PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: Werbeagentur & PR-Agentur co-operate

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

EDQM Suspends Certificates of Suitability for Chinese APIs - The European Directorate for the Quality of Medicines & HealthCare has suspended Certificates of Suitability of four APIs manufactured in China. In consequence, pharmaceutical manufacturers will have to re-assess other APIs by the same manufacturers
EDQM Suspends Certificates of Suitability for Chinese APIs

 

NewswireToday - /newswire/ - Muenster, North Rhine-Westfalia, Germany, 2009/04/22 - The European Directorate for the Quality of Medicines & HealthCare has suspended Certificates of Suitability of four APIs manufactured in China. In consequence, pharmaceutical manufacturers will have to re-assess other APIs by the same manufacturers.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

On April 14th, 2009 the European Directorate for the Quality of Medicines & HealthCare (EDQM) has suspended the Certificates of Suitability of four active pharmaceutical ingredients (APIs) manufactured in China. Two Benzylpenicillin products (R0-CEP 2004-001-Rev 00, R0-CEP 2004-017-Rev 00) of the company Hebei Huari Pharmaceuticals Ltd. as well as Dihydrostreptomycin sulphate (R1-CEP 2000-069-Rev 00) and Neomycin sulphate (R0-CEP 2001-317-Rev 02) of Sichuan Long March Pharmaceutical Co. Ltd are affected. "The EDQM auditors have obviously detected that these APIs are not manufactured according to the submitted documentation or in line with the requirements of ICH Q7", explained Dr. Wolfgang Heisig from the blue inspection body GmbH the proceedings of the EDQM. "Since the associated risk has changed, European pharmaceutical manufacturers should now also assess those APIs manufactured in the same premises, which have not been objected".

Already in mid of March the "Certificate of Suitabilty" for Clindamycin phosphate (R0-CEP 2003-060-Rev 00) of Zhejiang Pharmaceutical Co. Ltd. had been suspended by the EDQM. The Spanish Ministry of Health had thereupon demanded to recall 14 batches of medicinal products which contained the objected Clindamycin phosphate. In addition, GMP audit reports of Chinese suppliers were asked for from the pharmaceutical manufacturers.

"We currently do not know whether other health authorities will follow in that direction", comments Dr. Wolfgang Heisig. However, pharmaceutical companies using APIs from the affected companies should act now. He illustrated: "A change of the supplier is not always mandatory. Additional measures such as GMP audits and more detailed quality analyses may also be appropriate actions which should in advance be confirmed with the relevant authority."

About The blue inspection body GmbH
The blue inspection body GmbH (blue-inspection.com) examines the Good Manufacturing Practice (GMP) of pharmaceutical companies around the globe. Third-party audits by blue efficiently relieve manufacturing authorisation holders, API suppliers and API manufacturers. The blue inspection body GmbH is the first independent and accredited service provider for GMP audits within the European Union.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Werbeagentur & PR-Agentur co-operate

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


EDQM Suspends Certificates of Suitability for Chinese APIs

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Christian Rieke - Co-Operate.net 
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Werbeagentur & PR-Agentur co-operate securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Werbeagentur & PR-Agentur co-operate / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

BD Announces Adoption of Windows 10 ‘Internet of Things’ for the Pyxis™ ES System
Greenphire Named to Deloitte 2016 Technology Fast 500™
Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting
BD Collaborates with JDRF to Focus on Extended Wear Innovations for Insulin Infusion Delivery
BD Launches First Syringe Designed for Use with Humulin® R U-500 Insulin
MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association
BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Greenphire Receives EU-US Privacy Shield Certification
The 2016 Georges Mathé Prize Recognizes Research on the Immunological Determinants of the Response to Breast Cancer Treatment
MDxHealth Announces Agreement with HIFU CLINIC Prostate Cancer Center for Distribution of SelectMDx in Poland
First Patient in Malaysia Receives TheraSphere™ Radioembolisation Therapy
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) Prefilled Syringe
BTG and Mirada Medical Announce CE Mark Certification for Simplicit90Y Dosimetry Software in Europe
FDA Grants Priority Review to Genentech’s Lucentis® (Ranibizumab Injection) Supplemental Biologics License Application
Genentech’s TECENTRIQ® (Atezolizumab) Shows Significant Survival Advantage Compared to Chemotherapy

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  NAKIVO, Inc.

Visit  BizJobs.com





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)