Lupin receives establishment inspection report from USFDA, inspection conducted from March 6 to March 15
Upstox
2 min read • Updated: April 24, 2024, 1:11 PM
Summary
Lupin stated that the USFDA has determined that the inspection classification of the facility is voluntary action indicated (VAI). Recently, the company had announced the launch of Mirabegron extended-release tablets, 25 mg, in the United States, after having received the USFDA approval.
Pharma major Lupin announced on Tuesday that it has received the establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for its Aurangabad manufacturing facility.
The inspection was conducted from March 6 to March 15, 2024, the company said in an exchange filing. The USFDA has determined that the inspection classification of the facility is voluntary action indicated (VAI), it said. According to USFDA, VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Recently, the company had announced the launch of Mirabegron extended-release tablets, 25 mg, in the United States, after having received the USFDA approval. Mirabegron extended-release tablets, 25 mg is a generic equivalent of Myrbetriq extended-release tablets, 25 mg of Astellas Pharma Global Development, Inc. It had an estimated annual sales of $1,019 million in the US, the company stated.
The company also announced the launch of its first generic version of Oracea (Doxycycline Capsules, 40 mg) in the United States, after having received an approval from the USFDA.
Lupin recently said that it is proposing to transfer its trade generics business in India along with all related assets and liabilities to Lupin Life Sciences, a wholly-owned subsidiary of the company. The completion of sale is expected to be done by June 30, 2024, it said in an exchange filing. The consideration expected to be received stands at ₹100-120 crore, Lupin had said. It indicated that the slump sale will lead to agility, better focus and growth of trade generics business.
For the third quarter of fiscal year 2024, Lupin had reported a 19.7% year-over-year (y-o-y) rise in its sales at ₹5,079.90 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) increased 93.8% to ₹1,067.30 crore. EBITDA margin improved by 800 basis points to 21%. Net profit jumped 292.6% to ₹618.70 crore during the quarter.
Shares of Lupin have gained over 20% since the beginning of the year. The stock has risen over 125% in the last one year.