Recent developments to share with you

Good News | Kangchuanji Pharmaceutical’s Sildenafil Citrate Orally Disintegrating Tablets Have Been Approved for Market Launch

2026-06-29


According to the drug approval document delivery information released by the NMPA, sildenafil citrate orally disintegrating tablets from Nanjing Kangchuanji Pharmaceutical Technology Co., Ltd. have been approved for marketing as a Class 4 generic drug under the new chemical drug registration classification, and are deemed to have passed the consistency evaluation.


Sildenafil citrate orally disintegrating tablets are indicated for the treatment of erectile dysfunction. These tablets do not require water; they dissolve rapidly in the mouth within seconds and provide a quick onset of action, meeting the needs of patients who seek convenient, fast-acting, and discreet oral medications, thereby offering a more flexible and diverse range of treatment options.

Sildenafil was the world’s first PDE5 inhibitor approved for the treatment of erectile dysfunction (ED). Its mechanism of action involves the selective inhibition of PDE5, which increases intracavernosal levels of cyclic guanosine monophosphate (cGMP), thereby relaxing smooth muscle and promoting blood inflow to achieve an erection. Numerous clinical studies and large‑scale real‑world data have consistently demonstrated that sildenafil exhibits significant efficacy and a favorable safety profile across a wide range of etiologies of ED.

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Good News | Kangchuanji Pharmaceutical’s Sildenafil Citrate Orally Disintegrating Tablets Have Been Approved for Market Launch

According to the drug approval document delivery information released by the NMPA, sildenafil citrate orally disintegrating tablets manufactured by Nanjing Kangchuanji Pharmaceutical Technology Co., Ltd. have been approved for marketing as a Class 4 generic drug under the new chemical drug registration classification, and are deemed to have passed the consistency evaluation.

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A Strong Start to the New Year – Kangchuanji Achieves Multiple Approvals

The new year begins with a wave of good news. Nanjing Kangchuanji Pharmaceutical Technology Co., Ltd. has made an excellent start, backed by professional expertise. According to NMPA drug approval information, the following products have been approved for marketing or have passed consistency evaluation: Famotidine Injection (2ml:20mg), Saxagliptin and Metformin Hydrochloride Extended-Release Tablets (2.5/1000mg and 5/1000mg), Isosorbide Dinitrate Tablets (5mg), Vitamin B6 Injection (100mg/ml), Cefdinir Granules (50mg/0.5g), and Ambroxol and Clenbuterol Oral Solution (1ml: ambroxol hydrochloride 1.5mg and clenbuterol hydrochloride 1μg). Among these, Isosorbide Dinitrate Tablets are the first in China to pass consistency evaluation. As a partner, Kangchuanji provided solid pharmaceutical R&D services, successfully supporting these drugs through the review and approval process.

2026-03-23