News

Article

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-03-01-2017
Volume12
Issue 3

Kemwell Announces Successful FDA Inspection at Bangalore Facility

Author(s):

Pharmaceutical Technology Editors

The company announced that no Form 483 was observed at the company’s facility in Bangalore, India.

On Feb. 20, 2017, Kemwell Biopharma announced that its oral solids manufacturing facility in Bangalore, India successfully completed an FDA inspection. The inspection confirmed that the site is compliant with principles of current good manufacturing practices and no Form 483 observations were issued. In a statement, the company said the audit was triggered by an abbreviated new drug application filed for a customer. This facility is part of Kemwell’s pharmaceutical business for which Kemwell has signed a purchase agreement with Recipharm.

Source: Kemwell

Articles in this issue
Viewpoint: No Clear Path for Pharma or Outsourcing
Standards Set Excipient GMPs, But Collaboration is Needed
Standards Set Excipient GMPs, But Collaboration is Needed
Mass Spectrometry Measures Up to Biologics Drug Analytical Challenges
Mass Spectrometry Measures Up to Biologics Drug Analytical Challenges
Monitoring Supply Chain Risk on a Limited Budget
Monitoring Supply Chain Risk on a Limited Budget
Evaluating E&L Studies for Single-Use Systems
Evaluating E&L Studies for Single-Use Systems
PfizerCentreOne Expands Fill/Finish Services in Michigan
Metrohm USA Announces Winner of Young Chemist Award
Novasep Opens New Bioconjugation Unit in France
Kemwell Announces Successful FDA Inspection at Bangalore Facility
Abzena Signs Antibody Manufacturing Development Agreement with UCL
Recipharm Completes Kemwell Acquisition
Sartorius and the European Molecular Biology Laboratory Collaborate on Training
SGS Adds to ICP-MS Capabilities
Catalent Completes Accucaps Acquisition
FDA Warns India API Manufacturer Over Contamination Issues

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
July 25th 2025

EMA Approves Lower GWP Alternative for Inhalation Medicine

Susan Haigney
The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Sand running through the bulbs of an hourglass | Image Credit: © BillionPhotos.com - stock.adobe.com
July 24th 2025

Customizable Relationships Enhance Speed to Market

Patrick Lavery
While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023

Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain

Jill Murphy
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com
July 23rd 2025

ICH Q12 and Post-Approval Changes–Less than Satisfactory State of Affairs

Siegfried Schmitt
Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
Magnifier with pills on blue background | Image Credit: © Pixel-Shot - stock.adobe.com
July 23rd 2025

Overcoming PK/PD Modeling Challenges

Cynthia A. Challener
Artificial intelligence and machine learning can help identify complex patterns.