Drug firm Lupin Monday said it has received an establishment inspection report (EIR) from the US health regulator post the inspection of its Nagpur facility.
Drug firm Lupin Monday said it has received an establishment inspection report (EIR) from the US health regulator post the inspection of its Nagpur facility.
"The United States Food and Drug Administration (USFDA) conducted a pre approval inspection for its Phenytoin Sodium Extended Release 100 mg capsules," Lupin said in a filing to BSE.
The plant was inspected by USFDA in September 2018, the company added.
USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.
Commenting on the development, Lupin MD Nilesh Gupta said: "The successful completion of the Nagpur facility inspection is a positive development as we continue our journey to meet and exceed international regulatory standards." Shares of Lupin were today trading 1.64 per cent higher at Rs 868.20 apiece on BSE.
Meanwhile, Drug major Lupin is looking to establish presence in China as part of its strategy to strengthen its markets in the Asia Pacific region, a senior company official said.
The Mumbai-based firm expects to generate revenues of over USD 100 million from the region, excluding the Japanese market, over the next few years.Lupin recognises the importance of emerging markets in APAC to drive its future growth, particularly in Southeast Asia where the pharmaceutical market and demand are growing significantly, Lupin President - APAC and Japan Fabrice Egros told PTI.
With that in mind, the company plans to further strengthen its presence in the Philippines, Vietnam and Myanmar where it has already started some sales via distributors and continue to register new products.
In Malaysia and Thailand, Lupin products have been submitted for approval to regulatory agencies. We are also exploring ways in which we might establish a presence in China, Egros said.
When asked if the company has set any target in terms of revenues from this region, Egros said: We aim to generate USD 100 million sales from non-Japanese APAC markets in the coming years. In 2017-18, Lupin's APAC business sales stood at Rs 2,572.5 crore, accounting for 17 per cent of Lupin's global sales.
Lupin's Japan FY2018 sales increased 23.4 per cent to JPY 35.478 billion compared to FY2017.
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 "Lupin gets EIR from USFDA for its Nagpur facility")
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