Navigation Links
Kemwell Announces Successful Pre-NDA US FDA Inspection

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

Primary Media Contact: Karan Bagaria ,, 91-80-39286200

Secondary Media Contact: Bhaskar Vishwanathan ,, 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:
(Date:12/1/2015)... -- ) has announced ... Market 2015 - Forecast to 2020" report ... has announced the addition of the "Drug ... report to their offering. --> ... the addition of the "Drug Delivery Technology ...
(Date:12/1/2015)... Sweden , December 1, 2015 ... Cancer Study Group (IBCSG, Bern ) and ... to be part of a state of the art trial, ... --> --> The study, ... treated with anti-hormonal therapy in combination with palbociclib, a cancer ...
(Date:11/30/2015)... BASEL, Switzerland , Dec. 1, 2015 /PRNewswire/ ... its wholly-owned UK subsidiary Proximagen Ltd., today announced a ... oral small molecule inhibitor of Vascular Adhesion Protein 1 ... the treatment of inflammatory disease. The VAP-1 inhibitor is ... --> --> Under the terms of ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... For the ... is why Hollister Incorporated has launched the VaPro Plus Pocket™ touch free hydrophilic ... the VaPro touch free catheter portfolio,” said Michael Gresavage, Vice President North America. ...
(Date:12/1/2015)... ... ... McLean, VA., December 1, 2015 - Octo Consulting Group, ... development contract to support the National Geospatial-Intelligence Agency's (NGA) IT Services Directorate. ... as well as operations and sustainment support to the NGA’s Agile Web Presence ...
(Date:12/1/2015)... ... ... XTC Semifinals 2016 - CES, Las Vegas, Nevada - Extreme ... 2016, the world’s largest Consumer Electronic Show, where they will present to a panel ... Pacific Investments Veronica Serra, and venture capitalist Tim Draper among many other top names ...
(Date:12/1/2015)... ... December 01, 2015 , ... Dr. Arash ... Modern Man for 2015. , Angeleno Magazine is a division of Modern ... in 1994, Modern Luxury includes more than 50 magazine titles across 15 major ...
(Date:11/30/2015)... ... 2015 , ... Olympic Gold Medalists and Celebrity Moms Dara ... various categories through traditional and social media marketing campaigns and other branding initiatives. ... Medal Moms who can connect with today’s most important consumer: mothers. In addition ...
Breaking Medicine News(10 mins):