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 to 1000kg. Kemwell has been regularly shipping products to Europe and Australia from this facility, and will now soon start commercial supplies to Canada and USA.

About Kemwell Biopharma:

Kemwell Biopharma Pvt. Ltd., headquartered in Bangalore, India, is a pure-play global contract development and manufacturing company. The company manufactures pharmaceuticals for some of the world's top pharmaceutical companies, including GlaxoSmithKline, Bayer, Novartis and Pfizer. Kemwell is one of India's largest contract manufacturers of pharmaceuticals with over 30 years' experience. The company employs more than 1000 employees worldwide and has seven production facilities, five in India and two in Sweden. Kemwell is an approved pharmaceutical manufacturer in over 80 countries including the American, European, Japanese and Indian markets.

Read more about Kemwell on www.kemwellbiopharma.com.

Primary Media Contact: Karan Bagaria , karan.bagaria@kemwellpharma.com, 91-80-39286200

Secondary Media Contact: Bhaskar Vishwanathan , bhaskar.vishwanathan@kemwellpharma.com, 91-80-39286200


'/>"/>
SOURCE Kemwell Biopharma Pvt Ltd
Copyright©2012 PR Newswire.
All rights reserved

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:6/9/2017)... and INDIANAPOLIS , June 9, ... living with diabetes. In a further effort to help ... affected by this condition, the International Diabetes Federation (IDF) ... ) have come together for the second phase of ... Systems programme (BRIDGES 2), reaffirming their commitment to helping ...
(Date:6/7/2017)... GAITHERSBURG, Md. , June 7, 2017  Novavax, Inc., ... the second of two Phase 2 trials of its RSV ... women of child bearing age have been published in the ... this publication have been shared in prior scientific conferences). The ... trial in April 2014. Novavax is developing the RSV F ...
(Date:6/2/2017)... LAWRENCE, Mass. , June 2, 2017  NxStage ... advancing renal care, today announced new findings demonstrating positive ... NxStage ® System One™. The data will be ... 2017, in Madrid, Spain . ... Knowledge to Improve Home Dialysis Network in ...
Breaking Medicine Technology:
(Date:6/25/2017)... ... June 25, 2017 , ... June is Men’s Health Month and the ... common cancer among men in the U.S. and the third most common cause of cancer ... that one man in seven will be diagnosed with prostate cancer during his lifetime. ...
(Date:6/24/2017)... ... June 24, 2017 , ... The weather is heating ... outdoors. Home and business owners should be aware that the summer months provide more ... fact, mechanical locks and keys can be negatively affected from direct exposure to the ...
(Date:6/23/2017)... ... 23, 2017 , ... By scoring 100% for fiscal management and accountability, the ... online charity evaluator, Charity Navigator, validating ANRF's work as a top charity in America. ... Charity Navigator and earns ANRF a spot on their “ 10 Charities Worth Watching ...
(Date:6/23/2017)... ... June 23, 2017 , ... Dr. Ran Y. ... has recently begun offering three new minimally invasive procedures to patients who want ... reducing downtime, Dr. Rubinstein is excited to bring microneedling, microneedling facials, and platelet ...
(Date:6/23/2017)... ... ... The Aesthetic Channel has recently highlighted Dr. Ben Talei’s unique approach to ... technique that he calls the AuraLyft Facelift. The AuraLyft does more than ... expect to look refreshed, rejuvenated, and revitalized. , Dr. Talei’s unique approach stems ...
Breaking Medicine News(10 mins):