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

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.

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.

GVK BIO’s manufacturing facility has approvals from worldwide regulatory authorities like USFDA, EDQM, PMDA, MFDS 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

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.

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

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

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