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:4/19/2017)... , Tenn. and DALLAS , April ... EndoStim, Inc., announced that the first patients in ... the EndoStim device in the Lower Esophageal Sphincter Stimulation ... a minimally-invasive implantable device designed to provide long-term reflux ... neurostimulation. GERD affects nearly 65 million people ...
(Date:4/19/2017)... , April 19, 2017 ... stimulate an immune response in pets such as ... products are of various types such as Attenuated ... Toxoid Vaccines, DNA Vaccines and Recombinant Vaccines. Attenuated ... as virus or bacteria, which have been weakend ...
(Date:4/19/2017)... 2017  SARES•REGIS Group leased the first of ... Conejo Spectrum Business Park in Thousand ... Inc. , a biopharmaceutical company developing meaningful therapies ... have been underserved by scientific innovation, with an ... autoimmune and infectious disease. Before commencement ...
Breaking Medicine Technology:
(Date:4/24/2017)... ... 2017 , ... Veteran Theresa James awoke to the sound of her newly ... “Healing Tears,” James depicts every parent’s worst nightmare, when her three children were violently ... and situations throughout my divorce,” James said. “After the death of my children, I ...
(Date:4/24/2017)... ... ... My T Chai, a South African company that creates a number of ... a popular website specializing in sales of nutritional products. , Chai tea is ... It spread across Asia and Africa quickly, and today recipes vary from region to ...
(Date:4/24/2017)... ... April 24, 2017 , ... In 2017, up to ... approximately 25,000 of them will be malignant.(1) As research into precision medicine continues, ... healthcare model in the diagnosis and treatment of brain tumors. Healthcare facilities that ...
(Date:4/24/2017)... ... 2017 , ... As a former supermodel known for her timeless beauty, Joan ... single women is that she put all the words in her new book, "Manifest ... personal experiences and sparkling sense of humor have inspired her to write a book ...
(Date:4/24/2017)... ... April 24, 2017 , ... ... shows that over the last decade, student well-being has seriously declined. "When disenfranchised ... of formal education, join the Islamic State to turn the historic multi-ethnic and ...
Breaking Medicine News(10 mins):