MUMBAI, India, Jan. 20 Pharma major, Lupin Ltd announced today that it has received official communication from the US FDA on the satisfactory resolution of the Warning Letter issued earlier to its Mandideep site. The company had received a Warning letter for its Mandideep site in May 2009. In the ensuing seven months, the company made significant enhancements and took appropriate corrective actions. The facility was re-inspected in November 2009 and the company was able to satisfactorily address all of the concerns related to the Warning Letter and the site compliance status was found to be acceptable.
In the last quarter, the FDA inspected two new sites of the Company at Aurangabad (Liquids) & Indore (Oral Solids and Oral Contraceptives). Aurangabad was found acceptable with no 483's and Indore was found acceptable with one 483 observation which was satisfactorily addressed before the close of the inspection. These recent successful inspections bring the company a step closer to launching liquids and Oral Contraceptives.
Earlier, the UK MHRA and the Australian TGA had also conducted a joint inspection of the Mandideep facility and had found it acceptable.
Speaking of the inspections, Nilesh Gupta, Group President and Executive Director, said, "We are very pleased that we have been able to satisfactorily address the US FDA's concerns and clear the status of Mandideep. We are very proud that our people have been able to make this happen. This achievement is even more commendable in the current heightened regulatory environment and is strong testimony of how we are moving up the regulatory curve. With the recent inspections and satisfactory resolution of all pending concerns at Mandideep, all our facilities have now been inspected in the past year and have been found to be in good shape."
Headquartered in Mumbai, India, Lupin Ltd (BSE: 500257; NSE: Lupin; REUTERS: LUPN.BO; BLOOMBERG: LPC IN) is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company today has significant market share in key markets in the Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not to mention global leadership positions in the Anti-TB and Cephalosporins. The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
Our Drugs and products reach over 70 countries in the world. Today, Lupin has the unique distinction of being the fastest growing top 10 Generics players in the two largest pharmaceutical markets of the world - the US (ranked 9th by prescriptions & growing at 92%) and Japan (ranked 7th and growing at 23%). The company is also the fastest growing, top 5 pharmaceutical players in India (ORG IMS - March 2009) and the fastest growing Generic player in South Africa (ranked 6th and growing at over 30% YoY - IMS)
For the financial year ended March 2009, Lupin's Consolidated Revenues and Profit after Tax were Rs. 39,145 million (US$ 851 million) and Rs. 5015 million (US$ 109 million) respectively. Please visit http://www.lupinworld.com for more information about Lupin Ltd.
Lupin Pharmaceuticals, Inc. is the US wholly owned subsidiary of Lupin Ltd. Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.
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SOURCE Lupin Ltd