Kudos! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Its Fifth New Product of the Year


发布时间:2024-01-18

【概要描述】 Innovation has gotten off to a strong start: on January 18, Shijiazhuang Sihua Pharmaceutical Group received production registration approval from the National Medical Products Administration for its fifth new product since the beginning of the year—potassium chloride injection (20 mL: 3 g)—which is also deemed to have passed the consistency evaluation.
Innovation has gotten off to a strong start: on January 18, Shijiazhuang Sihua Pharmaceutical Group received production registration approval from the National Medical Products Administration for its fifth new product since the beginning of the year—potassium chloride injection (20 mL: 3 g)—which is also deemed to have passed the consistency evaluation.
To date, the Group has either obtained or is deemed to have obtained approval under the Consistency Evaluation for a total of 72 drug varieties comprising 96 dosage forms.
Previously, the group’s polypropylene ampoule–packaged potassium chloride injection (10 mL: 1.5 g) received approval from the National Medical Products Administration in November 2023 after passing the evaluation of generic drug quality and therapeutic equivalence, making it the third company to obtain such approval. The recent approval of the potassium chloride injection (20 mL: 3 g) will play a positive role in further expanding the product portfolio for this dosage form and in boosting and enhancing the product’s competitive edge.
According to available information, potassium chloride injection is primarily used for the treatment and prevention of hypokalemia, as well as for the management of premature beats or rapid arrhythmias caused by digitalis toxicity.

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