Page 2 - Zydus Pharmaceuticals

Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition. The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing. Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition, coronary artery disease, it added. The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the company said. Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual sales of USD 47 million in the US, Zydus said citing IQVIA December 2023 data. PTI RKL.

Zydus Group to invest Rs 5,000 cr across various sectors in Gujarat: Patel

Zydus Group on Friday announced plans to invest Rs 5,000 crore in Gujarat in various sectors, including new generation biotechnology products and hospitals, its Chairman Pankaj Patel said. Speaking at the 10th Vibrant Gujarat Global Summit here, Patel said his group has signed Memoranda of Understanding (MoUs) with the state for the investments. "We have signed MoUs of over Rs 5,000 crore. We'll be investing into next generation biotechnology products, new medical device initiatives and hospitals for the healthcare sector," he said. Patel said he has been attending the biennial summit since its inception and thanked Prime Minister Narendra Modi and Union Home Minister Amit Shah for helping businesses when it needs it the most. He said business needs leadership with a vision and the one that pushes it to think bigger, which is offered in Gujarat. Earlier, Nayara Energy's head of refinery Prasad Panicker said the company will be expanding its refinery at Vadinar and also upping its

Zydus Lifesciences gets USFDA nod to sell generic anti-epileptic medication

Zydus Lifesciences on Saturday said it has received approval from the US health regulator to market a generic anti-epileptic medication. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets in multiple strengths, the drug firm said in a statement. Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. The company said it will manufacture the product at the group's formulation manufacturing facility in Moraiya, Ahmedabad. As per IQVIA data, Lacosamide Tablets had annual sales of USD 249 million in the US.

Zydus, Daewoong collaborate to co-develop, market Leuprolide Acetate

Daewoong will leverage its proprietary technology to produce Leuprolide Acetate for Depot Suspension in its manufacturing facilities located in Osong, South Korea

Zydus gets USFDA nod for Zituvimet for type-2 diabetes mellitus treatment

The company said that Zituvimet has undergone quality testing for Nitrosamines and potential genotoxic impurities according to current FDA standards

Lupin's subsidiary, Generic Health gets Tiotropium 18 micrograms approval

The company has received the approval from Therapeutic Goods Administration (TGA)

Pharma companies seek price ceiling exemption for low-cost medicines

The industry and the government are on the same page on trade margin rationalisation, however, the industry wants it to be implemented in a phased manner

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 gets DCGI nod for drug to treat anaemia linked with kidney disease

Zydus Lifesciences on Monday said it has received an approval from the DCGI for Oxemia (Desidustat), a first-of-its-kind oral treatment for anaemia associated with chronic kidney disease

Zydus gets regulator nod to market generic diabetes drug in American

Zydus Group on Wednesday said it has received final approval from the US health regulator to market diabetes medication Dapagliflozin tablets in the American market. The drug maker has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 5 mg and 10 mg. Dapagliflozin is used with a proper diet and exercise programme to control high blood sugar in people with type 2 diabetes. The drug also lowers the risk of heart failure in adults with type 2 diabetes with heart disease. It is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalisation for heart failure in adults with chronic kidney disease. Dapagliflozin works by increasing the removal of sugar by kidneys. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Group stated. The group now has 328 approvals and has so far fi

Zydus Pharma gets final USFDA approval to market Roflumilast tablets

Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug exclusivity

Zydus gets nod for phase 2 clinical study in Australian CAPS patients

Zydus Cadila on Monday said it has received approval to commence Phase II clinical study of its upcoming product with patients suffering with Cryopyrin-Associated Periodic Syndromein Australia.

Dr Reddy's Laboratories, Zydus Pharma recall products in US market

Dr Reddy's Laboratories, Inc, the US arm of Dr Reddy's Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg

Zydus Cadila gets USFDA nod for cancer, high blood pressure treatment drug

Drug firm Zydus Cadila on Thursday said it has received final approval from the US health regulator to market Ibrutinib Capsules, used to treat certain cancers

Zydus seeks DCGI nod for add'l indication of Hep C drug in Covid-19 therapy

In a likely breakthrough, interim results indicate that PegIFN when administered early on, could help patients recover faster and avoid complications seen in advanced Covid stages

November domestic pharma sales grow just 1% after strong show last month

Oct growth rate was 9.6%; Most big corporates saw volumes drop in November

Will focus on three-pronged strategy to drive growth: Zydus Wellness

The company is also planning to enter new markets with relevant offering as part of expanding its geographical footprint, Zydus Wellness said

Zydus Wellness board approves fund-raising of up to Rs 1,100 crore

As of quarter ended June 30, 2020, Zydus Family Trust held 4.29 per cent stake in Zydus Wellness

Zydus Cadila launches India's 'cheapest' remdesivir at Rs 2,800 per vial

Zydus is the fifth company to launch a copy of the antiviral in India after privately held Hetero Labs Ltd, Cipla, Mylan NV and Jubilant Life Sciences Ltd

Zydus Wellness June quarter net profit increases 11% at Rs 89 crore

Zydus group firm Zydus Wellness on Friday reported a 10.94 per cent rise in consolidated net profit at Rs 89.20 crore for the quarter ended June 30, 2020. The company had posted a net profit of Rs 80.40 crore for the corresponding period of the previous year,Zydus Wellness said in a filing to BSE. Consolidated revenue from operations of the company stood at Rs 537.37 crore for the quarter under consideration, as against Rs 620.25 crore in the year-ago period, it added. The past quarter was an "unprecedented one" due to the COVID-19 pandemic impacting the company's operations in the early part of the quarter, Zydus Wellness said. "However, with the logistical challenges being resolved and approvals for re-starting manufacturing plants and operating C&FA warehouses coming in, the company was able to recover from the early setbacks,"it added. Coping with the pandemic, the company continues to be agile in its responses and execution of its plans,Zydus Wellness said. Shares of Zydus .