Ranbaxy Announces Improved Business Standards and Quality Assurance Initiatives

Ranbaxy Announces Improved Business Standards and Quality Assurance Initiatives 



Tokyo, Japan (May 22, 2013) – Ranbaxy Laboratories Limited (hereafter, Ranbaxy), a subsidiary of Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo), today announced via the attached press release of the actions that Ranbaxy has taken in recent years to address past conduct under prior management.
 
Daiichi Sankyo continues to support Ranbaxy in its efforts to address and correct the conduct of the past which led to the investigations by the U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("USFDA"). These efforts include significant changes to Ranbaxy's management, culture, operations and compliance.
 
Daiichi Sankyo believes that certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the U.S. DOJ and FDA investigations. Daiichi Sankyo is currently pursuing its available legal remedies and cannot comment further on the subject at this time.
 

RANBAXY HIGHLIGHTS IMPROVED BUSINESS AND QUALITY ASSURANCE STANDARDS

May 22, 2013:

DEDICATED TO PROVIDING SAFE AND EFFICACIOUS MEDICINES GLOBALLY

Gurgaon, India, May 22, 2013: Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) ("Ranbaxy") today highlighted some of the major specific actions the Company has been taking in recent years to address certain conduct of the past and to ensure the safety and efficacy of all Ranbaxy products currently available in the global market. These actions include:

Arun Sawhney, CEO & Managing Director, Ranbaxy, stated, "Ranbaxy is a different company today. The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect."

Sawhney added, "All Ranbaxy products currently in the global market are safe and effective, and we remain focused on our philosophy of 'Quality and Patients First.' In the recent years we have made significant improvements in the way we conduct our business to ensure greater quality control and have made investments of over US$ 300 million in our manufacturing facilities to install state-of-the-art technologies. We have also instituted a rigorous new Code of Conduct for all Ranbaxy employees, with clear accountability for compliance."

Sawhney concluded, "Ranbaxy has successfully launched several new generic equivalents across the world recently, and maintains a robust pipeline of important new products as we look to build on our strong global portfolio of branded and generic prescription and OTC pharmaceuticals. We look forward to continuing to enrich lives globally with quality and affordable medicines."

ADDITIONAL INFORMATION

ENHANCEMENTS TO RANBAXY BUSINESS AND QUALITY ASSURANCE STANDARDS

Management and Governance

Reconstituted the Board of Directors and executive management team since the acquisition of a majority stake in Ranbaxy by Daiichi Sankyo in 2008. The new team is committed to building and maintaining a culture of accountability, steadfast regulatory adherence and continuous improvement in quality across all levels of the organization.

  • The reconstituted Board of Directors comprises four independent directors with no previous ties to Ranbaxy, three senior executives from the Daiichi Sankyo group and the current Ranbaxy CEO & Managing Director.
  • Ranbaxy executive management team was reconstituted with several executives from outside the Company, including the current CEO & Managing Director, Arun Sawhney, who joined Ranbaxy in 2008, was appointed in his current position in 2010.
  • The Company Appointed, in 2009, the former Executive Director, Quality Assurance of Daiichi Sankyo USA, Mr. Dale Adkisson, as Head of Global Quality at Ranbaxy.
  • The Company established a new executive management position of Chief Data Reliability Officer as agreed with the US FDA under its Consent Decree.

Compliance

Ranbaxy manufacturing facilities in India and other parts of the world are routinely inspected by leading global regulatory agencies. Since 2009, the Company has undergone more than 175 regulatory agency inspections across its global facilities.

Additionally for USA, in January 2012, Ranbaxy entered into a consent decree with the U.S. Food and Drug Administration ("FDA") to further strengthen procedures and policies to ensure data integrity and to comply with Current Good Manufacturing Practices ("cGMP"). Ranbaxy has engaged the best in class consultants as Data Integrity and cGMP Experts to fulfill the requirements of the consent decree.

The above measures will continue to significantly benefit Ranbaxy's global business operations.

Business and Manufacturing Processes

As Ranbaxy continues to ensure ongoing regulatory compliances, it has implemented the following upgrades to and investments in its business and manufacturing processes globally:

Accountability

Ranbaxy noted that the elements above are not assumed to be comprehensive, and that the Company is committed to building a culture of employee accountability at both the individual and corporate level.

In keeping with that effort the Company has:

About Ranbaxy Laboratories Limited

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe. For more information, please visitwww.ranbaxy.com.

 

Suggested Articles

The efficacy between Keytruda and FerGene's nadofaragene firadenovec look comparable in their studies, though Merck has at least one upper hand.

Thursday, the FDA approved the first three generic versions of Gilenya, but they may not hit the market anytime soon due to ongoing litigation.

Gilead is hoping to score a patent extension on TAF meds, but patient advocates say that would reward conduct that harmed patients.