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Ranbaxy agreed to settle both the civil and criminal liabilities by paying a penalty related to conduct which occurred several years ago. Ranbaxy had two options; either to continue fighting with DOJ for years, under a cloud of uncertainty, or in the best interests of all of the company’s stakeholders, to bring the matter to a close through a voluntary settlement. In the best interests of our stakeholders, we decided to settle. 2. How is Ranbaxy as a company different today from the Ranbaxy that committed the crimes detailed in the United States Department of Justice filing? Since 2008, the company has appointed an entirely new Board of Directors, Executive Committee and management team. This new leadership is committed to integrity and professionalism and to ensuring that all Ranbaxy facilities, practices and principles meet the high standards that patients, prescribers and the public expect from a leading global generic pharmaceutical company. We are committed to our mission of ‘Enriching lives globally, with quality and affordable pharmaceuticals’. We have made significant enhancements in our systems, processes and manufacturing. We have also invested more than $300 million in infrastructure and plant upgrades, training and state-ofthe-art quality control systems. There is now greater transparency, collaboration and simplicity in operations which is key to the corporate culture at Ranbaxy today. We believe that our improvements are making a difference. Since 2009, the company has undergone more than 175 successful regulatory agency inspections across its global facilities. 3. It’s our understanding that Ranbaxy earned $1 billion from US sales of Ranbaxy drugs in 2012, is that accurate? What dollar amount of that $1 billion was manufactured overseas? In the USA, Ranbaxy recorded sales of $946 million in 2012. We are proud to be able to provide affordable drugs to patients in the United States. We don't release sales information based on the location of manufacture. 4. When did Ranbaxy first begin to officially begin selling products to the US market? Ranbaxy began marketing generic products in the US in 1998 after receiving the first U.S. Food and Drug Administration approval for Cefaclor, a broad-spectrum anti-infective agent. 5. In 2004 the World Health Organization recalled three AIDS Ranbaxy drugs because they could not prove the drugs were the same as the brand name, can you comment on this? In November 2004, Ranbaxy informed the World Health Organization (WHO) that it was voluntarily withdrawing all the product dossiers under assessment and all prequalified products of its antiretrovirals. This action was taken after the company found discrepancies in the documentation provided by an independent non-affiliated company with which Ranbaxy had
contracted to provide testing relating to proof of the products' bioequivalence with originator medicines. Ranbaxy was one of several companies that were forced to repeat testing because of the problems with this third party contractor. 6. It has been reported that Ranbaxy made $500 million on the first six months of exclusivity for generic Lipitor, please confirm. We do not disclose product specific revenues. However, Atorvastatin, the generic version of Lipitor, was a successful product because it is widely prescribed and no other generic was available at that time. 7. What is your reaction to the U.S. FDA import alert announced this week? While we are disappointed that FDA took this step, Ranbaxy will continue to fully cooperate with the US FDA and take all necessary steps to resolve the FDA concerns. No drugs were being shipped to the U.S. from the facility that was subject to the import alert, and no drugs from this facility will be shipped to the U.S. until FDA’s concerns are resolved. Ranbaxy remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company. Ranbaxy stays firmly committed to its philosophy of ‘Quality and Patients First’. 8. Does the API manufactured in Toansa end up in drugs for sale in the United States? At this point does Ranbaxy manufacture any drugs or API overseas for the US market? If so, out of what Ranbaxy facility and where are they made? Ranbaxy manufactures all drugs for the U.S. in the U.S. It buys ingredients used in making those drugs from various locations, including its Taonsa facility. Thus, drug ingredients from Taonsa are used for making some drugs for the US after they are tested in the U.S. Ranbaxy does not buy ingredients for making drugs for the U.S. at any other Ranbaxy facility. 9. Does this latest import alert mean Ranbaxy loses a billion dollars in sales? As mentioned earlier, products sold in the US are manufactured at our Ohm facility, located in the US. No products are being shipped to the US from the Mohali facility. We do not expect any immediate financial impact of the import alert. 10. In a recent Ranbaxy town hall, Mr. Arun Sawhney said “Does it mean that our drugs were substandard? And the clear answer is no. Does this mean that our drugs were contaminated? And again in our minds the clear answer is an emphatic, no.” But in the United States Department of Justice plea , Ranbaxy pled guilty to producing adulterated drugs. Does Mr. Sawhney and Ranbaxy now dispute that Ranbaxy produced adulterated drugs for the US market?
The definition of ‘adulteration’ in the US and Indian context is quite different. In the US, if the company is not compliant with cGMP, any medicines that it manufacturers are considered to be adulterated under the law which is not the case in India. In India the word ‘adulteration’ may connote spurious/contaminated/sub-standard. Mr. Sawhney's comment at the Ranbaxy town hall must be understood in this context of Indian audience who are conversant with the Indian Laws. Mr. Sawhney commented on the efficacy and safety and did not dispute Ranbaxy’s admitted position in US under the US Laws. USFDA has in the past and also in their Press Release of September 16, 2013 recommends that the patients not disrupt their drug therapy because this could jeopardize their health. 11. Your critics point to the latest U.S. FDA 483’s and the latest import alert on Mohali and say that Ranbaxy has continued the same pattern that led to the company pleading guilty to selling adulterated drugs. How do you respond? While we are disappointed with the recent turn of events, we will work closely with FDA on remediating the issues at Mohali facility and will take all measures to keep our facilities in full compliance to all regulations. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect. The Company believes that it has made further improvements at its Mohali facility since the last inspection in 2012, and remains committed to addressing all concerns of the US FDA. Ranbaxy is hopeful of an early resolution of these concerns.” 12. What message would you send to an American audience about the safety of drugs produced by Ranbaxy? We would like the public to know that Ranbaxy is committed to providing high quality affordable drugs to patients in the US and we are proud to be able to serve the public of the United States. We hope to be able to expand our product offerings in the US in the future. USFDA has in the past and also in their Press Release of September 16, 2013 recommends that the patients not disrupt their drug therapy because this could jeopardize their health. We have made a significant investment in the US for manufacturing and product development, and have close to 600 people working in the US and approximately 520 people in our manufacturing facilities in NJ. 13. In the Toansa facility, glass particles were recently found in machines producing API’s for generic Lipitor. And according to 483 documents from the U.S. FDA, the facility had numerous problems, including failure to investigate problems, inaccurate manufacturing records, sampling plans "not scientifically sound". How do you respond to critics who say these events are the same pattern of problems that led to Ranbaxy pleading guilty in a U.S. federal court?
While we are disappointed with the recent turn of events, we will work closely with FDA on remediating and will take all measures to keep our facilities in full compliance to all regulations. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect. We are working with some of the leading industry cGMP consultants to ensure our manufacturing practices meet our own and regulator’s high expectations. Our goal is to continuously improve practices at our facilities. Like all pharmaceutical companies we undergo routine inspections by the regulators who oversee our operations. In fact, Ranbaxy has undergone more than 175 successful regulatory inspections at our facilities in the last three years. During these inspections, regulators, including FDA, visit our plants and seek information about our products. It is quite usual for pharmaceutical plants to undergo inspections in which there are observations from regulators, and companies respond to those observations.