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Lupin announces closure of US FDA Audits for its Mandideep and Aurangabad Facilities

 

Mumbai, May 26, 2016: Pharma Major Lupin Limited (Lupin) announced today that it has received Establishment Inspection Reports (EIR) for its Mandideep and Aurangabad facilities wherein the US FDA has concluded that the inspections stand closed.

The US FDA had conducted audits at Lupin’s Mandideep facility from 8th to 19th February, 2016 and its Aurangabad facility from 11th to 15th January, 2016.

As stated earlier, the Company had taken appropriate steps to address the observations it had received from these audits. Having received the EIRs from the US FDA about the closure of these inspections, all observations stand addressed, and both these facilities are cGMP compliant.

 

About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing 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 largest and fastest growing top 10 generics player in the US (5.6% market share by prescriptions, IMS Health, September 2015) and the 2rd largest Indian pharmaceutical company by market capitalization. The Company is also the 9th 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 turnover and Profit after Tax stood at Rs. 137,016 million (USD 2.09 billion) and Rs. 22,707 million (USD 347 million) respectively.

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CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai - 400 098

 

For more information, please contact –

 

Shamsher Gorawara
Head - Corporate Communications
Ph: +91-22- 98 20 338 555
Email: shamshergorawara@lupin.com

or

Alpesh Dalal
Head - M & A and Investor Relations
Lupin Limited
Ph: +91 98 20 023 511
Email: alpeshdalal@lupin.com

 

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