Navigation Links
Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines
Date:5/24/2013

BEIJING, May 24, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced that Sinovac Beijing, the main operating subsidiary company of Sinovac, obtained the Certificate of Good Manufacturing Practices for Pharmaceutical Products (GMP Certificate) from the China State and Food Administration (CFDA) for its proprietary vaccines, its Haidian district bulk production plants, and its Changping filing and packaging facility. The GMP certificate covers Sinovac Beijing's vaccines commercialized in China and approved for stockpiling, inclusive of hepatitis A vaccine (human diploid cell), inactivated; hepatitis A and B combined vaccine; influenza vaccine (split virion), inactivated; pandemic influenza vaccine (inactivated, adjuvanted); pandemic influenza vaccine (split virion, adjuvanted); H1N1 influenza A vaccine (Split Virion, inactivated) The GMP certificate is valid for five years starting from April 17, 2013.

New GMP standards were implemented in China by the CFDA in March 2011. These new standards are in line with international standards. According to the notice for the implementation of new GMP guidelines (2010 version) issued by CFDA in February 2011, all China-based vaccine manufacturers are required to pass the new GMP certification by the end of 2013.

In December 2012, the CFDA conducted a on-site inspection on Sinovac Beijing's production plants in Haidian district and the new filling and packaging line in Changping district according to the Good Manufacturing Practice for Drugs (2010 Revision), the new GMP guidelines. The CFDA granted Sinovac the GMP Certification in April 2013 following the March 2013 public notification period.

Dr. Weidong YIN, Chairman,
'/>"/>

SOURCE Sinovac Biotech Ltd.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Sinovac to Host Conference Call to Report First Quarter 2012 Unaudited Financial Results
2. Sinovac Reports Unaudited First Quarter 2012 Financial Results
3. Sinovac Reports Progress in EV71 Vaccine Phase III Clinical Trial and Commercialization Preparation Status
4. Sinovac Schedules 2012 Annual Meeting of Shareholders
5. Sinovac to Host Conference Call to Report Second Quarter 2012 Unaudited Financial Results
6. Sinovac Reports Unaudited Second Quarter 2012 Financial Results
7. Sinovac Holds 2012 Annual General Meeting of Shareholders
8. Sinovac Receives Beijing CDC Tender Award to Supply Seasonal Flu Vaccine Anflu(R) to Beijing Citizens
9. Sinovac to Host Conference Call to Report Third Quarter 2012 Unaudited Financial Results
10. Sinovac Reports Unaudited Third Quarter 2012 Financial Results
11. Sinovac EV71 Vaccine Phase III Top-Line Results Presented at 13th Annual World Vaccine Congress & Expo
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2015)... 2015 Amgen (NASDAQ: AMGN ) ... Application (MAA) to the European Medicines Agency (EMA) ... 416) for the treatment of secondary hyperparathyroidism (SHPT) ... on hemodialysis therapy. If approved, etelcalcetide will be ... intravenously. Etelcalcetide is a novel calcimimetic ...
(Date:9/2/2015)... Miss. , Sept. 2, 2015   Gulf Coast Tattoo ... removal services with the cutting-edge Astanza Duality laser in ... unwanted ink erase their tattoo regret and take back control of ... but extends its services to Biloxi ... region. "With tattoo regret being as prevalent as it ...
(Date:9/2/2015)... 2, 2015 Research and Markets ( ... "An Introduction to Medical Device Software: Regulations ... conference to their offering. ... the regulations and requirements that apply to Medical ... using real life examples and state-of- the-art practices ...
Breaking Medicine Technology:Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 2Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 3Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 4Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 5Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 6Amgen Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 7Gulf Coast Tattoo Removal Delivers Unrivaled Tattoo Removal Results To Biloxi And Gulfport With Astanza Duality 2An Introduction to Medical Device Software: Regulations and Requirements Course - London, UK - November 2-3, 2015 2
... 2012  BioElectronics Corporation (OTC-PINK: BIEL), the maker of ... today announced the completion of a randomized, controlled ... ActiPatch® product.  ActiPatch uses pulsed electromagnetic field therapy ... of injured tissue. A double ...
... Lupus Research Institute (LRI) applauds our colleagues at ... to help healthcare professionals screen, diagnose and treat lupus nephritis, ... the ACR website , the new guidelines are just ... Research. An estimated one third of people with ...
Cached Medicine Technology:BioElectronics' ActiPatch Reduces Muscle Soreness in Runners 2New Published Guidelines to Help Physicians Diagnose and Treat Lupus Kidney Disease 2
(Date:9/2/2015)... , ... September 03, 2015 , ... ... and frequently listed among the most influential leaders in healthcare, will offer the ... Coalition, to take place October 15-16, 2015, in Palm Harbor, Florida, at the ...
(Date:9/2/2015)... ... September 03, 2015 , ... One can hardly argue against the fact ... do laptops and personal computers. These devices are being used as GPS, to make ... of mobile dating apps, STD positive singles can now join the prestigious social ranks ...
(Date:9/2/2015)... ... ... Sara Bleich, Ph.D., associate professor of health and policy ... recognized scholar on obesity prevention and control, has been selected for the prestigious ... graduate of Garrison Forest School, an all-girls’ independent school in Owings Mills, Md., ...
(Date:9/2/2015)... DC (PRWEB) , ... September 03, 2015 , ... ... of nominations to determine who among America’s policymakers, public servants, activists, corporate executives, ... the nation’s health care. This year, that process led the magazine to tap ...
(Date:9/2/2015)... ... September 02, 2015 , ... The CRISPR-Cas9 system ... complex of the Cas9 nuclease with either a chimeric single guide RNA (sgRNA) or ... of any given guide RNA (sgRNA or crRNA) to create a break in the ...
Breaking Medicine News(10 mins):Health News:ACO Coalition Meeting to Feature Leapfrog’s Leah Binder 2Health News:ACO Coalition Meeting to Feature Leapfrog’s Leah Binder 3Health News:Herpes-datingsites.com Recently Added Reviews of 5 STD Dating Apps for STD Positive Singles 2Health News:Dr. Sara Bleich, Garrison Forest Graduate, Selected for 2015-16 Class of White House Fellows 2Health News:NLN CEO Dr. Beverly Malone Named One of 100 Most Influential in Health Care 2Health News:NLN CEO Dr. Beverly Malone Named One of 100 Most Influential in Health Care 3Health News:GE Healthcare Webinar Discusses Improvements to CRISPR-Cas9 Gene Editing 2Health News:GE Healthcare Webinar Discusses Improvements to CRISPR-Cas9 Gene Editing 3Health News:GE Healthcare Webinar Discusses Improvements to CRISPR-Cas9 Gene Editing 4
... , , , ANNAPOLIS, ... PIP ), a biodefense company developing medical countermeasures against biological ... agreements for the issuance of 2-year, 10% unsecured senior convertible ... private placement of approximately $19.3 million. , , ...
... July 27 Health Robotics today announced,that it has ... to market,implement, and support its I.V. Workflow Engine and ... North America. One of,its software modules (OncoCube) has already ... University of Colorado Hospital [Denver], in,addition to all-digital ...
... , , , ... reveals that adults living in the country,s fifth largest city are ... and complex conditions. Many commonly used therapy classes including drugs to ... have experienced increases in adults 20 and older. , ...
... , Trinitas Comprehensive Cancer Center in Elizabeth, ... chemotherapy program in place , , LOS ... a variety of cancers--along with projections from the National Comprehensive Cancer Network ... by 2013--raise questions for both clinicians and patients with regard to the ...
... COLD SPRING HARBOR, N.Y., July 27 AccuVein LLC, ... illumination device, today announced that its quality system has received ... to customers around the globe AccuVein,s commitment to the quality ... and delivery procedures. , , ...
... , FRANKLIN, Mass., July 27 PLC ... innovative cardiac and vascular medical device-based technologies, today announced it ... capabilities provided by RenalGuard(R) from the Canadian Intellectual Property Office ... patent for RenalGuard in Canada. , , ...
Cached Medicine News:Health News:PharmAthene, Inc. Announces $19.3 Million Private Placement of Convertible Notes and Common Stock Warrants 2Health News:PharmAthene, Inc. Announces $19.3 Million Private Placement of Convertible Notes and Common Stock Warrants 3Health News:PharmAthene, Inc. Announces $19.3 Million Private Placement of Convertible Notes and Common Stock Warrants 4Health News:Health Robotics Announces American Joint Venture With i.v.SOFT 2Health News:Health Robotics Announces American Joint Venture With i.v.SOFT 3Health News:Chronic and Complex Diseases on the Rise in Philadelphia: Adults Using More Medications to Treat Chronic Conditions 2Health News:Chronic and Complex Diseases on the Rise in Philadelphia: Adults Using More Medications to Treat Chronic Conditions 3Health News:Chronic and Complex Diseases on the Rise in Philadelphia: Adults Using More Medications to Treat Chronic Conditions 4Health News:Oral Chemotherapy Offers Patients a More Convenient, Less Invasive Treatment Option 2Health News:Oral Chemotherapy Offers Patients a More Convenient, Less Invasive Treatment Option 3Health News:AccuVein Achieves Quality System Milestone 2Health News:Canada Grants PLC Systems First Patent for RenalGuard(R) 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: