“Innovative ‘API + Formulation’ Approach Yields Substantial Results! Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Two APIs—Dihydroxypropylxanthine and Acipimox”
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TIME:2025-04-23

Continuous innovation and steady accumulation ultimately lead to breakthroughs. On April 22, following the approval of three new products—dapagliflozin/metformin extended-release tablets (I) and arginine ibuprofen granules (0.2 g/0.4 g)—Shijiazhuang Sihua Pharmaceutical Group saw its subsidiary, Hebei Guangxiang Pharmaceutical Co., Ltd., successfully take over and secure approval on the same day for two active pharmaceutical ingredients it had developed and submitted: theophylline dihydrate and acipimox. This marks another significant achievement in the company’s pursuit of integrated development across both API and formulation segments.
According to available information, theophylline dihydrate is indicated for relieving wheezing symptoms in bronchial asthma, asthmatic bronchitis, and obstructive emphysema, and may also be used for wheezing caused by cardiogenic pulmonary edema. Acipimox can be employed as monotherapy or adjunctive therapy to reduce triglyceride levels in patients whose response to other treatments, such as statins or fibrates, is inadequate; it is indicated for the following conditions: hypertriglyceridemia (Fredrickson type IV hyperlipoproteinemia) and combined hypercholesterolemia and hypertriglyceridemia (Fredrickson type IIb hyperlipoproteinemia).
To date, the Group has received approval for a total of 74 bulk and specialty APIs, with Guangxiang Pharmaceutical accounting for 43 of these approvals. Previously, acipimox capsules were approved for registration in February 2025. The recent approval of acipimox API will further enhance the Group’s integrated “API-plus-formulation” product portfolio, providing robust assurance for subsequent market commercialization.
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