Contract Manufacturing Services

1. Contract Manufacturing Services

2. GVK BIO offers long term Contract Manufacturing services right from strategic partnerships in development, validations, DMF filing and commercial manufacturing of Active Pharmaceutical Ingredients (APIs)/advanced intermediates to APIs. We have flexible business models to support various client needs: Process optimisation, technology transfer, validations and DMF filing followed by manufacturing upon commercialization. Technology absorption, validations, DMF filing support and Commercial manufacturing. Technology absorption and commercial manufacturing.

3. We have a diverse scientific team with expertise to meet API and advanced intermediate needs centred on the rapid synthesis of supplies. Our project management and technical teams ensure a seamless technology transfer of processes, as projects advance from feasibility to DMF filing through complete process optimisation, process validations and stability program. We can optimise and develop robust and cost efficient processes for large scale manufacturing using environment friendly routes under GMP conditions with globally acceptable regulatory guidelines.

4. The combination of development experience, manufacturing infrastructure and regulatory expertise makes GVK BIO a preferred strategic partner for reliable, cost effective, long term contract manufacturing partners for APIs/advanced intermediates.

5. GVK BIO’s manufacturing facility has approvals from worldwide regulatory authorities like USFDA, EDQM, PMDA, KFDA and WHO GMP. These accreditations facilitate faster and easier approvals of DMFs/dossiers for our business partners. • Our dedicated late stage development teams have extensive experience in the following: • Commercial synthesis route scouting • Commercial process development and optimisation through DoE and QbD • Stepwise unit operation studies and defining critical process parameters • Impurity profiling and define control measures • Documentation for all kinds of regulatory filings

6. Our commercial manufacturing facility is co-located with our pilot plant, providing end-to-end API service from feasibility phase in R&D to commercial launch. This integration eliminates the need for tech transfers when a project advances through each development phase, allowing us to help reduce delivery time while providing cost-effective services. Our facilities can scale up all types of reactions, including asymmetric hydrogenations, air and water sensitive metal catalytic reactions, high temperature, high pressure, cryogenic and oxidations reactions.

7. The manufacturing facility has wide range of equipment: • Reaction vessels starting from capacity 20 L to 6000 L • Material of construction: stainless steel, glass lined, glass, halar coated, hastelloy-C, etc. • Utilities ranging from -70°C to +200°C • Supporting equipment to handle all kinds of unit operations

8. GVK BIO’s manufacturing team has expertise to handle a wide range of operating conditions with flexible scales. Over the years we have exhibited exemplary process and technology capabilities for NCEs and commercial production of advanced intermediates/APIs. Our process development, technology transfer and commercial execution teams collaborate seamlessly to provide best-in-class concept to commercialisation timelines. • Salient features: • Driven by the need to design an economic and robust process with defined in-process controls to yield optimum and desired quality • Provide engineering support from initial stages of product development by identifying process specific facility requirements to deliver a validated process at designated scale • Observe and assimilate process operations and all critical parameters and systematically execute under guidelines charted by Quality Management Systems

9. Manufacturing Infrastructure: • GMP compliant six manufacturing blocks with varied capacities ranging from 20 L – 6,000 L • Total reaction volume capacity: 170,000 L • MOC: All glass, glass lined, SS & Hastelloy reactors • Hydrogenation capabilities: 50 L to 2,000 L, upto 25 bar and large scale column chromatography • Class 100,000 cleanroom, kilo labs and powder processing area • Stability chambers for conducting stability studies at all conditions

10. About GVK BIO: Established in 2001, GVK BIO is one of Asia’s leading life sciences service organizations. At GVK BIO, we blend science with people and technology to help accelerate drug discovery and development for more than 400 clients globally across small and large molecule platforms. Our clients include the world’s top 10 corporations in the field of Pharmaceutical, Biotechnology and Agrochemicals along with leading Academic institutions. For further information, please contact: