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Microbial Fermentation Technology and Aseptic API Production Technology as the core

Topscience Biotech was established in 2005 and is a biotechnological innovative enterprise focusing on the R&D, production, sales, and service of bioactive with microbial fermentation technology and aseptic API production technology as the core. Topscience Biotech's main products include biochemical APIs, tissue engineering raw materials, functional skincare ingredients, new dietary raw materials, etc. The main product sodium hyaluronate series, which can be applied to medicine areas (such as orthopedics, ophthalmology), medical beauty (dermal fillers), cosmetics, health food, etc., to provide excellent quality and safety compliance raw material support for global partners to carry out differentiated competition.

Milestone

2023

2022

2021

2020

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2005

The first production line of sterile Sodium Hyaluronate was officially put into operation, and the sterile Sodium Hyaluronate was officially launched in China.

Topscience Biotech established the first sterile Sodium Hyaluronate production line in China. In the same year, it was awarded the title of "National Specialized, Refined, and New Small Giant Enterprise".

Topscience Biotech obtained the "Certificate of DMF Registration (Korea)" and "Form 41 Registration Certificate (India) " respectively for Sodium Hyaluronate API, officially entering the Korean and Indian API markets. In the same year, Topscience Biotech was awarded the title of "China's First New Dietary Ingredient Sodium Hyaluronate Substantively Equivalent Certification Enterprise", and obtained a food production license. Also Topscience Biotech won the "Kosher Certificate" for Sodium hyaluronate for the first time.

Topscience Biotech was awarded the "Exportation Certificate of a Pharmacetical Product (India)" for Sodium Hyaluronate for the first time.

Topscience Biotech obtained the Certificate of Good Manufacturing Pratice for Pharmaceutical Products, which lays a solid foundation for Sodium Hyaluronate to enter the domestic raw material drug supply market.

Topscience Biotech obtained the Food Facility of Certificate of Registration (US).

the dedicated production workshop for pharmaceutical grade Sodium Hyaluronate was officially put into use.

Topscience Biotech was awarded the title of "Shandong Engineering Laboratory". In the same year, Topscience Biotech was awarded the "ATTESTATION OF CONFORMITY - ECOCERT COSMETICS" and "ATTESTATION OF CONFORMITY - COSMOS" for sodium hyaluronate for the first time.

Topscience Biotech obtained the certificate of Suitability (CEP) for Sodium Hyaluronate. Topscience Biotech entered the supply chain of sodium hyaluronate apis officially in EU.

Topscience Biotech accelerated its layout in the field of cosmetics raw materials, achieving mass production of α-arbutin and simultaneous research and development of AA2G. In the same year, it was awarded the "Accreditation Certificate of Foreign Drug manufacturer (Japan)" and the "Written Conformation for Active Substance Exported to EU ". Topscience Biotech passed the "Halal Assurance System Certificate" for Sodium hyaluronate and α- Arbutin for for the first time.

Topscience Biotech won the "Shandong Patent Award" and the "Shandong Advanced Small and Medium Enterprises" awards.

Topscience Biotech was approved to establish an academician workstation; Awarded the title of "Provincial Strategic Emerging Industry". The company's products obtained three system certificates for the first time: Quality Management System, Environmental Management System, and Occupational Health and Safety Management System.

Topscience Biotech obtained the Drug Production License. In the same year, it was awarded such as the "Shandong Provincial Enterprise Technology Center" and the "Shandong Provincial Major Special Project for the Transformation of Independent Innovation Achievements".

Topscience Biotech was awarded the title of "Innovative Enterprise in Shandong Province".

Western site located, which lay a solid foundation for the company's long-term development and capacity expansion. In the same year, it was awarded the "Accreditation Certificate of Foreign Drug manufacturer (Japan)".

Topscience Biotech went into the fast track for production, R&D, and sales for Sodium hyaluronate. In the same year, it was awarded the "Small and Medium sized Enterprise Technology Innovation Fund of the Ministry of Science and Technology of China" and "National High-tech Enterprise".

Topscience Biotech Established, Chondroitin Sulfate Sodium and Menotropins series mass production started.

Quality & Certifications

Drug manufacturing Certificate

GMP Certificate

CEP of SH1.3

CEP of SH2.2

CEP of SH3.0

Certificate of KDMF Registration

Certificate of Form 41 Registration

ECOCERT

COSMOS

HALAL

Facility's Certificate of FDA Registration

VeganSu

Kosher

Written Confirmation for Active Substances Exported to EU

IOS 14001 (EMS)

IOS 45001 (OHSMS)

IOS 9001 (QMS)

As a manufacturer of Sodium Hyaluronate raw materials, Topscience Biotech adhering to the philosophy of "creating benefits with service, winning reputation with quality" and the corporate mission of "seeking well-being for human health", and regards giving back to scientific research as the corporate social responsibility. To support raw materials for scientific research related to Sodium Hyaluronate, Topscience Biotech has established ties with many universities and launched raw material Sodium Hyaluronate donation activities for universities and scientific research institutions. The activity is effective for a long time.

Production Workshops