Sudeep Pharma Limited has received FDA approval for its new greenfield manufacturing facility located at 179 Nandesari, Gujarat. This approval authorizes the commencement of manufacturing operations, significantly boosting the company’s production capacity with an annual installed capacity of 51,200 MT. The facility will cater to growing demand in pharmaceutical, food, and nutrition sectors, with commercial supplies expected from H2 FY27.
Sudeep Pharma Secures FDA Approval for New Gujarat Facility
Sudeep Pharma Limited announced today that it has received FDA approval for its new pharma greenfield manufacturing facility situated at 179 Nandesari, Gujarat. This significant milestone grants the company authorization to commence manufacturing operations at the site, marking a crucial step in its expansion strategy.
Enhanced Manufacturing Capacity and Market Reach
The newly approved facility boasts an impressive annual installed capacity of 51,200 MT. This substantial increase in capacity is set to strengthen Sudeep Pharma’s manufacturing capabilities across its key business segments: Pharma, Food & Nutrition, and Specialty Ingredients. The approval will enable the company to meet the growing demand from both domestic and international markets more effectively. Commercial supplies from this facility are anticipated to begin in H2 FY27, following the completion of customer qualification processes.
Strategic Importance and Product Diversification
Approximately 60% of the facility’s capacity will be allocated to the company’s existing Pharma and Food & Nutrition portfolios. The remaining capacity will be dedicated to newer product categories, including phosphates, glycinates, gluconates, and citrates. The facility is also designed to accommodate high-value ingredients and new-age molecules, such as bisglycinates, which will help diversify the company’s product offerings and strengthen its presence in regulated markets.
Mr. Sujit Bhayani, Managing Director of Sudeep Pharma Limited, commented, “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.” The company aims to accelerate customer qualification processes and audits following this approval.
About Sudeep Pharma Limited
Sudeep Pharma Limited is a leading manufacturer of pharmaceutical excipients, food and nutrition ingredients, and specialty mineral-based solutions, serving customers globally. With a strong foundation in mineral chemistry and manufacturing expertise, the company is focused on innovation, value-added products, and expanding its global presence.
Source: BSE
