Syngene International is a contract research, development and manufacturing organisation (CRDMO) serving the global pharmaceutical, biotech, nutrition, animal health, consumer goods and speciality chemical sectors.

We aim to build strategic, long-term relationships with our clients and partners by offering a range of research and development services, from initial research programme planning to candidate selection, pre-clinical and clinical development, and manufacturing.

Fully regulated and compliant facilities for research and development

Syngene operates world-class facilities for discovery, development and manufacturing activities, covering a total of two million square feet.

We aim to help biotechnology companies of all sizes pursue scientific breakthroughs.
Syngene serves pharmaceutical, biotechnology, nutrition, animal health, consumer goods and speciality chemical companies worldwide.
We provide a range of integrated research services for the clinical development and manufacturing process.
We offer expertise in the principles of Quality by Design (QbD).
Syngene is headquartered in Bangalore, India, with research and development facility and multiple manufacturing sites.
Syngene operates current good manufacturing practice (cGMP) compliant facilities for clinical supplies.
Our services ensure that projects comply fully with regulatory standards.

Our state-of-the-art research facilities are certified according to ISO 9001: 2008, ISO 14001: 2004 and OHSAS 18001: 2007 standards. Our animal facilities are good laboratory practice (GLP) certified by Indian authorities and accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC). Syngene is also India’s only GLP viral clearance service provider as certified by the Indian Government’s National GLP Compliance Monitoring Authority.

Our labs are certified by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Product Development and Management Association (PDMA).

A strong corporate governance framework focused on client satisfaction, quality, safety, ethics and integrity makes us the partner of choice for all research-related services. We currently have more than 400 active clients worldwide and hold more than 400 patents with clients.

Comprehensive services for biopharmaceutical companies

Syngene is an innovation-led CRDMO offering both standalone and integrated scientific services, from early discovery to commercial supply, for therapeutics of all sizes. We serve biotechnology companies, non-profit institutions, academic centres and government organisations.

We help leading pharmaceutical and biotechnology companies navigate regulatory requirements and get their products to market more quickly. We apply our scientific expertise to deliver innovation in segments beyond life sciences, including speciality chemicals and consumer products.

Syngene provides high-quality, customised and cost-effective services that comply fully with regulatory standards, no matter the scale or scope of the client’s project. Our discovery services cover early-stage research, from target identification to delivering drug candidates for further development.

Full-service drug development and manufacturing services

Syngene’s development services encompass activities from pre-clinical to clinical trials, including drug substance development, drug product development, and other associated services to demonstrate the selected drug candidate’s safety, tolerability, and efficacy.

Our manufacturing services for small molecules and biologics include current good manufacturing practice (cGMP) compliant facilities for clinical supplies, registration batches and commercial volumes through our active pharmaceutical ingredient (API) manufacturing plant and disposable biologics manufacturing facility.

Syngene operates dedicated research and development (R&D) facilities for strategic clients, providing exclusive access to research teams, infrastructure, and project management to support our clients’ R&D requirements.

About Syngene

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. Syngene’s more than 6,000 scientists offer both skills and the capacity to deliver great science, robust data security, and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.

Syngene provides a combination of dedicated research facilities for Amgen, Baxter, and Bristol-Myers Squibb, as well as specialist discovery, development, and manufacturing facilities covering 2.2 million square feet in total. We work with biotech companies pursuing leading-edge science in addition to multinationals, including GSK, Zoetis and Merck KGaA. Syngene USA is our wholly owned US-based subsidiary.