Sudeep Pharma Receives FDA Approval for Gujarat Plant

FDA approval for Nandesari facility

Sudeep Pharma has received FDA approval for a new greenfield facility in Nandesari, Gujarat, according to Scanx. The facility has installed annual capacity of 51,200 MT.

Scanx described the approval as applying to the new Nandesari site. The reported capacity allocation spans Sudeep Pharma’s existing pharma and food portfolios, alongside newer product areas.

Capacity allocation across portfolios

About 60% of the facility’s capacity is allocated to Sudeep Pharma’s existing pharma and food portfolios, Scanx reported. The remaining capacity is intended for newer products, including phosphates and bisglycines.

The allocation identifies both established portfolio activity and products named by Scanx as newer areas for the plant. The report does not provide further detail on individual product volumes within the 51,200 MT installed annual capacity.

• New greenfield facility in Nandesari, Gujarat.
• FDA approval reported by Scanx.
• Installed annual capacity of 51,200 MT.
• About 60% of capacity allocated to existing pharma and food portfolios.
• Remaining capacity for newer products including phosphates and bisglycines.

Commercial supply timing

Commercial supplies from the Nandesari facility are expected to begin in H2 FY27, according to Scanx. The reported timing follows the FDA approval and the stated allocation of capacity between existing portfolios and newer products.

For medical and pharmaceutical sales professionals, the announcement concerns an FDA-approved manufacturing facility and the company’s reported plans for commercial supplies. Scanx’s report specifically identifies phosphates and bisglycines among the newer products intended for the remaining capacity.

The announcement centers on the Nandesari, Gujarat facility, its 51,200 MT installed annual capacity, and its planned commercial-supply start in H2 FY27.