| |DECEMBER 20258BIOCON UNVEILS PLAN TO MERGE BIOCON BIOLOGICS BY 2026ZYDUS LIFESCIENCES RECEIVES USFDA EIR FOR JAROD, VADODARA PLANTThe Establishment Inspection Report (EIR) issued to Zydus Lifesciences by the U.S. Food and Drug Administration (USFDA) concerning the GMP follow-up inspection at its injectable manufacturing facility in Jarod, Vadodara. This audit was carried out between 25 August-05 September 2025 and the centre had been identified as Voluntary Action Indicated (VAI). This follows a Warning Letter that was issued by the USFDA on 29 August 2024.According to the VAI classification, the facility does not need any additional regulatory measures at the time, which is a significant milestone in the process of enhancing compliance within the facility, which Zydus should achieve. The receipt of EIR offers the basis for when the follow-up inspection is being performed and that the agency has finished reviewing the corrective measures taken by the company.Jarod injectable plant is another important component of the manufacturing network of Zydus Lifesciences and it provides products to controlled markets abroad. The recent regulatory communication enables the firm to proceed with a more stable business operation and, at the same time, advance the quality and compliance systems in the manufacturing activities.The USFDA follow-up review and the previous regulatory inspections have been observed to be aspects that Zydus Lifesciences has been undertaking in its efforts to ensure compliance, which is a continuous process. The EIR and VAI classification will facilitate the work of the company, which consists of keeping consistent production and having the availability of the injectable portfolio to offer to the global markets. POTOP STORIESBiocon Limited has unveiled a major shift. It confirmed plans to fully integrate Biocon Biologics as a wholly owned subsidiary once regulatory and shareholder approvals are cleared.The move marks a pivotal moment for the company as it prepares to streamline operations and sharpen its global biopharma focus.A Governance Council led by Executive Chairperson Kiran Mazumdar-Shaw will guide the transition, supported by a Transition and Integration Management Committee headed by Shreehas Tambe, CEO and Managing Director of Biocon Biologics and Kedar Upadhye will assume the role of Chief Financial Officer. Siddharth Mittal will transition to a broader leadership role within the Biocon Group.Under the proposed structure, Biocon will acquire remaining BBL shares held by Serum Institute Life Sciences, Tata Capital Growth Fund II, and Activ Pine LLP through a stock swap of 70.28 Biocon shares for every 100 BBL shares, valuing the unit at $5.5billion.The company will also buy Viatris' remaining stake for $815 million, splitting payment between $400 million in cash and a share exchange of 61.70 Biocon shares per 100 BBL shares. EY independently determined all valuation ratios.Kiran Mazumdar-Shaw stated, "Bringing Biocon Biologics fully under Biocon marks a transformational milestone for our company. The combined capabilities in biosimilars and generics will provide a differentiated offering across major global markets and enable us to better serve patients, especially in diabetes, oncology and immunology." PO
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