Syngene International Ltd Share Price – NSE  / BSE

Healthcare, Small Cap

The state-of-the-art facility, located in Baltimore, Maryland, was acquired by Syngene USA Inc., a wholly owned subsidiary of Syngene, from Emergent Manufacturing Operations Baltimore, LLC, a subsidiary of Emergent BioSolutions Inc.

The newly acquired site is equipped with multiple monoclonal antibody (mAb) manufacturing lines and will increase Syngene’s single-use bioreactor capacity to 50,000L, enhancing its ability to support large molecule discovery, development, and manufacturing services. The facility will play a crucial role in Syngene’s global operations, providing continuity of supply alongside the company’s existing facilities in India and North America.

With the acquisition, Syngene strengthens its ability to serve both human and animal health market segments, offering a range of services, including cell line development, process optimization, and clinical and commercial supply. This expansion highlights Syngene’s strategic commitment to the U.S. market and aims to foster deeper economic ties between India and the United States, benefiting both countries' life sciences sectors.

The total investment in the U.S. facility is estimated at $50 million, including the acquisition cost of $36.5 million and expenses related to making the site operational. The acquisition is expected to close in March 2025, pending customary closing conditions. The upgraded Baltimore facility, strategically located near key biotech hubs in the Northeast, is anticipated to be operational for client projects by the second half of 2025.

The firm anticipates the site will see demand from innovative U.S. mAb developers requiring direct access for onshore production, as well as international innovators who want a U.S.-based manufacturing option. This complements the capabilities and capacity available across its facilities in Bengaluru. As part of the agreement, Emergent BioSolutions itself has the right to secure manufacturing capacity from the facility in the future, representing offtake potential from U.S.-based innovators. It will also support the growing animal health segment, in which a U.S. site is often a key client requirement.

The company said that investment in its first facility in the United States marks a strategic commitment to the U.S. market, with significant benefits for the local economy and the broader life sciences industry. The facility is expected to create jobs, stimulate local economic activity, and strengthen domestic biologic manufacturing capabilities while also contributing to pharmaceutical innovation and supply chain resilience. This investment highlights the potential for deeper economic collaboration between India and the United States, fostering sustained economic growth and advancing the shared goal of bolstering critical healthcare infrastructure.

Peter Bains, CEO Designate, Syngene International, said, “With one of the largest biologics R&D teams and commercial scale manufacturing capabilities in both India and the USA, we now offer a compelling and flexible solution for global pharma and biotech customers. This investment will enable Syngene to cater to growing client requirements in an expanding market. It will also provide clients access to the collective service capability of multiple geographic sites, scientists and experience.”

Alex Del Priore, Senior Vice President – Development & Manufacturing Services, Syngene International, said, “This facility is a significant milestone for Syngene and comes in response to growing client demand in the United States, the fastest-growing biologics market. It strengthens our offering for animal health clients looking for USDA approval for their products. Most importantly, it increases the options we can offer our global customers, providing commercial-scale biologic manufacturing capabilities across our global network and will be underpinned by existing key client projects.”

Deepak Jain, CFO, Syngene International, said, “The investment will be synergistic with expected additional process development work that will be executed in India while manufacturing can be done in the US. The investment will be fully funded through internal accruals and cash. The company will continue to maintain a robust balance sheet, a low debt profile, and a comfortable safety margin for debt covenants post this investment. As we ramp up utilization, we expect asset turnover to grow to 1x in less than 5 years, with EBIT margins expected to be in line with the company average from FY30 and positively contribute to the bottom line. The acquisition will not materially impact the current financial guidance given for fiscal year 2024–2025. In the short term, we expect a minor dilution of operating margins as a result of costs to be incurred in this facility.”

Syngene International is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors.

The company reported 17.58% increase in consolidated net profit to Rs 131.1 crore in Q3 FY25 as compared with Rs 111.5 crore in Q3 FY24. Revenue from operations jumped 10.57% YoY to Rs 943.7 crore in Q3 FY25.

The counter rose 0.29% to Rs 680 on the BSE.

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Syngene International (Syngene) today announced the acquisition of its first biologics site in the USA - fitted with multiple monoclonal antibody (mAbs) manufacturing lines.

The state-of-the-art biologics facility, acquired by Syngene USA Inc., a wholly owned subsidiary of Syngene, from Emergent Manufacturing Operations Baltimore, LLC (a subsidiary of Emergent BioSolutions Inc.), will expand Syngene's growing global biologics footprint to better serve its customers across both human and animal health market segments. The new site will increase Syngene's total single-use bioreactor capacity to 50,000L for large molecule discovery, development, and manufacturing services. Additionally, it will provide Syngene's customers with continuity of supply from its four development and manufacturing facilities located in India and North America, offering services ranging from cell line development, process optimization and both clinical and commercial supply.

Syngene's investment in its first facility in the United States marks a strategic commitment to the US market, with significant benefits for the local economy and the broader life sciences industry. The facility is expected to create jobs, stimulate local economic activity, and strengthen domestic biologics manufacturing capabilities, while also contributing to pharmaceutical innovation and supply chain resilience. This investment highlights the potential for deeper economic collaboration between India and the United States, fostering sustained economic growth and advancing the shared goal of bolstering critical healthcare infrastructure.

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In a regulatory filing, the company informed that the USFDA conducted a pre-approval and cGMP inspection of commercial manufacturing activities for the US market at the Bengaluru facilities from 10 February 2025 to 20 February 2025.

On conclusion of the inspection, the USFDA issued Form 483 with 5 (Five) observations.

The company will work closely with USFDA and remains committed to addressing these observations comprehensively within the stipulated time, Syngene International said in a statement.

Syngene International is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors.

The company reported 17.58% increase in consolidated net profit to Rs 131.1 crore in Q3 FY25 as compared with Rs 111.5 crore in Q3 FY24. Revenue from operations jumped 10.57% YoY to Rs 943.7 core in Q3 FY25.

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Syngene International today announced that Jonathan Hunt has stepped down from his role as MD&CEO as well as from the Board of Directors to pursue other opportunities in due course. Consequent to this, the Board has appointed Peter Bains as the CEO Designate of Syngene. Both changes are effective immediately, i.e., 10 February 2025.

Peter Bains has over three decades of experience in the biotech and pharmaceutical industry. Peter also served as CEO of Syngene from June 2010 to March 2016 and was instrumental in creating a strong foundation for the business and taking it public in 2015. Peter's deep domain experience, knowledge, and familiarity with the business, together with his leadership acumen makes him eminently qualified to step into this role.

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