Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1,313.05 per share on the BSE in Friday's intraday deals
The uptick in the stock price came after the pharmaceutical company announced that it has secured an approval from COFEPRIS of Mexico to market Mamitra to treat various cancers.
The shares surged after the pharmaceutical major announced that it has secured final nod from United States Food and Drug Administration (USFDA) for Valsartan tablets.
Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent
The fall in the stock came after the company announced that it has secured an Official Action Indicated (OAI) report from the United States Food and Drug Administration (USFDA).
At 6:36 AM, GIFT Nifty futures were up 19 points, trading at 24,828.50 levels, indicating a higher start for the day.
Zydus Lifesciences on Thursday said the US health regulator has cautioned that its Gujarat-based injectables plant may be subject to regulatory actions. The company said it has received a report from the US Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat between April 15-23, 2024. The USFDA has determined that the inspection classification of this facility is Official Action Indicated (OAI), it added. According to FDA, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during the inspection. "The company will work closely with the agency to resolve the regulatory status of this facility expeditiously," the drug maker said. Shares of Zydus Lifesciences settled marginally up at Rs 1,185.30 apiece on the BSE.
Vault works by inhibiting the production of stomach acid and is approved by the Drugs Controller General of India (DCGI) for the treatment of reflux esophagitis and other acid peptic disorders (APDs)
Shares of Zydus Lifesciences zoomed up to 1.93 per cent, hitting its all time high at Rs 1203.20 per share on the BSE in Thursday's intraday trade
Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Sacubitril and Valsartan tablets combination used to treat chronic heart failure in adults. The approval by the US Food and Drug Administration (USFDA) is to market Sacubitril and Valsartan tablets of strengths 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing. Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company added.
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Zydus Lifesciences Ltd on Friday said it has received tentative approval from the US health regulator to market Azilsartan Medoxomil and Chlorthalidone tablets, which are indicated for the treatment of high blood pressure. The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing. Azilsartan and Chlorthalidone are diuretic combination products indicated for the treatment of high blood pressure to lower blood pressure, it added. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ- II, India, the company said. Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of USD 77.9 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.
Among individual players, Aurobindo Pharma, Dr Reddys Labs, and Zydus Lifesciences sourced 48 per cent, 47 per cent, and 46 per cent of their total revenues from the US generics segment, respectively
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EBITDA margin for the quarter stood at 29.5 per cent, an improvement of 440 bps on a YoY basis.
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On a sequential basis, the company exhibited a 22.83 per cent increase in revenue, the PAT also rose by 53.57 per cent
Indian generic drugmakers, which draw a significant share of revenue from the crucial U.S. market, are recovering from the effects of eroding prices in the largest drug market in the world
MSN Lab will manufacture and supply Cabozantinib; Zydus will handle marketing, distribution and sales