BioDuro-Sundia has helped its partner, Tianjin Jun’an Bio-Pharmaceutical Co., LTD., obtain the Approval Notice of Supplement Application for Drug by The National Medical Products Administration (NMPA) of China for Gliclazide sustained release tablet. BioDuro-Sundia provided R&D services helping Tianjin Jun’an Bio to pass the quality and efficacy criteria required for Gliclazide approval as a Generic.
The dosage of Gliclazide sustained release tablets approved is 30mg, which is one of the first varieties evaluated by consistency in China; the original product was produced by Servier.
About gliclazide sustained release tablet
Gliclazide sustained release tablets belong to sulfonylureas hypoglycemic agents, whose main mechanism of action is to achieve hypoglycemic effect by stimulating the secretion of insulin. Gliclazide sustained release tablets are long-acting oral hypoglycemic drugs, which can be taken only once a day, and the effective time is about 24 hours. The drug is often used in combination with metformin tablets, acarbose tablets, pioglitazone and other drugs.
About Tianjin Jun’An Bio
Tianjin Jun’An Biopharmaceutical Co., Ltd. is a modern high-tech pharmaceutical enterprise, which mainly produces drugs for diabetes treatment, drugs for inhibiting gastric acid, drugs for treating hyperlipidemia, anti-infectants and biochemical drugs. The company was identified as a national high-tech enterprise in 2019, passed the national GMP re-certification once in November 2019, and was identified as a gazelle enterprise in 2020.
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.
BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.
For more information, visit: www.bioduro-sundia.com
About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.
For more information, visit: www.adventinternational.com
About Bridgewest Business Group
Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group’s private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.