Page 4 - Zydus Lifesciences

Zydus Lifesciences arm gets Rs 284.58 cr income tax demand notice

Zydus Lifesciences on Tuesday said its arm Zydus Healthcare Ltd has been served an income tax notice demand of Rs 284.58 crore for for the assessment year 2023-2024. Zydus Healthcare Ltd (ZHL), a wholly-owned subsidiary, has received an intimation under section 143(1) of the Income Tax Act, 1961 (IT Act), determining demand of Rs 284.58 crore, Zydus Lifesciences said in a regulatory filing. The intimation is for the assessment year 2023-2024 from the CPC, Income Tax Department, it added. The demand is determined due to "apparent mistakes while processing its return of income", it said. "The company strongly believes that once the rectification will be made, the entire demand will be deleted," Zydus Lifesciences said. ZHL has already disagreed with demand on the e-filing portal of the Income Tax Department. It is also going to file Rectification Application under section 154 of the IT Act, before the CPC as well as before the Jurisdictional Assessing Officer against the said ...

Zydus Lifesciences gets six observations from USFDA for API plant

Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing. There were no data integrity related observations, it added. Besides, there are no repeat observations from the previous inspection, it noted. There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said. The company will closely work with the USFDA to address the observations, it added.

Zydus Noveltech dissolved for not generating 'meaningful revenue'

It had nil operating revenue and a net worth of Rs 10 crore as of March 31, 2023

Zydus Noveltech Inc dissolved after 'not generating meaningful revenue'

Dissolution of Zydus Noveltech Inc will not affect the business operations of the company, said Zydus Lifesciences

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 gets USFDA's approval for antiviral drug used in HIV treatment

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic antiviral medication used in the treatment of HIV-1 infection. The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement. Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body. It is indicated for the treatment of HIV-1 infection in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients three years of age and older. It must be co-administered with Ritonavir and with other antiretroviral agents. Zydus said the product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad, Gujarat. As per IQVIA MAT data, Darunavir tablets (75 mg, 150 mg, 600 mg, and 800 mg) had annual sales of USD 275 million in the US. Shares of the company were trading

Zydus Lifesciences gets final FDA nod for Darunavir for HIV-1 treatment

According to market research firm IQVIA, Darunavir Tablets, 75 mg, 150 mg, 600 mg, and 800 mg had annual sales of $275 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 Lifesciences receives USFDA approval for Ivabradine tablets

On Friday, shares of Zydus Lifesciences were up/down by 0.34 per cent, ending the day's trade at Rs 640 apiece on the BSE

Torrent Pharma inks licensing pact with Zydus for liver disease drug

Torrent Pharmaceuticals on Friday said it has inked a licensing agreement with Zydus Lifesciences to co-market a product for the treatment of non-alcoholic steato hepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD). As per the agreement, the companies will co-market Saroglitazar Mg in the country. Under the terms of this agreement, Torrent will have semi-exclusive rights to co-market the product in India under the brand name Vorxar, Torrent said in a statement. Zydus launched the drug under the brand names Lipaglyn and Bilypsa and will continue to market them. Torrent will pay Zydus upfront licensing fees and milestone payments based on the achievement of pre-defined milestones, it noted. As the only approved drug for NASH and NAFLD in the country, Saroglitazar Magnesium is likely to play a key role in managing and mitigating these progressive and prevalent liver disorders. Currently, there is no approved drug for the treatment of NASH and NAFLD anywhere else in the ..

Torrent, Zydus collaborate to bring liver disease treatment to India

Saroglitazar Mg received approval in March 2020 for NASH treatment and later expanded its indications to include NAFLD

Zydus Lifesciences Q2 profit jumps 53% on strong domestic, US demand

Total revenue from operations rose 9.1 to Rs 4,369 crore, boosted by the strength in US formulation segment, which constitutes 44 of the business

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

Zydus ties up with Guardant to promote cancer tests across India, Nepal

Zydus Lifesciences on Thursday said it has joined hands with oncology firm Guardant Health to jointly promote a portfolio of liquid and tissue biopsy tests across India and Nepal. The companies have inked a co-marketing agreement to jointly promote the Guardant360 portfolio in India and Nepal. The tests to be promoted include the Guardant360 and Guardant360 TissueNext tests for comprehensive genomic profiling and the Guardant360 Response test for monitoring response to treatment, the drug maker said in a statement. The agreement demonstrates a shared commitment to advance precision medicine and improve patient outcomes in the region, it added. By combining resources and expertise, both organisations aim to empower oncologists with the necessary tools to help inform treatment decisions for patients with advanced cancer, Zydus noted. "This collaboration with Zydus to co-promote the Guardant360 portfolio across their extensive network signifies our mutual commitment to address unmet

Zydus Lifesciences acquires UK-based LiqMeds Group for 68 million pounds

Zydus Lifesciences on Tuesday said it has acquired UK-based LiqMeds Group for GBP 68 million (around Rs 689 crore). The Ahmedabad-based group, through its wholly-owned subsidiary Zydus Pharmaceuticals UK Ltd, will also pay yearly earn-outs until 2026 depending on the achievement of certain agreed milestones towards the acquisition. LiqMeds Group of companies specialises in the development, manufacturing and supply of oral liquid products for global markets. The group's subsidiary LM Manufacturing Ltd has an oral liquids manufacturing site at Weedon, Northampton, UK, which supplies products to the US and UK markets. "Zydus will pay an upfront consideration of GBP 68 million and yearly earn-outs until 2026 depending on the achievement of certain agreed milestones towards the acquisition of the LiqMeds Group of companies," the company said in a regulatory filing. The transaction will be EPS accretive for Zydus from the first year of acquisition, it added. "We believe that liquid ora

Sun Pharma and Zydus Lifesciences partner to market kidney drug Desidustat

Under this licensing agreement, Zydus has granted Sun Pharma semi-exclusive rights to co-market Desidustat in India

Zydus, Sun Pharma ink licensing pact to co-market CKD treatment drug

Zydus Lifesciences on Monday said it has inked a pact with Sun Pharma to sell in the country an oral treatment medication for anemia associated with chronic kidney disease (CKD). The companies have entered into a licensing agreement to co-market the innovative drug, Desidustat, in India, Zydus said in a regulatory filing. Under the terms of the agreement, Zydus has granted Sun Pharma semi-exclusive rights to co-market the product in India, it stated. Sun Pharma will market the drug under the brand name Rytstat, it added. Zydus has launched the drug under the brand name Oxemia in 2022 and will continue to market it in the domestic market. As part of the deal, Zydus will receive upfront licensing income and is eligible to receive milestone income based on achievement of pre-defined milestones, the drug firm noted. "Desidustat which is one of the critical treatment options for CKD patients has substantially improved the patients' quality of life since it is more convenient to take a

Zydus appoints Punit Patel as President & CEO for North American Operations

Punit Patel brings over 20 years of experience in both generic and branded pharmaceutical sectors

Zydus Lifesciences appoints Punit Patel as president & CEO of Americas

Punit Patel will oversee the business operations of all Zydus entities in North America, including generics, injectables, specialty business, rare and orphan disease portfolio

Zydus unit recalls 7,248 bottles of Oxybutynin Chloride tablets in US

A unit of Zydus Lifesciences is recalling over 7,000 bottles of Oxybutynin Chloride tablets in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator said the drugmaker is recalling 7,248 bottles of Oxybutynin Chloride extended-release tablets, used to treat overactive bladder and urinary conditions, in the US. New Jersey-based Zydus Pharmaceuticals (USA) Inc. is recalling the affected lot due to "Failed Dissolution Specifications", the USFDA stated. The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated. The drug firm initiated the Class II recall on September 21 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse hea