On July 7, Tianjin Pharmaceutical Co., Ltd. issued an announcement stating that betamethasone active pharmaceutical ingredient (API) has recently obtained a Letter of Conformity issued by the Brazilian Health Regulatory Agency (hereinafter referred to as “ANVISA”). This indicates that the product complies with local Brazilian regulatory requirements and can support downstream formulation customers in conducting drug registration filings. It will play a positive role in the company’s in‑depth development of the Brazilian market and improvement of operating performance.Betamethasone is indicated for low‑renin low‑aldosterone syndrome, orthostatic hypotension caused by autonomic neuropathy, as well as allergic and autoimmune inflammatory diseases. It is widely used for active rheumatic diseases, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, acute leukemia, etc. It is also applied in the comprehensive treatment of certain infections.This approval confirms that the company’s production and quality management system meets Brazilian pharmaceutical regulatory standards. Previously, Tianjin Pharmaceutical Co., Ltd. successfully completed the on‑site GMP inspection for this product in Brazil. Together with the newly‑granted compliance documentation for betamethasone API, the company is well‑positioned to directly meet the demands of local Brazilian pharmaceutical formulation manufacturers.Following dexamethasone sodium phosphate, betamethasone is another steroid API from Tianjin Pharmaceutical Co., Ltd. to secure ANVISA compliance qualification in Brazil. The successful approval further consolidates the company’s supply advantages for APIs in South America, optimizes its product portfolio for the Latin American market, and is expected to drive sustained revenue growth from overseas API businesses.Source: Board Office of Tianjin Pharmaceutical Co., Ltd.; China Securities Journal · cs.com.cn