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:7/21/2017)... know that PhRMA member companies invested $65.5 billion in research and ... generics and the supply chain account for 14 percent of total ... (7 percent)? Or that the United States ... high-growth biopharmaceutical startups? ... The biopharmaceutical industry accounts for 1 ...
(Date:7/17/2017)... , July 17, 2017  MedX Holdings, Inc., ... medical testing, strengthening and rehabilitation equipment, today announced the ... Program. MedX is considered the gold standard for the ... in specialized medical strengthening equipment. ... lease with the physician or practice who prescribe the ...
(Date:7/14/2017)... It should come as no surprise to anyone that ... of a crippling opioid epidemic. According to the Center ... deaths from opiate-based medications has quadrupled, Says, Dr. David ... 2001 to 2015". During this time, the prescription rate for ... a compelling link between prescription and eventual addiction. The problem ...
Breaking Medicine Technology:
(Date:7/26/2017)... ... July 26, 2017 , ... ... Solutions as part of their continued efforts to provide innovative offerings to their ... best IT resources and build dynamic, high-performing teams to address healthcare IT’s biggest ...
(Date:7/26/2017)... ... July 26, 2017 , ... The ... Process Validation and Process Validation Statistics Conferences in Bethesda, Maryland, 12 – ... challenges faced by process validation professionals and statisticians today. , “These conferences ...
(Date:7/26/2017)... (PRWEB) , ... July 26, 2017 , ... “We are ... offer the ability for patients to schedule an appointment online in real time,” said ... the Six Month Smiles provider directory will bring more Six Month Smiles patients to ...
(Date:7/26/2017)... ... , ... The Amnesty Rally 2017 will be held on Saturday, July 29 ... Drive in Monroe (adjacent to the Louisiana Purchase Gardens & Zoo). , The ... Monroe. Citizens can turn in unregistered, illegally-held and imitation guns to law enforcement officers ...
(Date:7/25/2017)... St. Louis, MO (PRWEB) , ... July 25, 2017 , ... ... (HDIS) in St. Louis, Missouri. The company has achieved record-breaking sales for ... multiple departments over the next 12 months. , The upcoming year offers excitement and ...
Breaking Medicine News(10 mins):