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

0

GOOD

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:5/23/2013)... EDGE, N.J. , May 23, 2013 ... a commercial stage medical device company that develops and ... successful completion of its rights offering.  In addition, the ... March 2011 warrants expired on May 17, 2013. ... of $3.0 million from the rights offering.   A portion ...
(Date:5/23/2013)... 2013  TeamHealth Medical Call Center (THMCC), a ... advice lines, announces its newly formed Clinical Advisory ... administrative leaders, provides clinical expertise to advance THMCC,s ... for hospital clients, physician clients and patients. ... it,s imperative to continuously advance our services and ...
(Date:5/23/2013)... MONICA, Calif. , May 23, 2013 ... a program that would have required them to obtain ... today by Consumer Watchdog and Whatley Kallas LLC.  ... Diego Superior Court, alleged that Blue Cross,s mandatory mail ... patients, threatening their health and privacy. "This ...
Breaking Medicine Technology:Nephros Announces Completion of Rights Offering 2Nephros Announces Completion of Rights Offering 3Nephros Announces Completion of Rights Offering 4TeamHealth Medical Call Center Forms Clinical Advisory Committee 2Blue Cross To Allow HIV/AIDS Patients to "Opt-Out" of Mandatory Mail-Order Rx Drug Program, Announces Consumer Watchdog 2Blue Cross To Allow HIV/AIDS Patients to "Opt-Out" of Mandatory Mail-Order Rx Drug Program, Announces Consumer Watchdog 3
... -- Metabasis,Therapeutics, Inc. announced today that a poster ... Tolerability and Pharmacokinetics,(PK) of Intravenous (IV) Infusion of ... be presented at,the 2007 annual meeting of the ... CA. The presentation will take,place on April 16, ...
... A study comparing,the formulations of isosorbide dinitrate (ISDN) ... II, and BiDil, the proprietary,fixed dose combination, used ... no bioequivalence. Non-bioequivalence,in the formulations used may explain ... results in decreasing mortality. Using,identical amounts of active ...
Cached Medicine Technology:Metabasis Therapeutics to Present Poster at American Association,for Cancer Research 2Study: Identical Doses of BiDil Components Are Not Bioequivalent to,the Fixed Dose Combination-BiDil-Used in A-HeFT 2Study: Identical Doses of BiDil Components Are Not Bioequivalent to,the Fixed Dose Combination-BiDil-Used in A-HeFT 3Study: Identical Doses of BiDil Components Are Not Bioequivalent to,the Fixed Dose Combination-BiDil-Used in A-HeFT 4Study: Identical Doses of BiDil Components Are Not Bioequivalent to,the Fixed Dose Combination-BiDil-Used in A-HeFT 5
(Date:5/24/2013)... respected Alzheimer,s researchers failed to replicate what appeared to ... disease when they were published last year in the ... Feb. 9, 2012, suggested that the drug bexarotene (marketed ... amyloid plaques (Aβ) a pathological hallmark of Alzheimer,s ... the authors of the 2012 report, drug treatment quickly ...
(Date:5/24/2013)... Salt Lake City, Utah (PRWEB) May 24, 2013 ... AnatomyOne 2.0 , with exciting new enhancements for instructors ... help students stay more focused through personalize learning plan ... the new AnatomyOne release provides 500 new assessment questions, ... make and review notes. , AnatomyOne 2.0 ...
(Date:5/24/2013)... 24, 2013 Mr. Brian Su, CEO ... Annual EB-5 Investment Summit: Dealmakers Conference in Long Beach, ... focus on exploring alternative finance through EB-5 immigrant investors ... and economic information, and updates to project developers, regional ... industry. , "Our goal is to assist EB-5 ...
(Date:5/24/2013)... York, NY (PRWEB) May 24, 2013 ... Yahoo Commerce VP, Brandon Huff as Executive Vice President ... its commerce business units, which represented a large portion ... lead digital growth as Dwell develops a fully-integrated commerce ... a decade of experience monetizing digital content for leading ...
(Date:5/24/2013)... Stoler believes that there is much to be learned ... That’s why he hosts “Building New York—New York ... that’s why he invited Robert Glazer, Chief Executive Officer ... specialty practice in the greater New York area, whose ... sub-specialists service communities throughout New York and New Jersey ...
Breaking Medicine News(10 mins):Health News:Multiple research teams unable to confirm high-profile Alzheimer's study 2Health News:Multiple research teams unable to confirm high-profile Alzheimer's study 3Health News:Amirsys AnatomyOne 2.0 Delivers Personalized Learning Plans 2Health News:Brian Su Organizes 3rd Annual EB-5 Investment Conference in Long Beach, California 2Health News:Yahoo Commerce Head Joins Leadership at Dwell Media 2Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 2Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 3Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 4
... funding source to public health , ... Prevention today unveiled health reform recommendations to Congress that ... tackle the chronic diseases that are causing medical costs ... Under these proposals, federally funded insurance programs would provide ...
... Karmanos, Work It Out (DKWIO), a,dynamic 501(c)(3) not-for-profit program ... today announced that Tracey Secco has joined,DKWIO as Director ... ten years,of experience in public relations and program management ... organization,s life-changing message. , ...
... Dec. 11 PURE Bioscience,(Nasdaq: PURE ), ... reported revenues for the fiscal quarter ended October,31, 2008 ... same quarter,last year. The Company reported a loss ... for the current quarter compared with a,loss of $(1,008,700), ...
... beta agonists may cause asthma problems and death, agency ... safety of four asthma medications will be weighed by a ... of hearings end Thursday. , The controversy over these drugs ... officials recently calling for banning the use of these drugs ...
... in Pennsylvania to open store in Mechanicsburg,s , ... CAMP HILL, Pa., Dec. 11 As individuals and seniors ... and small business owners look for health plan options, Highmark ... health insurer in the state to open a health insurance ...
... and founder of Allergy & Asthma Network Mothers of ... access to all forms of 12-hour bronchodilators at a ... Safety and Risk Management Advisory Committee and Pediatric Advisory ... Rockville, MD. , , ...
Cached Medicine News:Health News:Partnership for Prevention Offers Health Reform Recommendations to Congress 2Health News:Partnership for Prevention Offers Health Reform Recommendations to Congress 3Health News:Danialle Karmanos' Work It Out Names Tracey Secco as Director of Operations 2Health News:PURE Bioscience Reports First Quarter Results 2Health News:PURE Bioscience Reports First Quarter Results 3Health News:PURE Bioscience Reports First Quarter Results 4Health News:PURE Bioscience Reports First Quarter Results 5Health News:PURE Bioscience Reports First Quarter Results 6Health News:FDA Panel Mulls Safety of Asthma Meds 2Health News:FDA Panel Mulls Safety of Asthma Meds 3Health News:Highmark Blue Shield to Open 'Highmark Direct,' a Health Insurance Retail Store 2Health News:Highmark Blue Shield to Open 'Highmark Direct,' a Health Insurance Retail Store 3Health News:AANMA Provides Commentary to FDA Advisory Committees Reviewing Benefit-Risk Assessment of 12 Hour Bronchodilators 2
Adjustable piston accommodates 7-9mm trephine blade. Complete punch includes base plate, piston carrier, piston for 7 - 9mm trephine blades and 18mm diameter Teflon block. Designed for accurate donor...
... German Craftsmanship have produced ... in the world. Ocutek® ... to you! Only holders ... certificate, which requires and ...
... of German Craftsmanship have ... instrumentation in the world. ... available to you! Only ... Meisterbrief certificate, which requires ...
... of German Craftsmanship have ... instrumentation in the world. ... available to you! Only ... Meisterbrief certificate, which requires ...
Medicine Products: