On July 1, Tianjin Pharmaceutical Holdings released an announcement that its betamethasone dipropionate has recently obtained the DMF First Adequate Letter (abbreviated as DMF FA Letter) issued by the U.S. Food and Drug Administration (FDA). This indicates the API meets the ANDA filing requirements of its downstream formulation clients.The betamethasone dipropionate API that secured the DMF FA Letter is a Type II drug substance. It delivers anti-inflammatory, anti-rheumatic and anti-allergic effects, and is clinically indicated for allergic and autoimmune inflammatory disorders, including neurodermatitis, vitiligo, urticaria, rheumatoid arthritis, lupus erythematosus, scleroderma and acute leukemia. Besides, its combination formulation with calcipotriol is a widely adopted therapy for psoriasis.The successful review approval reaffirms that the company’s API R&D capacity and quality management system have once again met stringent international standards. It injects new momentum into the overseas expansion of its API business, strengthens the product’s competitiveness within the global supply chain, and provides robust backing for the further advancement of the company’s internationalization strategy.

Source: Board Office of Tianjin Pharmaceutical Holdings, China Securities Journal · cnstock.com