About
HS Biopharmaceuticlas Inc.
Our Company
HS Biopharmaceuticals, Inc., is a Califronia based Corporation, Established in June 2012. As the US affiliation of our parent group Jiaxing Hengjie Biopharma. Our purpose is to offer a more direct connection of the fine products manufactured by Jiaxing Hengjie Biopharma to the US Market
With our US based sales support and R&D team, We are able to provide the higest qulity of service to the local contract dietary supplement manufactuers and indivdial brands
Our Manufacturer
JIAXING HENGJIE BIOPHARMACEUTICAL CO.,LTD. , Founded in 2001, it is a national high-tech enterprise specializing in the production of chondroitin sulfate sodium series, glucosamine series, collagen series, shark cartilage powder series, hyaluronic acid series and other dietary supplements series. It is one of the early factories in China engaged in the production of chondroitin sulfate sodium series. The product quality standard conforms to the Chinese Pharmacopoeia, the United States Pharmacopoeia, the European Pharmacopoeia and Japanese Pharmacopoeia and other standards.
The factory covers an area of 20000 square meters, with more than 100 employees, modern production equipment and advanced testing instruments, 100000 level purification production workshop and perfect GMP quality control system, to ensure that the product quality meets the pharmacopoeia standard, safe and reliable.
The company attaches great importance to scientific and technological innovation, has applied for a number of utility models and invention patents, and has Jiaxing Municipal Scientific and technological research and development center with doctor as the discipline leader, ensuring product innovation and sustainable development of the enterprise.
Based on the business tenet of "quality and reality, science and technology innovation", the company provides professional services for its customers with a serious, dedicated and pragmatic attitude.
Our Quality System
HS company has established a perfect quality assurance system based on the requirements of cGMP, ISO9001 and ISO2000, which is updated every 3 years.
Since ISO approved in 2005,we have been insisting on high quality and innovation based on SOP requirements, strictly controlling product quality and operating in good faith. When fake products of chondroitin sulfate sodium appeared in domestic and foreign markets, LCSOLUTION high-performance liquid phase was first purchased, a large amount of data was accumulated. It was concluded that the difference between the detection results of E-HPLC (enzyme-labeled high-performance liquid phase) and CPC (potentiometric titration) was about 5%, which made an important contribution to the identification of genuine and fake chondroitin sulfate sodium. Meanwhile HS is the first company proposed to control the two standards of sulfate and chloride under the US Pharmacopoeia, and truly achieved the chondroitin sulfate sodium index fully complies with all the tests under the USP.
April 2012, FDA inspection officials came to our factory for a three-day audit and passed the audit. August 2012, HS obtained GMP certificate issued by NSF and listed on NSF official website. May 2014, HS was successfully registered in Ukraine, November 2015, HS obtained the registration of Japanese drugs, March 2017, the MSc certification was updated, March 2018, HS obtained the registration certificate of export food manufacturers, June 2019 HS obtained the API registration number: y2019000453, October 2019, the production license of chondroitin sulfate sodium (API) was successfully renewed.
HS company has a number of high sense of responsibility and rich professional experienced staff who carry out the work routine analytic testing to meet the requirements of different customer specifications. We have High Performance Liquid Chromatograph more than one, Infrared Spectrophotometer, Cetylpyridinium Chloride Automatic Titrator, Microbiological Testing Lab. We brought in highly educated personnel to undertake new analysis method development and validation, all documents and records are in order of control.
Our History
2008 Oct -- A GMP workshop (300,000 clean class) was built and put into service. It was upgraded to 100,000 clean class in 2011
2010 May -- Received the Drug Manufacturing License issued by the State FDA. It was renewed on Sep 2, 2019 and valid until Sep 1, 2024
2010 October --ISO9001 & ISO 22000 Verified. It was renewed on Oct.11, 2018 and valid until October 11, 2021.
2012 April --Pass the FDA site inspection with zero inspectional observation
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2012 August --Received the NSF-GMP certificate and listed as a GMP manufacturer of dietary supplements on NSF website and renew the certificate every year.
2012 December –DMF NO. of Chondroitin Sulfate received from USFDA: 26474.
2014 March---Successfully registered in Ukraine
2014 March--- MSC Verified for Shark Chondroitin and Shark Cartilage Powder. It was renewed on March 2, 2017 and valid until March 1, 2020.
2015 November---Obtained Japanese drug registration and valid until 2020.
2017 March---MSC certification was renewed in 2017 and 2019 and is valid until March 2023
2018 March---Obtain Certificate of Recording for Export Food Manufacturing Enterprises and valid until March 2023
2019 June--- Obtain API registration number Y20190000453
Certifications
