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:2/8/2016)... FOSTER CITY, Calif., Feb. 8, 2016  Aoxing Pharmaceutical Company, Inc. ... of fiscal year 2016, ended December 31, 2015, the Company ... $6,430,701 recorded in the same quarter in fiscal 2015. ... income in Q2 of fiscal year 2016 was $2,068,635, or ... $567,169, or $.01 per share, in the Q2 of fiscal ...
(Date:2/8/2016)... ORLANDO, Fla. , Feb. 8, 2016 ... and marketing high performance apparel for healthcare and other ... Bold Chief Executive Officer. He replaces Dale ... and remains Chairman. Mr. Bold is also joining Vestagen,s ... in a new class of active barrier technologies that ...
(Date:2/8/2016)... Utah , Feb. 8, 2016  Dynatronics ... distributor of advanced-technology medical devices and rehabilitation equipment ... markets, congratulates the Denver Broncos, football team for ... H. Cullimore Jr. , Chairman and Chief Executive ... excellence and we look forward to enhancing their ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... Discover the Rocky Mountain region’s longest running ... 700 companies. Attendees also get to see the most incredible gardens and home ... Show , at the Colorado Convention Center - 700 14th St. Denver CO, is ...
(Date:2/8/2016)... KS (PRWEB) , ... February 08, 2016 , ... TopConsumerReviews.com ... leader in Mole removal products. , Moles are derived from a cluster of melanin ... in all the wrong places and create a lifetime of embarrassment. Historically, mole ...
(Date:2/8/2016)... ... , ... The schedule is now online for the largest and ... is being held May 25-29 at the Loews Chicago O’Hare Hotel, continues to give ... of chronic illness in children. , Very recent articles have cited 1 child in ...
(Date:2/7/2016)... , ... February 07, 2016 , ... Women's Excellence staff, ... Wear Red Day. National Wear Red Day is the first Friday each February ... disease and stroke cause 1 in 3 deaths among women each year – more ...
(Date:2/6/2016)... ... February 06, 2016 , ... ... 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , WHAT: ... world with an estimated 5000 perioperative nurses in attendance to study the ...
Breaking Medicine News(10 mins):