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Syngene

Contract Research, Development and Manufacturing Organisation

Syngene offers contract research, development and manufacturing services for biopharmaceutical and other relevant industries.

Address
Biocon Park, SEZ,
Bommasandra Industrial Area – Phase-IV,
Jigani Link Road, Bangalore 560 099,
India

Syngene International is an integrated 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 integrated research and development services, from the initial research programme planning to candidate selection, pre-clinical and clinical development, and manufacturing.

Fully regulated and compliant facilities for research & development

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

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 operates one research campus and two sites in Bangalore, India.
We aim to help biotechnology companies of all sizes pursue scientific breakthroughs.
Our services ensure that projects comply fully with regulatory standards.
Syngene operates current good manufacturing practice (cGMP) compliant facilities for clinical supplies.

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 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 413 patents with clients.

Integrated services for Biopharmaceutical companies

Syngene is an innovation led CRDMO offering integrated scientific services, from early discovery to commercial supply, for small molecules and biologics (large Molecules) of all sizes.

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.

We provide high-quality, customised and cost-effective services that comply fully with regulatory standards, no matter the scale or scope of the client’s project.

Comprehensive services to expedite drug discovery and development

Syngene provides a full range of services for biotechnology companies, non-profit institutions, academic centres, and government organisations.

Our discovery services cover early-stage research, from target identification to delivering drug candidates for further development.

Our 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.

Syngene’s manufacturing services for small and large molecules 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.

We operate 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 is based in Bangalore, India, where we have a research campus and two sites. We also operate a research campus in Hyderabad and a manufacturing campus in Mangalore. Syngene USA is our wholly owned US-based subsidiary.

Our team of more than 4,700 scientists has the skills and experience to deliver optimal science, robust data management, intellectual property (IP) security and quality manufacturing to reduce time-to-market and the cost of innovation.

Chemical Development

Syngene provides comprehensive process research and development services as well as current good manufacturing practices (cGMP) manufacturing capacities to help clients with investigational to commercial-scale development programs.

Formulation Development

Syngene offers formulation development services to help clients determine optimal dosage levels for therapeutic formulations in oral solid, liquid, and injectable forms. Our integrated services extend to new chemical entities (NCE), late-phase product development, and over-the-counter products with a focus on quality, speed, and cost-efficiency.

Analytical Development

Syngene’s analytical development services team analyses small and large molecules using a variety of spectroscopic, chromatographic, and physiochemical techniques.

Clinical Development

Syngene’s clinical development services team enables early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.

Biologics Development and Manufacturing

Syngene is at the Heart of Biologics, offering integrated services across the drug discovery, development and manufacturing continuum. As a fully integrated custom biomanufacturer, our solutions include mammalian and microbial capabilities for clinical and commercial supplies.

Syngene International Corporate Video

We are an innovation-led, contract research, development & manufacturing organization offering integrated scientific services from early discovery to commercial supply.

Syngene’s Large-Scale API Manufacturing Plant

State-of-the-art multi-product, multi-client contract manufacturing facility located at Mangalore Special Economic Zone (MSEZ) spread across a sprawling 46 acre campus. Plant designed to support large-scale API and advanced intermediate manufacturing

Syngene Signs Ten-Year Biologics Manufacturing Agreement with Leading Animal Health Company Zoetis

Syngene International today announced the signing of a ten-year agreement with leading animal health company, Zoetis, to manufacture the drug substance for Librela® (bedinvetmab), a first-in-class monoclonal antibody used for treating osteoarthritis in dogs. Launched in Europe, the UK and Switzerland, the product won ‘Best new companion animal product’ by IHS Markit Connect in 2021 for its transformational impact on pain relief for canines suffering from this debilitating condition.

19 July 2022

Corporate Office

Biocon Park, SEZ
Bommasandra Industrial Area – Phase-IV
Jigani Link Road, Bangalore 560 099
India

Clinical Development Services

Semicon Park, Tower 1
Electronic City – Phase-II Hosur Road
Bangalore 560 100
India

RT-PCR Testing Centre

No.39 A, Near Semicon Park
Electronic city, Phase II Hosur Road
Bengaluru 560 100
India

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