Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.
Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.
NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.
HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.
The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.
Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.
NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).
Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.
“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.
“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.
Big Events for Newscen's History
Year of 2003-----
Newscenwas registered in Tianjin Economy Technology Development Area(TEDA) with total registered capital of 25miion US Dollars. In December, Pharmaceutical Manufacture Permit was received from S-FDA.
Year of 2004-----
The product licenses and second grade New Drug Certificate for “Diagnostic Kit for Antibody to HIV(1+2) (Colloidal Gold) " was approved by s-FDA.GMP Certificate for Newscen's production facility was certified by s-FDA. In this year, Newscen was granted by the National Development and Reform Committee (NDRC) as “Model Manufacturing Basis For Biotechnology and Biomedical Engineering" and “Tianjin Significant Industrialization Project of High-technology".
Year of 2005-----
The company's board meeting dismissed the old administrative team and assigned the new general manager and reconstructed the new administrative team.“Constantly Surveying Foreign and Domestic Markets, Aiming At Providing A Variety of Important Products and Taking The Lead At Innovative Technology” had been set as company's operative strategy and“Honesty, verity, authenticity, and innovation", was determined as Newscen's persistent commitment.
Year of 2006-----
Newscen got new HCG, LH License approved by s-FDA ISO13485:2003 and ISO9001:2000 for Newscen's quality control system and CE certificates for HCG and LH were approved by TUV of Germany.
Year of 2007-----
FSH, URS License was approved by s-FDA and the High-Tech Enterprise Certificate was awarded by Science Committee of TEDA. Drug of Abuse test had got the CE Approval. The scientific research project—Nano super-paramagnetic particle was granted by Tianjin Scientific and Technology Committee as key supporting project. At the end of this year, the company re-constructed and switched from state-controlled enterprise into a private-controlled company.
Year of 2008-----
HBsAg, HCV License was approved by s-FDA. The project of Diagnostic Kit for Hepatitis C Virus Antibody was granted by the foundation of small and middleclass enterprises governed by Tianjin Science and Technology Committee.
Year of 2009-----
In the beginning of this year, a new important investor joined Newscen. The development goal has been set for company's next stage:establishment of Newscen Coast Biological Reagent Park and make the company go public in near future. Newscen passed the Nationals-FDA Quality System Evaluation for T Band HIV.
Year of 2010-----
TB Rapid Screen Test, HIV-1/ 2 Gold Rapid Screen Test got the registration certificate for medical device.“AIDS, Hepatitis, Rapid Diagnosis of In Vitro Biological of High-Tech Industrialization Demonstration Projects ” passed state acceptance. The successful development of the first multi-functional, universal“Rapid Immuno Assay Reader" got the registration certificate of medical device from state food and drug administration. ISO13485:2003 and ISO 9001:2000 for Newscen's Rapid Immuno Assay Reader were approved by TUV of Germany. Newscen has been granted by the National Development as “Tianjin Significant Industrialization Project of High-Technology".
Year of 2011-----
Newscen's “Universal Rapid Immuno Assay Reader and rapid test R&D Project "has been listed in “Tianjin Science and Technology Development of Key Enterprises Special Funds" and “The Sixth Batch of Industrialization of Key Projects of Independent Innovation In Tianjin China". Win “Tianjin Science and Technology of Key Enterprises” certificate and the Title of “ 100 Strong Enterprises In Tianjin City of China".
Year of 2012-----
"Quantitative Detection Kit and Reader For Reproductive System Development and Industrialization Project" has been listed in “Tianjin Science and Technology Development of Key Enterprises Special Funds". “Universal Rapid Immuno Assay Reader Project" win “Tianjin Science and Technology Innovation Fund For Key Enterprises". “Y.B.T." win the title of' Tianjin Famous Brand"
Year of 2013-----
"Rapid Immuno Assay Reader and rapid test R&D project" has been listed in “Tianjin Science and Technology Support Plan 2012-2014". CRP, PCT, mALB, TSH quantitative and semi-quantitative test got SFDA.
....................................
Our Service
Free Pre-Sales Consulting
We offer 12 hours quick pre-sales response and free consulting. Any kind of technical support is available for our customers.
Free Sample Making
Free Sample Making & Testing is available. We can provide the sample for free, freight is afforded by the customers.
Quick Delivery
Your order will be provided by us, we will try our best to make a quick delivery to all of you.
Strict Quality Control System
Adopt Advanced Equipment, set up a complete & strict quality control system, which ensures the excellent quality of our products.
OEM & ODM
we provide OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.
After-Sales Service
If any customers make quality complains, we will forward it to our service team. They will report directly to our factory manager. Usually, we will hold a meeting with production, purchasing, and packaging departments in 24 hours, and will respond in 24 hours with feedback and solution.
Newscen brings relevant Top talent , Entrepreneur returned from oversea and leading-edge Technology in Medical Test field together for a highly qualified professional team.
we have complete department system and special teams which effectively manage work of various aspects such as R & D, Marketing, Sales, Production, Quality Controlling, Operation, Management, Logistics, after-sales service ......etc.
working is the process of constantly solving various issues and questions from different customers, our professional Teams have high pragmatic and dedicated spirit , do best effort to propose constructive proposals and provide many solutions for customer who encounter different problems.
“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.
“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.
Welcoming you to be our Distributor or Agent, authorizing regional protection for partners, working and developing together to bring more value for people, health business and society, meantime, realizing your own career to be more and more stronger.
For more detailed information on the Rapid Test Products, please do not hesitate to contact us by email : global@rapid-testkit.com
Looking forward to working together with you !
