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:2/23/2017)... Feb. 23, 2017  Genesis Healthcare Services has merged ... was made by Bill Monast , President and ... and Nathan Feltman , executives with Home Health ... LLC. This acquisition helps Hospice Cloud ... technology enabled durable medical equipment (DME) solutions for the ...
(Date:2/23/2017)... Research and Markets has announced the addition of the "Menopause ... ... Drugs Price Analysis and Strategies - 2016, provides drug pricing data and ... questions: What are the key drugs marketed ... Global Menopause market? What are the unit prices and ...
(Date:2/23/2017)... LA JOLLA, Calif. , Feb. 23, 2017 /PRNewswire/ ... biopharmaceutical company leading the discovery and development of innovative ... quarter and full year 2016 financial results on Thursday, ... Regulus will host a conference call and webcast on ... discuss fourth quarter and full year 2016 financial results ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... The Radiology Business Management Association ... marketing programs at the annual Building Better Radiology Marketing Programs conference, held ... in Fort Worth, Texas. Nine awards are given out in five categories. They are:, ...
(Date:2/23/2017)... , ... February 23, 2017 , ... ... of Justice jointly issued a letter to withdraw previous guidance issued ... their gender identity. The guidance issued in May 2016 by the Obama Administration ...
(Date:2/23/2017)... Angeles, CA (PRWEB) , ... February 23, 2017 , ... ... first two episodes of WE TV’s “Mama June: From Not to Hot,” which will ... TV notable, “Mama” June Shannon, known to millions from the 2012 reality television series, ...
(Date:2/23/2017)... ... ... Dr. David Mahon leads Siena Dental, a comprehensive dental practice located at ... Top Patient Rated Henderson Dentist by Find Local Doctors earlier this year. ... dentists who have earned high ratings and superior patient reviews from multiple credible sources. ...
(Date:2/23/2017)... ... 2017 , ... The Center for Autism and Related Disorders ... Research and Treatment (RI-CART) and Cinemaworld to present Sensory Friendly Films. The events ... films in an environment that accommodates their unique needs. , Launched in January, ...
Breaking Medicine News(10 mins):