Shandong Saituo Biotechnology Co., Ltd. (hereinafter referred to as the "Company") announces that its holding subsidiary, Shandong Sire Pharmaceutical Co., Ltd., recently received the "Approval Notice for Marketing Application of Chemical Active Pharmaceutical Ingredient" for Triamcinolone Acetonide issued by the National Medical Products Administration (NMPA). The relevant information is hereby announced as follows:
I. Registration Information of the Active Pharmaceutical Ingredient (API)
Name of chemical API: Triamcinolone Acetonide
Registration No.: Y20220000365
Packaging specifications: 0.5kg/barrel, 1kg/barrel, 2kg/barrel, 5kg/barrel
Application item: Marketing application for domestically produced chemical API
Manufacturer: Shandong Sire Pharmaceutical Co., Ltd.
Production address: South Section of Dongwaihuan Road, Dingtao District, Heze City, Shandong Province
Approval conclusion: In accordance with the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, this product meets the relevant requirements for drug registration and is approved for registration. The quality standards, labels and production processes shall be implemented in accordance with the attached documents.
Review and approval result: A
II. Relevant Information of the API Triamcinolone Acetonide is an adrenocortical hormone drug.
For topical use, it can treat dermatitis, eczema and other skin infectious diseases; for intramuscular injection, it can be used for diseases treated with corticosteroids, such as allergic diseases, skin diseases, diffuse rheumatoid arthritis and other connective tissue diseases; for intra-articular injection, intracapsular injection, or administration through tendon sheaths or joint capsules, it can effectively treat symptoms such as joint pain, swelling and stiffness.
