Navigation Links
FDA Grants Petition for Removal From Import Alert
Date:2/14/2012

DETROIT, Feb. 14, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) maintains strict labeling requirements for Active Pharmaceutical Ingredients (APIs).  If an API does not maintain adequate labeling as per section 502(f)(1) of the Act, the FDA will consider the material to be misbranded.  Foreign APIs which are misbranded are subject to detention without physical examination under FDA's Import Alert 66-66 "Red List."

Once an API is placed on the Import Alert, further shipments into the United States are subject to additional paperwork, inspection and delay.  The requirements for removal from the Red List are defined by the FDA and are very specific.  The entire process can take a long time.

On behalf of a client, VPCI (Vectech Pharmaceutical Consultants International) is happy to announce the successful petition to the FDA for removal from the Import Alert.  Acting as the project coordinator, VPCI provided assistance throughout the entire process.

"This was a big victory for our client," said Craig Kruman, CFO and Director of Regulatory Administration for VPCI.  "Once a manufacturer is placed on the Import Alert it becomes very difficult to ship APIs into the United States.  This becomes a financial and administrative burden for the manufacturer.  And even more importantly, the resulting delays in the supply chain can lead to serious drug shortages."

Craig Kruman further went on to explain, "The best advice that VPCI gives to its clients is to avoid these issues in the first place.  Make sure that everything is properly filed, formatted and submitted before a shipment is made to the United States.  Make sure that all of the labeling requirements are met."

About VPCI
VPCI, Inc. (Vectech Pharmaceutical Consultants International) (www.vpcint.com) is a Pharmaceutical consulting firm that offers FDA regulatory guidance, manufacturing technology support, and high-level business development services.  With a global network of scientific and technical experts, VPCI has a broad ability to serve its clients dealing with a number of regulatory agencies.  VPCI offers audits and training to manufacturers, strictly following good manufacturing practices (GMP).


'/>"/>
SOURCE VPCI, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
2. Chinese SFDA Grants Immtech Fast Track Status
3. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
8. FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
9. FDA Grants NeoVistas Request to Expand CABERNET Trial to 30 Sites in the U.S.
10. FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - A Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronary Arteries
11. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... April 27, 2016 Shire plc (LSE: ... Poulton , Chief Financial Officer, will present at the Deutsche ... MA on Wednesday, May 04, 2016, 10:00 am ... be available on the Presentations and Webcasts section of Shire,s ... the webcast will be available on this same website for ...
(Date:4/27/2016)... April 27, 2016 Oasmia ... developer of a new generation of drugs within ... survival results for Paclical/Apealea in the Phase III ... with epithelial ovarian cancer. These preliminary results showed ... combination with carboplatin versus Taxol in combination with ...
(Date:4/27/2016)... FRANCISCO , April 27, 2016 ... expected to reach USD 2.06 billion by 2022, ... Research, Inc. Increasing consumer awareness towards a healthy ... the next seven years.      (Logo: ... diet intake coupled with rising health treatment expenditure ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... April 28, 2016 , ... Starting today, households ... mail from USA Medical Prescription Assistance Program. They are customized to reflect the ... package will include a ready-to-use, state-themed card and, in the near future, material ...
(Date:4/28/2016)... ... April 28, 2016 , ... The Aging in Motion Coalition ... an ICD-10-CM code for sarcopenia, giving it recognition for separate reporting and data collection. ... 1, 2016. , Sarcopenia is defined as a combination of low muscle mass and ...
(Date:4/28/2016)... ... April 28, 2016 , ... North Hollywood dentist , Dr. Hamid ... is essential when it comes to dental accidents or critical dental problems. These issues ... losing a tooth. Toothaches, knocked-out teeth, chipped teeth, and many other issues can lead ...
(Date:4/28/2016)... (PRWEB) , ... April 28, ... ... an invitation to those affected by a health insurance co-operative bankruptcy to ... proprietary process, individuals can receive over 1,500 FDA-approved prescription medications from over ...
(Date:4/28/2016)... , ... April 28, 2016 , ... For many, a diet is only as good ... if it does not look good. In addition, an individual cannot deny the importance of ... , The team, therefore, has worked to create a product range that could entice people ...
Breaking Medicine News(10 mins):