistency evaluation and are the second domestic company to be approved. This three-chamber bag injection is mainly used for parenteral nutrition when enteral nutrition is not feasible, insufficient or contraindicated.

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