Driven by digital transformation, operational
excellence, and the highest quality standards, we set new benchmarks in commercial-scale
manufacturing for both small and large molecules. With the addition of our first U.S.
based facility, we expanded our global biologics footprint while maintaining a strong
focus on operational efficiency, digital innovation, and quality.
Syngene’ s integrated biologics plant in
Bengaluru supports diverse expression systems, ensuring scalability and flexibility to
meet customer needs.
In the Large Molecule commercial
manufacturing space, our new (acquired from Stelis) 20,000-liter biologics facility,
with a commercial-scale fill-finish unit, will be operational in FY26, offering
customized, plug-and-play manufacturing platforms.
In the Small Molecule commercial
manufacturing space, our Mangaluru’s API facility specializes in complex chemical
synthesis and scale-up, working closely with our Development Services team to ensure
smooth transitions from development to commercial production.
Performance Overview
Manufacturing services continued to gain
momentum, particularly in biologics, with repeat orders from existing customers and
increasing interest from new customers. Strong demand for our capabilities underscores
our ability to deliver high-quality manufacturing solutions that meet global regulatory
standards. Leading global biopharmaceutical companies visited our manufacturing sites to
explore business opportunities with us.
Driving Digital Transformation
We are accelerating digital transformation to
strengthen our position as a preferred outsourcing partner in manufacturing. By
integrating automation, IT solutions, and data analytics, we optimize workflows, enhance
resource allocation and utilization, and ensure regulatory compliance. This
digital-first approach drives efficiency, reduces costs, and delivers mutual benefits
for both our customers and us.
Strategic Growth Initiatives
We are expanding monoclonal antibody
production capacity, enhancing biologics capabilities, and targeting growth in the
animal health sector. Our efforts center on operational excellence, technology-driven
efficiencies, and customer-focused solutions.
Building the ‘Smart Factory’ Ecosystem
By integrating IT and Operational Technology
(OT), we are creating a data-driven Smart Factory ecosystem. Leveraging IoT, MES,
Digital Twins, and AI. This will enable real-time monitoring, predictive maintenance,
and optimized resource allocation, thus enhancing agility, cost efficiency, and quality.
Enhancing Cost Efficiency and Productivity
We implemented digital interventions to
increase throughput and reduce COGS, to meet the rising demand for cost-effective
products. The rollout of a Manufacturing Requirements Planning (MRP) system in FY25 has
improved the visibility of materials across locations and stages.
Commitment to Quality and Operational
Resilience
Our Golden Batch initiative drives process
excellence, supported by paperless batch manufacturing for better efficiency and
traceability. Digital monitoring minimizes deviations and OOS results, optimizing supply
chain planning and ensuring regulatory compliance and customer satisfaction.
Key IT Projects
We are driving digital innovation to enhance
manufacturing efficiency and transparency:
- eBMR for Biologics:
Integrated equipment
with a Distributed Control System (DCS) for automated real-time data capture.
Transition to a fully digital eBMR system is planned post-customer approval.
- Warehouse Management System:
Implemented
a QR code-enabled system for real-time inventory tracking and material management.
Solution development and unit testing are complete.
- Smart Inventory Dashboards:
Developed
real-time digital dashboards using Six Sigma methods to improve inventory
visibility, material aging, and stock management across biologics plants.
Enhancing Productivity, Efficiency,
and Speed
In FY25, the Biologics unit
implemented initiatives to boost productivity, improve efficiency, and shorten
delivery timelines. These efforts led to a 13% year-on-year yield improvement
over FY24, demonstrating our focus on process optimization and continuous
improvement.
Awards and Recognitions for Biologics Unit
Three Gold Awards from
the Quality
Circle Forum of India (QCFI), Bengaluru Chapter for outstanding Six
Sigma
projects.
Recognition for
participation in the ASQ South Asia Team
Excellence Award (SATEA), demonstrating our capabilities in
team-based
excellence initiatives.
Three Excellence Awards
at the National Convention on Quality
Concepts (NCQC), highlighting our commitment to quality and
innovation.
EFQM Global Certification in
Business Excellence: Three team members
completed the European Foundation for Quality Management (EFQM) Global
Certification Program, hosted by the Confederation of Indian Industry (CII) as
part of the CII-EXIM Bank Award for Business Excellence.
Strengthening Capabilities with Our
First
U.S. based Manufacturing Facility
In FY25, Syngene marked a significant
milestone by acquiring our first biologics manufacturing facility in Baltimore,
Maryland, United States. This expansion enhances our global presence and
reaffirms
our commitment to delivering flexible, end-to-end solutions across regions.
Syngene U.S. Inc.’s state-of-the-art
facility, adds multiple monoclonal antibody (mAb) production lines boosting our
biologics capacity. With this addition, our total single-use bioreactor capacity
reaches 50,000L, enhancing our capabilities in large molecule discovery,
development, and manufacturing capabilities.
This investment ensures seamless
supply
continuity through our four integrated sites in India and North America,
supporting
clinical and commercial human and animal health programs. Our U.S. presence
reflects
a long-term commitment to the market, which is expected to create jobs and
strengthen the region’s biological manufacturing infrastructure. This expansion
reinforces our goal to provide customers with global scalability, quality, and
scientific expertise.
