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

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Scopolamine Transdermal System 1 mg/3 days. (USRLD: Transderm Scop Transdermal System ' 1 mg/3 days). This is the fifth ANDA approval for Zydus in the transdermal portfolio, leveraging the group's strengths in the manufacturing of complex drug device dosage forms. Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness. The Scopolamine Transdermal System will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad. Scopolamine Transdermal System 1 mg/3 days had annual sales of USD $69.6 mn in the United States (IQVIA MAT June 2024). Powered by Capital Market - Live

The warning letter summarizes violations of current good manufacturing practice (cGMP) regulations but does not include any data integrity related violations. Earlier on 18 July 2024, the company's Jarod facility had received official action indicated (OAI) status by the USFDA .This site was inspected by USFDA from 15 April to 23 April 2024. The contents of the warning letter will be made public by the USFDA in due course, said the firm. The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility, it added Meanwhile, the company said that it has received a final approval from the USFDA to market Scopolamine Transdermal System. Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness. The drug is equivalent to reference listed drug Transderm Scop Transdermal System. This is the fifth abbreviated new drug application (ANDA) approval for Zydus in the transdermal portfolio, leveraging the group's strengths in the manufacturing of complex drug device dosage forms. The pharma company said that the drug will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad. According to IQVIA MAT June 2024, Scopolamine Transdermal System had annual sales of $69.6 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 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 shed 0.50% to Rs 1,126.55 on the BSE.Powered by Capital Market - Live

Zydus Lifesciences has received a Warning Letter issued by the USFDA relating to its Injectables manufacturing facility at Jarod near Vadodara. The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. The Warning Letter does not contain any data integrity related violations. This site was inspected by USFDA from 15 April to 23 April 2024. Powered by Capital Market - Live

Zydus Lifesciences announced that its wholly owned subsidiary, Zydus Animal Health and Investments has completed the acquisition of 50% stake of Sterling Biotech from Perfect Day Inc. on 29 August 2024. Powered by Capital Market - Live

The approved drug is a reference listed drug of Gocovri (amantadine) extended-release capsules, 68.5 mg and 137 mg. The Amantadine extended-release capsules are indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ-II, India. This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules, 68.5 mg. 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. Powered by Capital Market - Live