Tianjin Tianyao Pharmaceuticals (600488.SH): Dexamethasone dipropionate obtained FDA DMF FA Letter.
Jinyao Pharmaceutical (600488.SH) announced that the company recently received a DMF First Adequate Letter ("DMF FA Letter") issued by the Food and Drug Administration (FDA) of the United States. This indicates that the FDA has completed the scientific review of the company's dexamethasone sodium phosphate active pharmaceutical ingredient DMF file, which can meet the ANDA filing requirements of related formulation customers.
Tianjin Tianyao Pharmaceuticals (600488.SH) announced that it has recently received a DMF First Adequate Letter from the U.S. Food and Drug Administration (FDA), indicating that the FDA has completed the scientific review of the company's DMF file for dexamethasone sodium phosphate raw material and can meet the ANDA filing requirements of its associated formulation customers.
It is reported that dexamethasone sodium phosphate is a prodrug of the glucocorticoid medication dexamethasone. This product, in combination with dexamethasone sodium phosphate, has anti-inflammatory, anti-rheumatic, and anti-allergic effects, and is mainly used clinically to treat allergic and autoimmune inflammatory diseases such as neurodermatitis, vitiligo, urticaria, rheumatoid arthritis, lupus erythematosus, scleroderma, and acute leukemia. The combination of this product with calcipotriol is a widely used treatment for psoriasis in clinical practice.
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