Mumbai: Pharma Major Lupin Limited (Lupin) announced today that it has received notification that the inspection carried out by the US FDA in March 2016 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR). This closes all outstanding US FDA inspections at Lupin’s Goa facility.
Commenting on the receipt of the EIR, Vinita Gupta, Chief Executive Officer and Nilesh Gupta, Managing Director, Lupin said “We are committed to ensuring that all systems and processes followed by Lupin are compliant with cGMP and are committed to bringing quality products to market. We are grateful for the US FDA’s confidence in our corrective action plan and in our team. It is our goal to remain well ahead on the compliance curve”.
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 5th and the 7th largest generics pharmaceutical company by market capitalization and sales globally (June 30th, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.68% market share – IMS Health, National Prescription Audit, March 2016); the 3rd largest Indian pharmaceutical company by revenues; the 6th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).
For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs. 136,539 million (USD 2.09 billion) and Rs. 22,607 million (USD 345 million) respectively. Please visit http://www.lupin.com for more information.
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CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
Head – Corporate Communications
Ph: +91 98 20 338 555