Xinhua Pharmaceutical's Azithromycin Tablets Pass Consistency Evaluation

Regulation
โดย Jiemian·CN·Read original
Summary · why it matters

Shandong Xinhua Pharmaceutical Company announced that its wholly-owned subsidiary Shandong Zibo Xinda Pharmaceutical Company's azithromycin tablets, at a strength of 0.25 grams, have passed the generic drug quality and efficacy consistency evaluation by the National Medical Products Administration, and obtained the Drug Supplementary Application Approval Notice. This product is a Class A item under national medical insurance, indicated for a variety of infectious diseases, with sales of approximately 670 million yuan in Chinese public medical institutions in 2025. The company submitted the application materials in September 2025 and received approval in August 2026. This move is expected to enhance market competitiveness, but drug sales remain subject to industry policies and other factors.

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Shandong Xinhua Pharmaceutical Co Ltd
000756
▲ PositiveRegulationrelevance

Its subsidiary's azithromycin tablets passed the NMPA generic drug consistency evaluation, a regulatory approval expected to enhance market competitiveness.

Off-coverage companies 1

山东淄博新达制药有限公司Private▲ Positive
Regulationrelevance

The subsidiary's azithromycin tablets obtained NMPA consistency-evaluation approval and the Drug Supplementary Application Approval Notice.