Zydus Pharmaceuticals

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 .

Cadila Healthcare at the forefront, looks at biologic drug to treat Covid

Company is already working on developing 2 vaccine candidates, diagnostic kits and also making HCQ

Zydus Pharma gets USFDA nod to market attention-deficit hyperactivity drug

The final approval from the United States food and drug administration (USFDA) is to market Dextroamphetamine Saccharate

Zydus arm receives USFDA nod to market Omega-3-Acid Ethyl Esters capsules

Omega-3-acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat

Zydus gets final USFDA nod for anti-bacterial drug to treat acne, malaria

Zydus Cadila is a global pharmaceutical company that develops, manufactures and markets a broad range of healthcare therapies

Zydus Pharmaceuticals receives USFDA nod to market OCD treatment drug

Zydus Pharmaceuticals Inc is a wholly-owned subsidiary of Cadila Healthcare Ltd

Zydus gets US health regulator nod for hypertension drug Nifedipine

The company will produce the drug at the group's formulations manufacturing facility at SEZ, Ahmedabad.