03.13 2025

Tianjin Pharma's Four APIs Obtain Brazilian GMP Certification, Marking Another Milestone in Global Market Expansion


On February 6, Tianjin Pharma, a subsidiary of Tianjin Pharmaceuticals Group, announced that four of its active pharmaceutical ingredients (APIs) — dexamethasone sodium phosphate, dexamethasone acetate, spironolactone, and betamethasone — have successfully passed the on-site GMP (Good Manufacturing Practice) certification conducted by the Agência Nacional de Vigilância Sanitária (ANVISA).


It is reported that APIs such as dexamethasone sodium phosphate and betamethasone are among the core product series of Tianjin Pharma, with broad market applications.


Dexamethasone sodium phosphate is commonly used for allergic and autoimmune diseases.


Dexamethasone acetate is primarily indicated for collagen diseases, such as rheumatoid arthritis, systemic lupus erythematosus, rheumatic heart disease, rheumatic fever, and dermatomyositis.


Spironolactone is a potassium-sparing weak diuretic, used to treat refractory edema associated with elevated aldosterone levels, as well as serving as an adjuvant therapy for cardiovascular diseases and hypertension.


Betamethasone is suitable for treating hyporeninemic hypoaldosteronism, orthostatic hypotension caused by autonomic neuropathy, and allergic or autoimmune inflammatory diseases.


The successful certification has laid the groundwork for the products to enter and further expand their presence in the Brazilian market, which is expected to positively impact the company's performance. Previously, Tianjin Pharma's dexamethasone sodium phosphate API had already received approval for market authorization from ANVISA in December 2024.