Fludrocortisone Acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome. The drug will be produced at the Group's manufacturing site at Moraiya, Ahmedabad. According to IQVIA MAT July 2024, Fludrocortisone acetate tablets generated annual sales of $19.9 million in the United States. The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The pharma company's consolidated net profit surged 30.64% to Rs 1,419.9 crore on 20.77% increase in revenue from operations to Rs 6,207.5 crore in Q1 FY25 over Q1 FY24. Shares of Zydus Lifesciences fell 0.19% to Rs 1,019 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg (USRLD: Florinef Tablets, 0.1 mg). Fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome. Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad. Fludrocortisone acetate tablets had annual sales of USD 19.9 mn in the United States (IQVIA MAT July 2024).Powered by Capital Market - Live

Zydus Lifesciences has formalized the Memorandum of Agreement (MoA) with Indian Council of Medical Research (ICMR) to initiate Phase 2 clinical trials of Desidustat in patients with Sickle Cell Disease. This Phase IIa, double blind, randomized, placebo controlled, parallel, multi-centre, proof-of-concept study, co-funded and co-monitored by INTENT, Indian National Clinical Trial and Education Network, Clinical Studies and Trial Unit, Division of Development Research, ICMR, will evaluate the efficacy and safety of Desidustat oral tablet for treatment of sickle cell disease. Proportion of patients with Hb response (defined as '' 1 g/dL increase in Hb from baseline) compared to placebo will be measured at week 4 and week 8 as the primary end-point. The trial will also evaluate Key Secondary Endpoints including Mean change in haemoglobin, proportion of patients requiring blood transfusions, proportion of patients experiencing vaso-occlusive crisis and mean change in percentage of HbSS. Pankaj Patel, Chairman of Zydus Lifesciences, mentioned that ''Public-private partnerships in the healthcare sector is essential to deliver novel drug to achieve the goals of the National Sickle Cell Anaemia Elimination Mission. The initiation of this study reaffirms hope for the 20 million Sickle Cell affected patients in the country for a high potential novel treatment.'' Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg (USRLD: Invega Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg). Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants. Paliperidone extended-release tablets will be produced at the Group's manufacturing site at SEZ, Ahmedabad. Paliperidone extended-release tablets had annual sales of USD XXX 47.1 in the United States (IQVIA MAT July 2024). Powered by Capital Market - Live

Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants. The drug will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad. The group now has 400 approvals and has so far filed over 465* ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The pharma company's consolidated net profit surged 30.64% to Rs 1,419.9 crore in Q1 FY25 as compared to Rs 1,086.9 crore posted in Q1 FY24. Revenue from operations jumped 20.77% year on year (YoY) to Rs 6,207.5 crore in the quarter ended 30 June 2024. Shares of Zydus Lifesciences fell 0.86% to Rs 1056 on the BSE.Powered by Capital Market - Live

Zydus Lifesciences has received the EIR report from the USFDA for the inspection conducted at its transdermal patch manufacturing facility located at Pharmez, Ahmedabad. This facility underwent an inspection from 15 to 19 July 2024 and has been classified as Voluntary Action Indicated (VAI). Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Enzalutamide Capsules, 40 mg (USRLD: Xtandi' Capsules, 40 mg). Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer. Enzalutamide Capsules will be produced at the Group's manufacturing site at Moraiya, Ahmedabad. Enzalutamide capsules, 40 mg had annual sales of USD 869.4 mn in the United States (IQVIA MAT July 2024). Powered by Capital Market - Live

Zydus Lifesciences Ltd fell for a fifth straight session today. The stock is quoting at Rs 1044.6, down 3.27% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is up around 0.06% on the day, quoting at 25392.05. The Sensex is at 83172.83, up 0.27%.Zydus Lifesciences Ltd has eased around 12.41% in last one month.Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has increased around 2.13% in last one month and is currently quoting at 23025.2, down 0.76% on the day. The volume in the stock stood at 20.64 lakh shares today, compared to the daily average of 35.34 lakh shares in last one month. The benchmark September futures contract for the stock is quoting at Rs 1046.5, down 3.26% on the day. Zydus Lifesciences Ltd jumped 67.2% in last one year as compared to a 27.59% rally in NIFTY and a 47.81% spurt in the Nifty Pharma index.The PE of the stock is 24.86 based on TTM earnings ending June 24.Powered by Capital Market - Live

The Board of Zydus Lifesciences at its meeting held on 17 September 2024 has approved a Business Transfer Agreement (BTA) to purchase the API business (the Target Business) of Sterling Biotech (SBL), on a going concern basis, on slump sale basis, without values being assigned to individual assets and liabilities, on cash-free and debt-free basis at a pre-defined lump-sum consideration of Rs. 84 crore. The Target Business of SBL consists of a portfolio of fermentation-based API products like Lovastatin, Daunorubicin, Doxorubicin and Epirubicin.Powered by Capital Market - Live

Zydus Lifesciences announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit), an innovation driven biopharmaceutical and healthcare company, for gadobutrol injection (generic version of GADAVIST) and gadoterate meglumine injection (generic version of DOTAREM') for the US market. As per the terms of the agreement, Viwit will be responsible for ANDA submission, manufacturing and supplying the generic versions of GADAVIST and DOTAREM', following the receipt of requisite regulatory approval. Zydus will exclusively market, distribute, and sell these products in the US market. Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus' injectable portfolio for the US market. The total addressable market opportunity for gadobutrol injection is estimated at US$ 120 million, and for gadoterate meglumine injection at US$ 117 million in the US market (as per IQVIA MAT Jul - 2024). Powered by Capital Market - Live