Pharma major Lupin Ltd said on Friday it has got an establishment inspection report (EIR) from the US Food and Drug Administration for its Aurangabad facility.
"This takes us a step forward in our efforts of enhancing our compliance and quality standards across all our manufacturing sites," said Managing Director Nilesh Gupta.
"We continue to work with the US FDA to continuously improve our quality and compliance while providing important medicines to the US market," he said in a statement.
The inspection for Aurangabad facility was carried out between February 10 and 14, and concluded with no observations.
"We are delighted with the receipt of EIR for Aurangabad classifying the inspection as 'no action indicated.'
At 11:20 am, the company's stock was trading 10 per cent higher at Rs 637.10 per unit on BSE Ltd.
Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products and active pharma ingredients in over 100 markets in India, the United States, South Africa, across Asia Pacific, Latin America, Europe and Middle East regions.
It is the third largest pharmaceutical company in the United States by prescriptions and in India by global revenues. The company invests 9.6 per cent of its revenues on research and development.
Lupin has 15 manufacturing sites, seven research centres and more than 20,000 professionals working globally.
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