TPI Receives Production License for Its Anti-diabetic Drug Gliclazide Tablets from China’s SFDA
CHENGDU, China, June 1, 2011 /PRNewswire-Asia-FirstCall/ — Tianyin Pharmaceutical Co., Inc. (NYSE Amex: TPI), a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals today announced TPI has received the production license for its anti-diabetic drug Gliclazide Tablets (80 mg formulation) from China’s State Food and Drug Administration (SFDA). The national pharmaceutical certificate number for TPI’s new Gliclazide Tablets is also issued: H20113233.
For detailed information regarding this product or other products for TPI, please visit the official website of China’s SFDA at www.sfda.gov.cn. TPI is reaffirming the market entry of its Gliclazide in July this year.
Gliclazide is an oral anti-diabetic drug used for the control of hyperglycemia in gliclazide-response diabetes mellitus of stable, mild, non-ketosis prone, maturity-onset. It is used when proper dietary adjustment and exercise fail to reduce the blood sugar content or for conditions that are not suitable for insulin therapy.
Gliclazide is listed in the National Medical Reimbursement List (NMRL) of China. The approval and production license issuance brought TPI’s portfolio to 58 products in total, 24 of which are reimbursed by China’s Government Medical Insurance Program.
Diabetes is a group of metabolic diseases that are featured with high blood sugar with lack of insulin, or due to cells fail to respond to the insulin. This high blood sugar causes the classical symptoms: polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger). Later complications include vascular disease, peripheral neuropathy, and predisposition to infection. Treatment for Diabetes includes diet, exercise, and drugs that reduce glucose levels, such as insulin and oral antihyperglycemic drugs. Prognosis for Diabetes varies with degree of glucose control. There are two main categories of diabetes–type 1 and type 2, which can be distinguished by a combination of features. The terms including the age of onset (juvenile or adult) or type of treatment (insulin- or non-insulin-dependent) are no longer accurate because of overlap in age groups and treatments between disease types (www.merckmanuals.com).
Gliclazide is an oral anti-diabetic (hypoglycemic) drug which is classified as a sulfonylurea. Gliclazide is used for control of hyperglycemia in gliclazide-responsive diabetes of stable, mild, non-ketosis prone, maturity-onset or adult type. It is used when diabetes cannot be controlled by proper dietary management and exercise or when insulin therapy is not appropriate. Gliclazide binds to sulfonylurea receptors on the surface of the Beta islet cells found in the pancreas. This binding effectively closes the potassium ion channels. This decreases the efflux of potassium from the cell which leads to the depolarization of the cell. This causes voltage dependent calcium ion channels to open increasing the calcium influx. The calcium can then bind to and activate calmodulin which leads to exocystosis of insulin vesicles leading to insulin release (http://en.wikipedia.org/wiki/Gliclazide).
About Diabetes in China
Diabetes is one of the most common endocrine disorders in the world. The World Health Organization (WHO) estimates that worldwide, there are currently 220 million people living with diabetes. Diabetes is becoming an important chronic disease in China. In 2010, there were 95 million cases of diabetes in China, of which, 52 million and 43 million were found in rural and urban areas, respectively. By the end of 2020, it is estimated that the prevalence will increase to 117 million. The urbanization rates, obesity and population aging are several major drivers for the increasing type 2 diabetes incidence in China (http://www.researchandmarkets.com).
Headquartered at Chengdu, China, TPI is a pharmaceutical company that specializes in the development, manufacturing, marketing and sales of patented biopharmaceutical, modernized traditional Chinese medicines, branded generics and other pharmaceuticals. TPI currently manufactures a comprehensive portfolio of 58 products, 24 of which are listed in the highly selective national medicine reimbursement list, 7 are included in the essential drug list of China. TPI’s pipeline targets various high incidence healthcare indications. TPI has an extensive nationwide distribution network with a sales force of 730 sales representatives out of totaled 1,365 employees.
For more information about TPI, please visit: http://www.tianyinpharma.com.
Safe Harbor Statement
The Statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company’s filings with the Securities and Exchange Commission.
Tel: +86-28-8551-6696 (Chengdu, China) +86-134-3655-0011 (China) Address: 23rd Floor, Unionsun Yangkuo Plaza No. 2, Block 3, South Renmin Road Chengdu, 610041 China
SOURCE Tianyin Pharmaceutical Co., Inc.