Sudeep Pharma's Nandesari Plant in Gujarat Clears US FDA Review

Sudeep Pharma Limited has confirmed that the US Food and Drug Administration has cleared its greenfield plant at 179 Nandesari in Gujarat, permitting manufacturing to begin at the site. The plant carries an installed annual capacity of 51,200 metric tonnes. Sudeep Pharma stated that the site is designed to serve demand in the pharmaceutical, food, and nutrition industries, with commercial supplies planned for the second half of fiscal year 2027 once customer qualification work is finished.

How the New Capacity Will Be Deployed

Of the total 51,200 MT, roughly 60 percent is earmarked for the company's current Pharma and Food & Nutrition portfolios. The balance will go toward newer categories: phosphates, glycinates, gluconates, and citrates.

The design also allows for high-value ingredients and new-age molecules, among them bisglycinates. The company said this feature will broaden its product range and deepen its footprint in regulated markets. The added capacity is expected to bolster operations across its three core segments, Pharma, Food & Nutrition, and Specialty Ingredients, and help the company serve growing demand in India and abroad.

Leadership Response to the Clearance

Sujit Bhayani, the company's managing director, said the FDA approval for the 179 Nandesari greenfield facility is an important milestone in its growth journey, enabling manufacturing to commence and unlocking significant additional capacity.

He added that it strengthens the company's ability to serve a wider customer base across pharmaceutical, food, and nutrition segments in India and international markets. With the clearance in hand, Sudeep Pharma said it will now move to speed up customer qualification processes and audits at the Nandesari site ahead of the targeted H2 FY27 start of supplies.

Company Background

Sudeep Pharma Limited manufactures pharmaceutical excipients, food and nutrition ingredients, and specialty mineral-based solutions for customers worldwide. The company traces its roots to mineral chemistry and manufacturing expertise and emphasizes innovation, value-added products, and growth of its global presence.