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First New Product of 2026: Shijiazhuang Sihua Pharmaceutical Group’s Perindopril Amlodipine Tablets (III) Approved

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Honors Announcement

发布时间：2026-01-05

【概要描述】 The new year ushers in a fresh start for innovation. On January 5, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—Perindopril Amlodipine Tablets (III)—received production registration approval from the National Medical Products Administration and is deemed to have passed the evaluation of generic drug quality and therapeutic equivalence. This marks the group’s first newly approved product since the beginning of 2026. To date, the group has a total of 167 drug varieties comprising 218 dosage forms that have either passed or are deemed to have passed the evaluation of generic drug quality and therapeutic equivalence.

First New Product of 2026: Shijiazhuang Sihua Pharmaceutical Group’s Perindopril Amlodipine Tablets (III) Approved

The new year ushers in a fresh start for innovation. On January 5, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—Perindopril Amlodipine Tablets (III)—received production registration approval from the National Medical Products Administration and is deemed to have passed the evaluation of generic drug quality and therapeutic equivalence. This marks the group’s first newly approved product since the beginning of 2026. To date, the group has a total of 167 drug varieties comprising 218 dosage forms that have either passed or are deemed to have passed the evaluation of generic drug quality and therapeutic equivalence.

According to available information, Perindopril Amlodipine Tablets (III) are indicated for monotherapy in adult patients whose hypertension is not adequately controlled with monotherapy, or as an alternative treatment for essential hypertension that is well-controlled with combination therapy using perindopril and amlodipine at the same dose levels. The approved product specification is 10 mg of arginine perindopril and 5 mg of amlodipine besylate per tablet (calculated on the basis of C20H25ClN2O5). Data from MeneNet show that in 2024, sales of Perindopril Amlodipine Tablets (III) across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 250 million; in the first three quarters of 2025, sales reached about RMB 330 million. The market outlook is promising, with strong growth momentum.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has focused on meeting clinical needs and improving public health, continuously strengthening its efforts in therapeutic areas such as cardiovascular medicine. As a result, its product pipeline has grown increasingly diverse, with an expanding portfolio of innovative products, culminating in a robust portfolio of antihypertensive formulations—including nifedipine sustained-release tablets (II), felodipine sustained-release tablets, valsartan/amlodipine tablets (I), urapidil hydrochloride injection, bisoprolol/amlodipine tablets, and levamlodipine besylate tablets—thereby providing greater accessibility and more treatment options for the pharmaceutical market and patients alike.

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Good News! A New Specification of Compound Potassium Dihydrogen Phosphate Injection (2 ml) from Shijiazhuang Sihua Pharmaceutical Group Has Been Approved.

Sodium Glycero-phosphate Injection (10 ml: 2.16 g) by Shijiazhuang Sihua Pharmaceutical Group Has Been Approved