Lupin - U.S. FDA Regulatory Hurdle Crossed At Goa: Motilal Oswal

Lupin - U.S. FDA Regulatory Hurdle Crossed At Goa: Motilal Oswal

Duloxetine delayed-release capsules sit inside a bottle beside other empty bottles inside the packaging unit at the Lupin Ltd. (Photographer: Dhiraj Singh/Bloomberg)  

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Motilal Oswal Report

After almost 4.5 years of regulatory hurdles, Lupin Ltd. received a favorable classification (Voluntary Action Indicated) for its Goa facility from the U.S. Food and Drug Administration.

This is a big relief from a compliance standpoint, given the reasonable contribution in the base business as well as double digit abbreviated new drug applications pending approval from the Goa site.

We expect 21% earnings compound annual growth rate over FY21-23E and raise our 12-month forward price/earning to 25 times (to factor Goa compliance) from 24 times earlier.

While the regulatory clearance removes a key overhang on Goa facility, we maintain our stance on Lupin as valuation leaves limited upside from current levels.

Click on the attachment to read the full report:

Motilal Oswal Lupin Company Update.pdf
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