Hainan Shuangcheng Pharmaceuticals was approved by the State Drug Administration to issue Drug Registration Certificate to Octreotide Acetate Injection.

Basic drug information

1, drug name: octreotide acetate injection
2、Dosage form: Injection
3、Specifications: 1ml:0.1mg (C₄₉H₆₆₁₀O₁₀S₂)
4、Registration Classification: Class 4 chemical drugs
5、Drug Approval Number: State Drug License H20243223
6、Prescription drug/over-the-counter drug: prescription drug
7、Listed Licensee: Hainan Shuangcheng Pharmaceutical Co.
8、Manufacturer: Hainan Shuangcheng Pharmaceutical Co.
9, Production Address: Haikou City, Xiuying District, No. 16 Xingguo Road

Approved indications

Octreotide acetate injection is indicated for the control of symptoms and reduction of plasma levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly who are unable or unwilling to undergo surgery or radiation therapy. Treatment of patients with acromegaly who are unable or unwilling to undergo surgery, or treatment of patients with intermittent acromegaly for whom radiation therapy has not yet taken effect; alleviation of symptoms associated with functional gastroenteropancreatic (GEP) endocrine tumors; prevention of post-surgical complications of pancreatic surgery; and emergency treatment of bleeding due to gastro-esophageal varices in patients with cirrhosis to stop hemorrhage and prevent rebleeding, in conjunction with specific therapies, such as endoscopic sclerosing agents.

Impact on the company

This time, the company's product Octreotide Acetate Injection was declared and approved in accordance with the requirements of the State Drug Administration's new registration classification of chemical drugs, which is regarded as its passing of consistency evaluation, once again demonstrating the company's research and development capability of peptide products, further enriching the company's product pipeline and enhancing its competitiveness in the market.

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