Sudeep Pharma has secured approval from the Gujarat Food and Drug Control Administration (FDA) to commence manufacturing operations at its new greenfield pharmaceutical facility at 179 Nandesari, Gujarat, paving the way for a major capacity expansion.

 

The facility, with an installed annual capacity of 51,200 metric tonnes (MT), will strengthen the company's manufacturing capabilities across pharmaceuticals, food and nutrition, and specialty ingredients. The approval also positions Sudeep Pharma to address rising demand from domestic and international customers.

 

Commercial supplies from the new facility are expected to begin in H2 FY27, subject to the completion of customer qualification processes.

 

The approval marks a key milestone in the company's expansion strategy, clearing the way to bring additional manufacturing capacity online while meeting applicable quality and regulatory requirements.

 

Around 60% of the facility's capacity will serve Sudeep Pharma's existing pharmaceutical, food and nutrition portfolio. The remaining capacity will be directed towards newer product categories, including phosphates, glycinates, gluconates and citrates.

 

Beyond expanding overall manufacturing capacity, the Nandesari facility will provide dedicated capacity for higher-value ingredients, supporting Sudeep Pharma's push towards portfolio diversification and a stronger presence in regulated markets.

 

The additional infrastructure is particularly significant for emerging, high-value molecules such as bisglycinates, where capacity constraints at the company's existing mother plant had limited expansion. The new facility is expected to enable higher production volumes, help meet growing customer requirements and allow the company to pursue opportunities in specialised ingredients.

 

The approval also enables Sudeep Pharma to accelerate customer qualification processes and facility audits, paving the way for the onboarding of new customers and expansion of relationships with existing ones.

 

Commenting on the development, Sujit Bhayani, Managing Director, Sudeep Pharma Limited, said: "The FDA approval for our 179 Nandesari greenfield facility marks an important milestone in our growth journey, enabling us to commence manufacturing operations and unlock significant additional capacity. 

 

"It strengthens our ability to serve a wider customer base across pharmaceutical, food and nutrition segments in India and international markets. With the approval in place, we can now accelerate customer qualification processes and audits at the facility, facilitating the onboarding of both new and existing customers.

 

The new facility adds to Sudeep Pharma's manufacturing infrastructure and is expected to support its next phase of growth by expanding capacity, broadening its product portfolio and strengthening its ability to serve customers across domestic and international markets.