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Good News! Shijiazhuang No.4 Pharmaceutical Group’s Levofloxacin Ophthalmic Solution 0.488% (5 ml: 24.4 mg) and Compound Potassium Sulfate Granules Have Been Approved

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Honors Announcement

发布时间：2025-12-10

【概要描述】 On December 9, Shijiazhuang Sihua Pharmaceutical Group obtained manufacturing registration approval from the National Medical Products Administration for its Class 4 chemical drug levofloxacin ophthalmic solution 0.488% (5 mL: 24.4 mg) and its Class 3 chemical drug compound sodium picosulfate granules, which are deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.

Good News! Shijiazhuang No.4 Pharmaceutical Group’s Levofloxacin Ophthalmic Solution 0.488% (5 ml: 24.4 mg) and Compound Potassium Sulfate Granules Have Been Approved

On December 9, Shijiazhuang Sihua Pharmaceutical Group obtained production registration approval from the National Medical Products Administration for its Class 4 chemical drug levofloxacin ophthalmic solution 0.488% (5 mL: 24.4 mg) and its Class 3 chemical drug compound sodium picosulfate granules, which are deemed to have passed the evaluation of quality and therapeutic equivalence for generic drugs.

To date this year, the Group has received approval for 90 new products, surpassing last year’s full-year total, and a cumulative total of 163 drug varieties comprising 214 dosage forms have either passed or been deemed to have passed the consistency evaluation.

According to available information, levofloxacin ophthalmic solution is indicated for the treatment of blepharitis, hordeolum, dacryocystitis, conjunctivitis, meibomian gland dysfunction, and keratitis, as well as for aseptic preoperative prophylaxis in ophthalmic surgery. Compound sodium picosulfate granules are used for bowel preparation prior to colonoscopy and X-ray examinations, and may also be employed when necessary to cleanse the bowel before surgical procedures. Data from MeneNet show that in 2024, sales of levofloxacin ophthalmic solution across China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 340 million, with first-half 2025 sales reaching about RMB 190 million.

In recent years, the Group has closely aligned its efforts with market and clinical needs, vigorously promoting the diversification of product dosage forms. Notably, it has achieved significant progress in the ophthalmic formulation segment, successfully obtaining approval for four products across five specifications: moxifloxacin hydrochloride ophthalmic solution; timolol maleate ophthalmic solution at 0.5% (0.3 mL: 1.5 mg) and 0.25% (0.3 mL: 0.75 mg); ketotifen fumarate ophthalmic solution; and levofloxacin ophthalmic solution. These approvals have expanded therapeutic options for both the market and patients.

The Group has consistently prioritized accelerating high-quality development, steadfastly pursuing an innovation-driven growth strategy, and embracing the mission of researching, developing, and manufacturing more high-quality “Made-in-China” pharmaceuticals. By continuously fostering deep integration and coordinated development among the innovation chain, talent pipeline, industrial chain, and supply chain, the Group has powerfully catalyzed a steady stream of innovative breakthroughs, maintained a leading position in the industry in terms of the number of new product applications submitted and approved, significantly enhanced product accessibility, and effectively strengthened its innovative influence and market competitiveness.

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