Page 7 - Zydus Lifesciences

Zydus Lifesciences gets US health regulator nod for generic products

Zydus Lifesciences on Monday said it has received approval from the US health regulator to market generic medicines in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market Gabapentin tablets which are indicated for the management of postherpetic neuralgia (PHN). As per IQVIA MAT data, the medication had annual sales of USD 90 million in the US. The company said it also has received approval from the US health regulator for diabetes drug Canagliflozin and Metformin Hydrochloride tablets. As per IQVIA MAT data, Canagliflozin and Metformin Hydrochloride tablets had annual sales of USD 49.4 million in the US. Shares of the company on Monday ended 1.36 per cent down at Rs 464.15 apiece on the BSE.

Zydus Lifesciences net profit rises 24.48% to Rs 622.9 cr in Dec quarter

Zydus Lifesciences Ltd on Friday reported a 24.48 per cent rise in consolidated net profit at Rs 622.9 crore for the third quarter ended December 31, 2022. The company had posted a consolidated net profit of Rs 500.4 crore in the same period last fiscal, Zydus Lifesciences Ltd said in a regulatory filing. Consolidated total revenue from operations during the quarter under review stood at Rs 4,362.3 crore, as against Rs 3,639.8 crore in the year-ago period, it added. Total expenses in the third quarter were higher at Rs 3,620.7 crore, as compared to Rs 3,096.3 crore in the corresponding period last fiscal. In the third quarter, its business in India comprising formulations as well as consumer wellness registered revenues of Rs 1,643.6 crore, up 13 per cent, while the US formulations business registered revenues of Rs 1,925 crore, up 29 per cent from the year-ago period, the company said. Emerging markets formulations business registered revenues of Rs 307.8 crore, up 15 per cent an

Strong US sales momentum may drive further gains for Zydus Lifesciences

Market share gains in the Indian market and margin expansion are other positives

Zydus gets USFDA nod to market generic medicine for treating depression

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults

Zydus Lifesciences launches generic anti-epilepsy drug in US market

Zydus Lifesciences on Friday said it has launched generic epilepsy treatment medication in the US market. Zydus Pharmaceuticals (USA) Inc, a unit of the company, has launched Topiramate extended-release capsules in the American market. The company had earlier received final approval from the US Food and Drug Administration (USFDA) to market the product in strengths of USP 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a statement. Zydus is the first company to receive final approval and launch the medication in the above mentioned strengths, it added. Topiramate extended-release capsules are indicated for epilepsy: initial monotherapy in patients who are six years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated for prophylaxis of migraine in patients 12 years of age and older. As per IQVIA data, Topiramate extended-release capsule had annual sales of USD 488 million in the US.

Zydus Life gets final nod from USFDA for generic version of insomnia drug

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to market its generic version of Triazolam tablets used on a short-term basis to treat insomnia. The approval granted by the US Food and Drug Administration (USFDA) is to market Triazolam tablets of strengths 0.125 mg and 0.25 mg, the company said in a regulatory filing. The medicine is used on a short-term basis to treat insomnia -- difficulty falling asleep or staying asleep. It works by slowing activity in the brain to allow sleep. It will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, the company said. Triazolam tablets had annual sales of USD 11.7 million in the US, the company said, citing IQVIA MAT September 2022 data.

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Zydus Lifesciences Q2 net profit down 82.6% to Rs 523 cr on rising costs

Shares of the company were trading at Rs 427.70, down 1.4% at 0847 GMT

Zydus Lifesciences gets USFDA's nod for generic hypertension drug

Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to market blood pressure lowering drug Bisoprolol Fumarate and Hydrochlorothiazide tablets in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market the generic medication in multiple strengths, the Ahmedabad-based drug maker said in a statement. Bisoprolol Fumarate and hydrochlorothiazide combination is indicated to treat high blood pressure (hypertension). The drug will be manufactured at the company's formulation manufacturing facility at Ahmedabad SEZ, the company said. As per IQVIA MAT September 2022 data, Bisoprolol Fumarate and Hydrochlorothiazide tablets had annual sales of USD 27.1 million in the United States.

Zydus gets establishment inspection report from USFDA for Moraiya plant

Zydus Lifesciences on Monday said it has received an establishment inspection report from the US health regulator for its formulations manufacturing facility in Moraiya near Ahmedabad. The US Food and Drug Administration (USFDA) inspected the facility from July 26 to August 5, 2022, which concluded with four observations. "The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)," it added. The USFDA issues an establishment inspection report (EIR) to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection. Shares of Zydus Lifesciences were trading 2.51 per cent up at Rs 450.85 apiece on the BSE.

Zydus Lifesciences gets USFDA nod for generic Valbenazine, Roflumilast

Zydus Lifesciences on Monday said it has got tentative approval from the US health regulator to market its generic versions of Valbenazine capsules and Roflumilast tablets. Valbenazine capsules are indicated for the treatment of tardive dyskinesia (uncontrolled movement of body parts such as face and tongue) while Roflumilast tablets are used for reducing risk of chronic obstructive pulmonary disease in severely affected patients associated with chronic bronchitis and a history of exacerbations. The tentative approval granted by the US Food and Drug Administration (USFDA) to the company's arm Zydus Worldwide DMCC to market Valbenazine capsules is for strengths 40 mg, 60 mg, and 80 mg, Zydus Lifesciences said in a regulatory filing. As per IQVIA MAT August 2022 data, Valbenazine capsules had annual sales of USD 781 million in the US. Zydus further said its US subsidiary Zydus Pharmaceuticals (USA) Inc has also received tentative approval from the USFDA to market Roflumilast tablets

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Zydus Lifesciences' generic drug for overactive bladder gets USFDA nod

Zydus Lifesciences on Monday said it has received the USFDA's final nod to market its generic version of Mirabegron extended-release tablets used to treat overactive bladder, with 180 days of shared generic drug exclusivity. The final approval granted by the US Food and Drug Administration (USFDA) to the company's US arm Zydus Pharmaceuticals Inc is for the tablets of strengths 25 mg and 50 mg, it said in a regulatory filing. Zydus was one of the first applicants to submit a substantially complete ANDA (abbreviated new drugs application) with a paragraph IV certification for Mirabegron extended-release tablets, 25 mg and 50 mg and is therefore eligible for 180 days of shared generic drug exclusivity for the drug, it added. Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the filing added. As per

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Zydus Lifesciences US arm gets tentative USFDA nod for Sugammadex injection

Zydus Lifesciences Ltd on Friday said its US-arm has received tentative approval from the country's health regulator to market its generic version of Sugammadex injection. The injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The tentative approval granted by the US Food and Drug Administration (USFDA) to Zydus Pharmaceuticals (USA) Inc is for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), single-dose vial, the company said in a regulatory filing. The drug will be manufactured at the group's injectables manufacturing facility at Jarod (Gujarat), India, it added. Sugammadex Injection had annual sales of USD 772 million in the US, the company said citing IQVIA MAT July 2022.

Zydus gets USFDA nod to sell its cancer medicine in American market

Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to sell Lenalidomide capsules, used in the treatment of various types of cancers, in the American market. The company has received approval from the US Food and Drug Administration (USFDA) to market the product in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders. The drug maker said the drug will be manufactured at the group's formulation facility at Ahmedabad SEZ. "We remain focused on providing patients access to affordable medication and USFDA approval of Lenalidomide Capsules, an important oncology therapy product, is yet another step in this endeavour," Zydus Lifesciences Managing Director Sharvil Patel stated. According to IQVIA MAT July data, Lenalidomide had annual sales of USD

Zydus acquires rights to market MonoFerric injection in India, Nepal

Zydus Lifesciences Ltd on Friday said it has acquired rights to market MonoFerric (iron isomaltoside) injection, used to treat iron deficiency in adult patients, in India and Nepal from Denmark-based Pharmacosmos A/S. MonoFerric is indicated for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly, the company said in a regulatory filing. Zydus Lifesciences did not disclose the financial details of the transaction. Iron Deficiency is a severe healthcare challenge and also impacts the quality of life more so in CKD (chronic kidney disease) patients, Zydus Lifesciences Managing Director Dr Sharvil Patel said. With this introduction, he said these patients will get access to this critical therapy which will be enhanced by the company's "strong last-mile delivery". The MonoFerric iron isomaltoside 1,000 solution for injection/infusion, is a rapid, single dose IV iron (

Zydus gets USFDA nod for generic version of Venlafaxine, Pregabalin

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic version of venlafaxine extended-release tablets used to treat depression. The company also said the US Food and Drug Administration (USFDA) has granted final approval for pregabalin extended-release tablets used to treat pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection. The approval granted by the USFDA for venlafaxine extended-release tablets is for strengths of 37.5 mg, 75 mg, 150 mg and 225 mg, Zydus Lifesciences said in a regulatory filing. Venlafaxine is used to treat depression, anxiety, panic attacks and social anxiety disorder. It had annual sales of USD 46 million in the US, the company said citing IQVIA MAT July 2022. Further, Zydus Lifesciences said the final approval granted by the USFDA to market pregabalin extended-release tablets is for strengths of 82.5 mg, 165 mg and 330 mg. The drug had annual sales of USD 3 ..

Zydus gets USFDA approval to market generic antifungal medication

Zydus Lifesciences on Monday said its subsidiary has received approval from the US health regulator to market antifungal Efinaconazole Topical solution