Partnering for investigational to commercial-scale development programs

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. We cater to several industries including pharmaceuticals, specialty chemicals, agrochemicals, polymers, oligonucleotides, animal health, and consumer products. Our team excels at resolving complex scientific problems with a systematic approach and in a time-bound manner while assuring the quality of all processes and products. 

Capabilities

Syngene’s development capabilities include advancing highly potent active pharmaceutical ingredients (HPAPI) and oligonucleotides with therapeutic and diagnostic applications, from laboratory to manufacturing scale. Our expertise also includes working with performance chemicals and specialty materials using synthetic organic chemistry and polymer chemistry. 

We are proficient in developing robust chemical processes, and can scale-up a product of interest rapidly. We integrate analytical services such as method development, validation, transfer, and reference standard qualification throughout the development process. Our experts are also well-versed in providing necessary regulatory support for clients. 

Resources

Syngene has a strong team of more than 900 experienced process chemists, process engineers, analytical scientists, safety professionals, and manufacturing experts with an unparalleled track record. Our scientists have significant training and experience across synthetic organic chemistry, analytical chemistry, process chemistry, process safety, and engineering. The chemical development team is supported by experts from our supply chain, warehouse, quality control, and quality assurance teams.

Our scientists have been named as co-inventors for their contribution towards solving various chemistry problems while partnering with clients. This is a strong testament to our ability to add value to a partner’s program. 

Infrastructure

Syngene’s laboratories are fitted with fume hoods in multiple suites that help scientists and engineers develop robust and safe processes for manufacturing. Our state-of-the-art process engineering and process safety laboratories, help in making processes rich with scientific data for execution at every scale. Chemical development team is also equipped with new age technologies such as flow chemistry, photo chemistry, high potent API, software-based toxicity evaluation, statistical and QbD-based process development, quantitative risk assessment, and green chemistry.

We manufacture compounds for various industries at facilities that are appropriate to the intended end application. Our facilities have been inspected by global regulatory authorities such as the US food and drug administration (FDA), European medicines agency (EMA), and pharmaceuticals and medical devices agency (PMDA). Besides regulatory authorities, our facilities have also been inspected by qualified personnel, clients, and third-party auditors. Syngene’s dedicated cGMP facility is certified by the drugs controller general of India (DCGI) as well as by independent certifying agencies like TUV Nord.