Page 12 - Zydus Lifesciences

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

Stocks to watch: TCS, Tata Motors, Mahindra Holidays, D-Mart, Adani Group

Stocks to watch today: IT behemoth TCS net profit grew 5.2 per cent year-on-year (YoY) to Rs 9,478 crore in Q1FY23; Tata Motors hiked prices across passenger vehicle range by 0.55 per cent.

Zydus Life launches generic version of Sitagliptin for type 2 diabetes

Zydus Lifesciences Ltd on Friday said it has launched the generic version of sitagliptin in India under the brand names Sitaglyn and Siglyn to address type 2 diabetes.

Zydus Lifesciences' chairman appointed as director in RBI's board

Zydus Lifesciences on Tuesday said its chairman Pankaj R Patel has been appointed as a part time non-official director in the central board of the Reserve Bank of India (RBl). The Appointments Committee of the Cabinet (ACC) has approved the proposal of appointment of Patel for a period of four years from the date of notification of his appointment, or until further orders, whichever is earlier, the drug maker said in a statement. Patel is already on the board of various institutions, including Invest India, Member of the Mission Steering Group (MSG) -- the highest policy making and steering body constituted under National Health Mission (NHM), and of the Drug Technical Advisory Board by the ministry of health & family welfare, it added. He is also the chairman of the Board of Governors and Society, IIM, Udaipur and a member of the Board of Governors of the Indian Institute of Management (IIM), Ahmedabad. Patel was also the president of the Federation of Indian Chamber of Commerce

Sensex falls 153pts; Nifty below 15750; Bajaj Auto dips 5%, Adani Ent up 6%

CLOSING BELL: Select IT, metals, and pharma stocks helped the headline indices recover from the day's low

Stocks to watch: Bajaj Finance, Zydus Lifesciences, Tata Steel, Amara Raja

Stocks to watch today: Bajaj Finance has raised fixed deposit rates by up to 20 basis points; Zydus Lifesciences will open its share buyback offer on June 23 and close on July 6.

Zydus Lifesciences' Rs 750 cr-share buyback open between June 23-July 6

The drug firm, earlier known as Cadila Healthcare, has fixed July 15, 2022 as the last date for the settlement of bids on stock exchanges which may even happen early, as per a regulatory filing.

Ahmedabad-based Zydus gets USFDA approval to market generic acne drug

A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease the number and severity of acne pimples

Launches, base biz expansion tonic for Dr Reddy's double-digit growth

While the company's bottom line grew 10.5% annually over the 2016-17 through 2021-22 (FY22) period, it is expected to register thrice that growth rate over next two years, observes ICICI Securities

Zydus Lifesciences Q4 net dips to 24% Rs 397 cr, revenue up 5%

Company says operational performance came amid geopolitical turmoil resulting in supply chain challenges and inflationary pressures

Zydus Lifesciences Q4 profit dips 41% to Rs 397 cr due to higher expenses

The company had posted a consolidated net profit of Rs 679 crore in the same quarter of previous fiscal year, Zydus Lifesciences said in a regulatory filing.

India-developed 'variant-proof' Covid vaccine likely in 2-3 years: Industry

Domestically produced variant-proof jabs are part of a global project to develop vaccines for future epidemics

A first in India: Zydus brings new drug for uncontrolled 'bad' cholesterol

Uncontrolled LDL-c, which poses a major risk of cardiovascular diseases, lacked proper treatment despite patients' lifestyle changes and use of statins

NTAGI meet this week to review vaccine data for 5-12 age group

A senior government official had told Business Standard last week that so far there was no scientific evidence to expand the vaccination programme to young children

DCGI okays emergency use of Zydus' two-jab Covid-19 vaccine for 12 yrs-plus

With this, vaccine will now be administered on day 0 and day 28. Earlier, it was approved as a triple dose on day 0, day 28 and day 56

Covid-19: Zydus gets SEC approval for two-dose regimen of ZyCov-D

Zydus to conduct mixing trials to test vax efficacy after two shots of Covishield/Covaxin

Zydus Lifesciences gets 3 observations from USFDA for Vadodara plant

Zydus Lifesciences on Thursday said the US health regulator has issued three observations after inspecting its Jarod (Vadodara) based manufacturing facility. The US Food and Drug Administration (USFDA) inspected the injectable facility from February 24 to March 10, 2022. The inspection closed with three observations, the drug firm said in a regulatory filing. "We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network," Zydus Lifesciences stated. As per the US health regulator, an FDA Form 483 (observation) is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of Food Drug and Cosmetic (FD&C) Act and related Act.