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

Securities in F&O ban :Balrampur Chini Mills, Aarti Industries, Aditya Birla Fashion and Retail, Birlasoft, Chambal Fertilisers and Chemicals, GNFC, Granules India, Hindustan Copper, Indian Energe Exchange, India Cements, NALCO, RBL Bank, Sun TV Network Stocks to watch : Shyam Metalics and Energy's wholly-owned subsidiary, Shyam Sel and Power (SSPL) has acquired a 100% stake in SMEL Steel Structural, a promoter group company, for total consideration of Rs 1 lakh. KEC International secured new orders of Rs 1,079 crore in transmission & distribution (T&D) and cables businesses. Zydus Lifesciences' wholly owned subsidiary, Zydus Animal Health and Investments has entered into share purchase and share subscription agreement (SPSSA) with Perfect Day to acquire 50% stake in Sterling biotech. Dr Reddy's Laboratories said that the US drug regulator has issued Form 483, with three observations after inspecting its Andhra Pradesh manufacturing facility. Ashoka Buildcon has emerged as the lowest bidder (L-1) for a project worth Rs 478 crore awarded by Mumbai Metropolitan Region Development Authority (MMRDA). Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam. Lemon Tree Hotels signed a license agreement for a 175- room property in Surat. Akum Drugs and Pharmaceutical reported consolidated net profit of Rs 60.17 crore in Q1 FY25 as compared with net loss of Rs 188.22 crore posted in corresponding quarter last year. Revenue increased 5.08% YoY to Rs 1,019.11 crore in Q1 FY25. Transport Corporation of India board approved shares buyback for up to Rs 160 crore at Rs 1200 per share.Powered by Capital Market - Live

Sterling Biotech is one of the leading producers of Pharmaceutical Gelatine, Di-calcium phosphate and some APIs. It operates 2 (two) manufacturing facilities in Gujarat. Its turnover was Rs 454.89 crore for FY24. The company will acquire 32.16 crore equity shares of Rs 1 each for total consideration of Rs 550 crore subject to certain adjustments with respect to cash and debt. Perfect Day Inc., a Temasek portfolio company will sell its around 50% shareholding in Sterling Biotech. Post this transaction, Sterling Biotech will become a 50:50 joint venture (JV) with equal representation on the board. The JV will establish a manufacturing facility to manufacture fermented animal free protein to cater to the global markets. The JV will accelerate the production of high-quality and ecofriendly protein products, reduce environmental impact, and cater to the growing consumer demand for fermentation-based and ethically sourced nutrition. The acquisition will also mark Zydus' foray into specialised biotech products for health and nutrition, specifically catering to consumers who prefer animal-free protein or suffer from lactose intolerance. Perfect Day's precision-fermented protein is found in ice creams, cream cheese, sports nutrition products, and baked goods with high functionality benefits and lower environmental impact. The said acquisition of sale shares is expected to be completedwithin perion of 60 working days from date of execution of the SPSSA. Dr. Sharvil Patel, managing director, Zydus Lifesciences, said, 'We are dedicated to promoting growth through partnerships and are consistently exploring new collaborations to position India as a premier global supply chain hub. We are excited to join forces with Perfect Day and create a win-win combination that leverages both our strengths and expertise to create value for the consumers.' Narayan TM, Interim CEO, Perfect Day said, 'This partnership allows Perfect Day to significantly boost its capabilities to meet the demands of the fast-growing global market. We deeply value our collaboration with Zydus and believe this joint venture will allow both parties to benefit from each other's expertise.' Zydus Lifesciences is a discovery-driven, global lifesciences 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 quareter ended 30 June 2024. The counter declined 2.57% to ends at Rs 1,178.65 on Friday, 23 August 2024.Powered by Capital Market - Live

Zydus Lifesciences through its wholly owned subsidiary, and Perfect Day Inc., a Temasek portfolio company (Perfect Day) have signed an agreement wherein Perfect Day will sell its ~50% shareholding in Sterling Biotech (SBL). Post this transaction, Sterling Biotech will become a 50:50 Joint Venture (JV) with equal representation on the Board. The JV will establish a state-of-the-art manufacturing facility to manufacture fermented animal free protein to cater to the global markets. The JV will accelerate the production of high-quality and ecofriendly protein products, reduce environmental impact, and cater to the growing consumer demand for fermentation-based and ethically sourced nutrition. This partnership marks a significant step forward in the global effort to transform the food industry and promote a healthier planet. The acquisition will also mark Zydus' foray into specialised biotech products for health and nutrition, specifically catering to consumers who prefer animal-free protein or suffer from lactose intolerance. Perfect Day's precision-fermented protein is found in ice creams, cream cheese, sports nutrition products, and baked goods with high functionality benefits and lower environmental impact. This transaction between Perfect Day and Zydus underlines the importance of the emerging global markets for environmentally friendly and sustainable products. Perfect Day will significantly enhance its technological capabilities in India as part of its emerging market growth strategy, while Zydus will continue to leverage its strong manufacturing and commercial expertise. Through this manufacturing partnership both the parties reaffirm their commitment of making India a bright spot in global supply chain. SBL is currently engaged in manufacturing and selling of fermentation-based API products and gelatine. With a clear vision of focussing on animal free protein products the JV partners will also take a strategic view on API and gelatine business.Powered by Capital Market - Live