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:9/30/2014)... Sept. 30, 2014 CytRx Corporation (NASDAQ: ... development company specializing in oncology, today announced the ... evaluating aldoxorubicin compared to topotecan in subjects with ... relapsed or were refractory to prior chemotherapy. Aldoxorubicin ... agent, doxorubicin. CytRx has received Orphan Drug Designation ...
(Date:9/29/2014)... et SAN DIEGO , 29 ... (ci-après désignée Daiichi Sankyo) (TSE : 4568) et Ambit ... conclusion d,un accord de fusion définitif en vertu ... des actions ordinaires en circulation d,Ambit Biosciences à ... biais d,une offre publique d,achat qui sera suivie ...
(Date:9/29/2014)... , Sept. 29, 2014  Bob Pack, who lost ... called on the California Medical Association to immediately cease ... that the San Jose Mercury News called "shamelessly deceptive" ... it wants voters to believe about the measure is ... the Prop 46 requirement that doctors check ...
Breaking Medicine Technology:CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 2CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 3CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 4CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 5Daiichi Sankyo va acquérir Ambit Biosciences 2Daiichi Sankyo va acquérir Ambit Biosciences 3Daiichi Sankyo va acquérir Ambit Biosciences 4Daiichi Sankyo va acquérir Ambit Biosciences 5Daiichi Sankyo va acquérir Ambit Biosciences 6Daiichi Sankyo va acquérir Ambit Biosciences 7Daiichi Sankyo va acquérir Ambit Biosciences 8Daiichi Sankyo va acquérir Ambit Biosciences 9Father Calls On CA Medical Assn To Pull TV Ad Called "Jaw-Droppingly Deceptive" and "Baloney" By LA Times & "Shamelessly Deceptive" By San Jose Mercury News, Says Consumer Watchdog Campaign 2Father Calls On CA Medical Assn To Pull TV Ad Called "Jaw-Droppingly Deceptive" and "Baloney" By LA Times & "Shamelessly Deceptive" By San Jose Mercury News, Says Consumer Watchdog Campaign 3Father Calls On CA Medical Assn To Pull TV Ad Called "Jaw-Droppingly Deceptive" and "Baloney" By LA Times & "Shamelessly Deceptive" By San Jose Mercury News, Says Consumer Watchdog Campaign 4Father Calls On CA Medical Assn To Pull TV Ad Called "Jaw-Droppingly Deceptive" and "Baloney" By LA Times & "Shamelessly Deceptive" By San Jose Mercury News, Says Consumer Watchdog Campaign 5
(Date:9/30/2014)... York, New York (PRWEB) September 30, 2014 ... honor Kenro Izu – founder of the nonprofit, Friends ... on November 6, 2014, for building a hospital in ... pediatric care. , Izu first encountered Cambodia’s appalling ... from a variety of disabilities and illnesses during a ...
(Date:9/30/2014)... OH (PRWEB) September 30, 2014 ... blades sporting the iconic pink ribbon in support of ... a popular month for businesses and non-profits to “go ... worthwhile cause. , AutoTex PINK is a woman-owned company ... wipers. They are committed to partnering with their ...
(Date:9/30/2014)... September 30, 2014 Teeth replacement and ... Art Institute in Oxnard and Thousand Oaks, Calif., is ... tomorrow to provide training on full mouth rehabilitation. , ... placing implants, providing cosmetic dentistry, correcting bite issues, and ... , Dr. Jivraj, who has traveled to India to ...
(Date:9/30/2014)... 30, 2014 Loffler Companies, an ... technology and services was recognized by BEI as ... (FCE) in 2013. This prestigious rating means that ... time and for an extended period following, optimizing ... 20 years BEI Services has been the trusted ...
(Date:9/30/2014)... CA (PRWEB) September 30, 2014 In ... commemorate breast cancer survivors and their courageous battles, Incredible ... to start afresh with PicoSure® by Cynosure. , ... blue or black tattoo is applied on their skin ... explains Dr. Sam Ebrahimi. “For many survivors, they decide ...
Breaking Medicine News(10 mins):Health News:Nobel Prize For Child Advocates Announces 2014 Health Award Honoree 2Health News:Nobel Prize For Child Advocates Announces 2014 Health Award Honoree 3Health News:Change Your Blades … Change A Life! AutoTex PINK Wiper Blades Are Helping Wipe Out Breast Cancer 2Health News:Change Your Blades … Change A Life! AutoTex PINK Wiper Blades Are Helping Wipe Out Breast Cancer 3Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 2Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 3Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 4Health News:World-Renowned Dental Implant Expert, International Instructor in India Speaking about Reconstructive Dentistry 5Health News:Loffler Companies Rated Number One Among U.S. Dealers in Service “First Call Effectiveness” 2Health News:Loffler Companies Rated Number One Among U.S. Dealers in Service “First Call Effectiveness” 3Health News:Incredible Veins, Body & Skin Takes A Stand Against Breast Cancer With PicoSure® By Cynosure 2
... D.I.S.C. Spine and,Sports Center, proudly announces ... initial 18 months of operation where over ... Robert S. Bray Jr., founding director and,CEO. ... medical group,providing next generation diagnostics, conservative care, ...
... More than 500 hospital and supplier representatives expected ... all supply chain participants, LOUISVILLE, Colo., March ... will gather in Chicago, April 16-18 for the ... and identify opportunities,for greater collaboration to improve operational ...
... time of year when more,than 1.5 million high school and ... and drink large quantities of alcohol. Students who,vacation with friends ... who stay home with parents or relatives, according to a ... on Alcohol and Drugs., Instead of just telling students ...
... to help caregivers,maintain a sense of balance in their ... the focus of a recently published free Caregiver,s,guide. Today, ... and the free caregivers, guide will help them enhance ... guide provides caregivers with an easy-to-implement and inexpensive,way to ...
... Mich., March 25 Plexus Systems, Inc. ... about efficient manufacturing,operations on Thursday, March 27 ... entitled Smart Manufacturing! Manufacturing IQ & Manufacturing,Operations ... and best practices to achieve quality and ...
... family history are referred less often than whites, study finds ... is a family history of colon cancer, blacks are much ... a new study finds. , While blacks who have an ... their white counterparts in colonoscopy rates, the lack of a ...
Cached Medicine News:Health News:Zero Patient Infections Reported as D.I.S.C. Spine and Sports Center Sets New Standard for Specialty Hospitals 2Health News:The Healthcare Supply Chain to Connect in Chicago for the 2008 GHX Supply Chain Summit 2Health News:It's Spring Break: How Much Does Heavy Drinking Affect Your Body? 2Health News:Free Caregiver's Guide Helps Caregivers & Loved-Ones 2Health News:Plexus Systems, Inc. and Aberdeen Group Co-host March 27 Webinar on Manufacturing Efficiency 2Health News:Plexus Systems, Inc. and Aberdeen Group Co-host March 27 Webinar on Manufacturing Efficiency 3Health News:High-Risk Blacks Less Likely to Get Colonoscopies 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: