Lupin Ltd — Regulatory Filings 2018

Nov 12, 2018

Press Release

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BSE: 500257 NSE: LUPIN REUTERS: LUPIN.BO BLOOMBERG: LPC IN

Lupin’s Nagpur facility receives EIR from US FDA

Mumbai, November 09, 2018: Pharma major Lupin today announced the receipt of the Establishment Inspection report (EIR) post the completion of a Pre-Approval Inspection (PAI) for its Phenytoin Sodium Extended Release 100 mg capsules, carried out by the US FDA at its Nagpur facility in Maharashtra. The inspection conducted in September 2018 concluded without any observations.

Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage products. The site also houses Lupin’s state of the art injectable manufacturing facility.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “The receipt of the EIR for our Nagpur facility is a positive development as we continue our journey on meeting and exceeding global quality standards at all of our facilities.”

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 13[th] largest generics pharmaceutical company in terms of market capitalization (30[th] September 2018, Bloomberg) and the 8[th] largest generics pharmaceutical company in terms of revenues (30[th] June 2018, Bloomberg LTM) globally. The Company is the 3[rd] largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT September 2018); 3[rd] largest Indian pharmaceutical company by global revenues (30[th] June 2018, Bloomberg LTM); 6[th] largest generic pharmaceutical player in Japan (IQVIA MAT September 2018) and 5[th] largest company in the Indian Pharmaceutical Market (IQVIA MAT September 2018).

For the financial year ended 31[st] March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal

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 –

Pooja Thakran VP – Corporate Communications Email: poojathakran@lupin.com Ph: +91-22-66402531 / 8291013225

Arvind Bothra Head – Investor Relations Email: arvindbothra@lupin.com Ph: +91-22-66402137

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