Shijiazhuang Fourth Pharmaceutical Group Obtains Approval for Four New Products Within Three Days


Time:2023-03-24

Ten miles of spring breeze carry good news; with a thousand sails racing forward, now is the perfect moment. On March 24, the sodium lactate Ringer’s injection (500ml), submitted by Shijiazhuang Fourth Pharmaceutical Group, passed the National Medical Products Administration’s evaluation of generic drug quality and therapeutic equivalence. The group has become the second domestic enterprise to achieve this consistency evaluation for this product. This is the fourth product from the group to receive approval under the consistency evaluation program in the past three days.
A gentle spring breeze carries good news from ten miles away, and the time is ripe for a thousand sails to set forth. On March 24, the sodium lactate Ringer’s injection (500ml), submitted by Shijiazhuang Fourth Pharmaceutical Group, passed the National Medical Products Administration’s evaluation of generic drug quality and therapeutic equivalence. The group has become the second domestic enterprise to achieve this consistency evaluation for this product. This marks the fourth consistency-evaluation-approved product for the group in the past three days.
On March 22, Shijiazhuang Sihua Pharmaceutical Group obtained manufacturing approvals for Class 3 chemical drugs—the sustained-release theobromine tablets (0.4g) and the sorbitol-mannitol irrigation solution (3000ml)—and these approvals are deemed to have passed the consistency evaluation. Among them, the sustained-release theobromine tablets (0.4g) represent the first and only approval of this product in China; the sorbitol-mannitol irrigation solution (3000ml) is the second approval received for this product.
One day later, on March 23, the group’s achievements in consistency evaluation continued to expand as its injectable azithromycin (0.5g) obtained the drug registration approval for consistency evaluation from the National Medical Products Administration. Injectable azithromycin is primarily used to treat infections caused by susceptible bacteria, such as community-acquired pneumonia and pelvic inflammatory disease. Currently, Shijiazhuang Fourth Pharmaceutical Group already offers a variety of formulations including azithromycin raw material, azithromycin dispersible tablets, azithromycin dry suspension, azithromycin tablets, azithromycin glucose injection, and injectable azithromycin (lyophilized powder for injection). The “raw material + formulation” product chain for azithromycin is becoming increasingly comprehensive, creating greater room to meet diversified market demands and further tap into market advantages.
Following the successful completion of the consistency evaluation for this Sodium Lactate Ringer’s Injection (500 ml), the group now has a total of 42 drug varieties and 54 specifications that have either passed the consistency evaluation or are deemed to have passed it by analogy.

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