Navigation Links
Kemwell Announces Successful Pre-NDA US FDA Inspection
Date:1/31/2013

BANGALORE, January 31, 2013 /PRNewswire/ --

Kemwell Biopharma Pvt. Ltd., a global pharmaceutical contract development and manufacturing company, announced today that its Oral Solids manufacturing facility located in Bangalore, India has successfully completed a U.S. Food and Drug Administration (USFDA) inspection. The cGMP Audit for a Pre-Approval Inspection (PAI) was triggered by an NDA filing by one of the top ten global pharmaceutical companies. Kemwell has manufactured numerous products for the European markets for top pharmaceutical companies. This project is part of a growing effort to serve the US market.

"The approval from the US FDA confirms Kemwell's cGMP manufacturing capability and regulatory compliance, and our commitment to provide our customers the highest standards of quality. The facility has been approved by many global regulatory authorities including EMA, MHRA, Health Canada and TGA. We will continue to strive to provide excellent quality pharmaceutical products and deliver on the highest customer service expectations," says Anurag Bagaria , Chairman and Managing Director, Kemwell Biopharma.

Applying Quality by Design (QbD) principles, Kemwell's R&D and manufacturing teams in conjunction with the customer, optimized tablet formulation, conducted process scale-up studies to define design space for manufacturing of tablet formulation, and manufactured the validation and submission batches for this NDA filing. The audit involved an in-depth review and evaluation of all systems, procedures and processes related to the development, validation and manufacture of oral solids at the Bangalore site.

The state-of-the-art facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility has been built-in with high flexibility to manage batch sizes from 10kg
'/>"/>

SOURCE Kemwell Biopharma Pvt Ltd
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
2. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
3. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
4. Misonix Announces New Distribution Agreement For Panama
5. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
6. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
7. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
8. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
9. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. STAAR Surgical Announces First Quarter 2012 Results Release Date and Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... , Dec. 15, 2014  Colorado and ... have legalized adult use of cannabis. Oregon ... D.C. ended prohibition during the November 2014 elections. ... Photo - http://photos.prnewswire.com/prnh/20141212/164153LOGO The benefits ... noted and obvious benefits like the increased tax revenue for ...
(Date:12/15/2014)... 2014   DaVita HealthCare Partners Inc.  (NYSE: ... largest and most innovative health care communities, today ... DaVita Clinical Research  (DCR) and  HealthCare Partners Clinical Research ... extensive clinical research and data analytics services, specifically ... end-stage renal disease (ESRD), as well as primary ...
(Date:12/13/2014)... 11, 2014 Research and Markets ... the "Drug Injection Devices to 2020" ... http://photos.prnewswire.com/prnh/20130307/600769 As new drugs ... list of health conditions, drug developers have increasingly ... administration process and increase the efficiency and reliability ...
Breaking Medicine Technology:CannaInsider.com Estimates 200,000 New Jobs in the Cannabis Industry by 2015 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 3DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 4Drug Injection Devices to 2020 2Drug Injection Devices to 2020 3Drug Injection Devices to 2020 4
... ( US HIFU ), a world leader in minimally invasive ... ) technologies and manufacturer of the Sonablate® 500 medical device ... available to prostate cancer patients for the first ... Curitiba, capital city of the state of Parana in southern ...
... Medical, Inc. ("Kips Bay"), a development stage medical device ... vein support technology, or eSVS MESH, for use in ... it has closed its previously announced offering of 2,062,500 ... $8.00 per share.   Kips Bay ...
Cached Medicine Technology:Sonablate® HIFU for Prostate Cancer in New Locations Outside the U.S. 2Sonablate® HIFU for Prostate Cancer in New Locations Outside the U.S. 3Sonablate® HIFU for Prostate Cancer in New Locations Outside the U.S. 4Kips Bay Medical Announces Closing of its $16.5 Million Initial Public Offering of Common Stock 2
(Date:12/15/2014)... Cancer researchers have just published an important new report ... pleural mesothelioma. Surviving Mesothelioma has just posted an article ... to read it now. , Doctors at Harvard, ... York’s Langone Medical Center performed complete genetic analyses on ... effort to pinpoint the genes that are most likely ...
(Date:12/15/2014)... SIMpalm, a leading mobile app development company , ... client, which allows users to keep track of wines ... the right wine. At the center of WineMatch ... and wine information. All this information is assembled to ... that are close counterparts to one another are called ...
(Date:12/15/2014)... 14, 2014 (HealthDay News) -- Expert pilots process visual ... why they make better decisions during landings, a new ... difficult techniques for pilots to master, and 36 percent ... crashes occur during final approach and landing. Researchers ... 12 moderately experienced pilots while they were at the ...
(Date:12/15/2014)... In support of high-quality independent peer ... state laws that may have unintended consequences through ... of public health policy. , The position paper, ... Independent Review, contends that state legislation that restricts ... determinations can result in subpar outcomes for both ...
(Date:12/15/2014)... For the second year in a row, Bird Rock ... 2014.” Bird Rock Coffee Roasters’ Sumatra Ulos Batak came in ... 10. This is the first year that any roaster made ... on quality, value, and other aspects, including certifications and distinct ... and at $17.99 for 12-ounces, was also the most affordable ...
Breaking Medicine News(10 mins):Health News:New Study Reveals Genetic Mutations That May Trigger Mesothelioma, According to Surviving Mesothelioma 2Health News:Use WinMatch Connect App to Keep Track of Wines You Like 2Health News:Study Shows Why Expert Pilots Are Experts 2Health News:NAIRO Calls for Higher Quality Independent Peer Review By Ending Restrictive State Laws 2Health News:Bird Rock Coffee Roasters Ranks Second and Tenth in Coffee Review’s ‘Top 30 Coffees of 2014’ 2
... Calif., March 26 Endocare, Inc.,(Nasdaq: ENDO ), ... minimally invasive technologies for tissue and tumor,ablation, today announced ... the B. Riley & Co. 9th Annual Las Vegas ... Friday, April 4, 2008. The conference is,being held at ...
... CAMPAIGN KICKS OFF TODAY, LOS ANGELES, March 26 ... the American Academy of Neurology,(AAN), the American College of ... is raising awareness about the warning signs,of stroke and ... a campaign called "Give Me 5: Walk, Talk, Reach, ...
... LOUIS, March 25 KV Pharmaceutical Company,(NYSE: ... that,develops, manufactures, acquires and markets technology differentiated,branded ... of its fiscal 2007 Form 10-K with ... includes restatements of previously reported results for,fiscal ...
... 25 As Americans get a "wake-up call",about ... men with type 2,diabetes to know that they ... men., Listen to this report from Solvay ... access video, audio, text, graphics and,photos for free ...
... March 25 Author and Patient,Advocate Teri Robert ... --,she,s been experiencing headaches and migraine attacks herself ... help those in,the migraine community, Robert, in conjunction ... the launch of the,"Putting Our Heads Together" Poetry ...
... COLUMBUS, Ohio A new study reviewing 75 group-randomized ... than half of those studies used appropriate statistical methods ... trials may have reported that interventions to prevent disease ... they might not have been. , More than a ...
Cached Medicine News:Health News:Endocare to Present at the B. Riley & Co. 9th Annual Las Vegas Investor Conference 2Health News:Morgan Fairchild Joins Neurologists, Emergency Physicians and the American Stroke Association to Educate the Public About Stroke Symptoms 2Health News:Morgan Fairchild Joins Neurologists, Emergency Physicians and the American Stroke Association to Educate the Public About Stroke Symptoms 3Health News:Morgan Fairchild Joins Neurologists, Emergency Physicians and the American Stroke Association to Educate the Public About Stroke Symptoms 4Health News:KV Pharmaceutical Company Completes Financial Restatement with the Filing of Fiscal 2007 Form 10-K 2Health News:KV Pharmaceutical Company Completes Financial Restatement with the Filing of Fiscal 2007 Form 10-K 3Health News:KV Pharmaceutical Company Completes Financial Restatement with the Filing of Fiscal 2007 Form 10-K 4Health News:MyMigraineConnection.com and Migraine Expert Teri Robert Announce Seventh Annual Migraine and Headache Poetry Contest 2Health News:MyMigraineConnection.com and Migraine Expert Teri Robert Announce Seventh Annual Migraine and Headache Poetry Contest 3Health News:Review of group-based cancer trials reveals flaws in studies' design and analysis 2Health News:Review of group-based cancer trials reveals flaws in studies' design and analysis 3
This cannula is flanged with radiopaque tip with 2 side holes....
This cannula features a PVC body, auto inflatable smooth cuff, pressure monitoring line with integral stopcock....
The KAVD Venous Cannula is the first of its kind. It is a combination of cannulae/venous line designed to "bridge the gap between the patient and the Medtronic Resting Heart System circuit....
The DLP Elongated One-Piece Arterial Cannulae features a longer body for easier access during conventional and minimally invasive procedures...
Medicine Products: