2018-12-17

Sihuan Metformin Hydrochloride Tablet Passes Consistency Evaluation

News Center
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The product’s successful passing the consistency evaluation is the authoritative recognition of Sihuan's R&D capability, production and product quality and product efficacy, and also gives it an advantage in future market access, medical insurance payment and other areas.
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Recently, Metformin Hydrochloride Tablet (0.25g), a diabetes drug owned by SihuanPharmaceutical Holdings Group, has been approved by the State Drug Administration and has passed the evaluation on quality and efficacy of generic drug, and Sihuan has become the first domestic company to obtain an approval upon additional application based on consistency evaluation in connection with such drug.


Metformin Hydrochloride Tablet is a basic drug for treating diabetes, and is used in patients with type II diabetes whose blood sugar cannot be satisfactorily controlled by diet alone, especially those obese people and those accompanying with hyperinsulinemia. As a first-line drug for treating type II diabetes, Metformin is often used in combination with other oral hypoglycemic drug. According to recent research results, in addition to the hypoglycemic effect, Metformin also has multiple clinical benefits, including protection of cardio-cerebral vascular and improvement of non-alcoholic fatty liver disease. Because of its advantages in efficacy and accessibility, it has been listed as first-line drug for hypoglycemic treatment in the guidelines for the prevention and treatment of type II diabetes developed by professional academic organizations at home and abroad.


With the continuous increase in the incidence of hyperglycaemia in China, there is a stable market demand for Metformin preparations. According to Menet database, in 2017, Metformin achieved a sales of RMB 2.59 billion in (city-level public and county-level public) hospitals across the country and ranked second among domestic oral hypoglycemic drugs (CADN) in terms of market size.


Having passed the consistency evaluation earlier than others, Sihuan Pharmaceutical has undoubtedly seized the policy and market opportunities. The product’s successful passing the consistency evaluation is the authoritative recognition of Sihuan's R&D capability, production and product quality and product efficacy, and also gives it an advantage in future market access, medical insurance payment and other areas.

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