 "Zydus Life stock sheds 5% as USFDA issues 10 observations for Vadodara unit")
Shares of Zydus Lifesciences shed 4.7 per cent to hit an intraday low of Rs 916.4 per share after the US Food and Drug Administration (USFDA) issued 10 observations against the company's Injectable Manufacturing site in Vadodara.
At 10:15 AM, Zydus Life stock price was down 3.7 per cent at Rs 923.5 per share as against 0.4 per cent rise in the benchmark S&P BSE Sensex.
"The USFDA conducted an inspection at the Injectable Manufacturing site situated at Jarod, near Vadodara, between April 15 and April 23, 2024. The inspection was closed with 10 observations," the company said in an exchange filing.
Going ahead, the company will closely work with the USFDA to address and respond to the observations in an expeditious manner, it added.
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), is one of India's leading pharmaceutical companies. From formulations to active pharmaceutical ingredients and animal healthcare products to wellness products, Zydus provides comprehensive and complete healthcare solutions.
According to analysts at Equirus, Zydus Life may report a solid 17 per cent quarter-on-quarter (Q-o-Q) growth in net sales in the March quarter of FY24 (Q4FY24). It has pegged the same at Rs 52,661 crore vs Rs 45,052 crore in Q3FY24 and Rs 50,106 crore in Q4FY23.
Ebitda, too, it said, may see a string surge of 42 per cent Q-o-Q and 17 per cent Y-o-Y at Rs 15,324 crore. Net profit, meanwhile, may rise 7 per cent Q-o-Q but 266 per cent Y-o-Y to Rs 10,869 crore.
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"Strong sequential increase is on the back of resumption of new supplies for gRevlimid, residual US business will remain flattish owing to derth of new launches," it said in its result preview report.
Those at Motilal Oswal Financial Services, on the other hand, observed that the US sales could grow 10 per cent Y-o-Y due to gradual ramp-up of niche launches supported by Revlimid. It expects DF sales to grow by 6 per cent Y-o-Y for the quarter due to moderate growth in key therapies.
"Investors should watch out for the progress on launching limited competition products in the US market, and scaling up the Liqmeds business. That apart, spdate on the progress of development of NCE pipeline is a key monitorable," the brokerage said.
Meanwhile, recently, Zydus Lifesciences' New Drug Application（NDA) of Desidustat Tablets was accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management Limited, a wholly-owned subsidiary of China Medical System Holdings Limited, obtained an exclusive license for the Product from Zydus in 2020.
That apart, Zydus launched Mirabegron Extended-Release Tablets, 25 mg in the US market on April 22, 2024.
"Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently. These tablets had annual sales of $2.42 billion in the US," it said in an exchange filing.
Zydus Group now has 393 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.