医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Kemwell announces successful USFDA inspection

2015年03月24日 PM09:48
このエントリーをはてなブックマークに追加


 

BANGALORE, India

Kemwell Biopharma Pvt. Ltd., a global bio/pharmaceutical contract development and manufacturing company, announced today that its oral solids manufacturing facility located in Bangalore, India has successfully completed its second U.S. Food and Drug Administration (USFDA) inspection. This audit took place for an ANDA filed for a customer.

On completion of the inspection, the USFDA inspector concluded that the facility, systems and practices comply with USFDA requirements and no observations were reported on Form 483.

“Kemwell’s team is proud of the results of the FDA inspection. This success is testament to our ongoing commitment towards our quality systems. We continue to leverage our 30-year experience in being a leading CDMO to provide our customers with cost-effective solutions at high quality standards,” says Anurag Bagaria, Chairman and Managing Director.

The state-of-the-art oral solids facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility has high flexibility built-in to manage batch sizes ranging from 10kg to 1000kg. Kemwell has been regularly shipping products to Europe, Australia, Canada and USA from this facility.

About Kemwell:

Kemwell Biopharma is a 100% CDMO that provides customized product development and cGMP compliant manufacturing solutions to pharmaceutical and biopharmaceutical organizations worldwide. With integrated facilities in India, US and Sweden, Kemwell delivers a comprehensive portfolio of services for sterile and non-sterile products from preformulation to commercial supply. Kemwell facilities are approved by USFDA, EMA, HC and PMDA.

Kemwell services over 100 global bio/ pharmaceutical companies, including 7 of the top 10 Big Pharma. Founded in 1980, Kemwell employs 1200 people, has 10 facilities worldwide and supplies to 80 countries globally.

Read more about Kemwell on www.kemwellbiopharma.com.

CONTACT

Kemwell Biopharma Pvt. Ltd.
Karan Bagaria, +91-80-39285450
VP
Corporate Development
karan.bagaria@kemwellpharma.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • Philip Morris International Launches Next Generation of IQOS, the World’s Leading Heated Tobacco Product
  • PotNetwork Holdings, Inc.第三季度业绩创纪录,营收超过610万美元
  • ポットネットワーク・ホールディングスが610万ドルを超える収益で過去最高の第3四半期を終える
  • ポットネットワーク・ホールディングスがSEC報告会社となるためにフォーム10を提出
  • Sinovac Granted Interim Injunctive Relief Regarding Filings Bearing a Falsified Company Seal and Forged Board Member Signatures