Shandong Saite Biotechnology Co., Ltd. (hereinafter referred to as the "Company") announced the relevant matters as follows: its holding subsidiary, Shandong Sri Pharmaceutical Co., Ltd., recently received the Approval Notice for Marketing Application of Chemical Active Pharmaceutical Ingredient of Triamcinolone Acetonide issued by the National Medical Products Administration (NMPA).
I. Registration Information of the Active Pharmaceutical Ingredient (API)
Name of the chemical API: Triamcinolone Acetonide
Registration number: Y20220000365
Packaging specifications: 0.5kg/barrel, 1kg/barrel, 2kg/barrel, 5kg/barrel
Application item: Marketing application for domestically produced chemical API
Manufacturing enterprise: Shandong Sri Pharmaceutical Co., Ltd.
Production address: South Section of East Outer Ring 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, upon 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.
Evaluation and approval result: A
II. Relevant Information about the API
Triamcinolone acetonide is an adrenocortical hormone drug. For topical external use, it can treat dermatitis, eczema and other infectious skin 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 via tendon sheath or joint capsule, it can effectively alleviate symptoms such as joint pain, swelling and stiffness.
