Clinical & Medical Nutrition Premix Manufacturer

Our clinical premixes cover all four FSMP categories defined under FSSAI and EU Regulation 609/2013: nutritionally complete formulae for general use, nutritionally complete formulae for disease-specific use, nutritionally incomplete formulae for disease-specific use, and formulae for infants with special medical conditions. We formulate for disease-specific applications including renal insufficiency (phosphorus and potassium management), hepatic encephalopathy, malabsorption syndromes, dysphagia, and post-surgical recovery.

Retort sterilisation (121°C, 15–20 minutes) causes significant degradation of heat-labile vitamins — particularly B1 (thiamine), B9 (folate), B12, and vitamin C. We use thermally protected encapsulation forms for heat-sensitive vitamins and set inclusion overruns calibrated to the client's specific retort cycle parameters. Post-retort analytical validation is conducted on finished product samples to confirm that label claim is met in the sterilised formula — not just in the pre-retort blend.

Yes. Our clinical premix formulations reference ESPEN (European Society for Clinical Nutrition and Metabolism) and ASPEN (American Society for Parenteral and Enteral Nutrition) guidelines for disease-specific macronutrient and micronutrient targets. Formulation rationale documents referencing the applicable guideline sections are provided with each product specification sheet — suitable for submission to hospital nutrition committees, tender authorities, and regulatory bodies requiring evidence-based substantiation.

Paediatric ONS premixes are formulated with ingredient inputs selected to meet the most stringent applicable heavy metal limits — including European Commission Regulation 2021/1369 limits for arsenic, lead, cadmium, and mercury in foods for infants and young children. Batch-level ICP-MS heavy metal testing against paediatric-specific thresholds is reported on every CoA. We can also formulate to client-specified heavy metal limits where institutional buyers have tighter internal specifications than regulatory minimums.

Yes. Renal formulae require precise restriction of phosphorus, potassium, and often sodium, while maintaining adequate vitamins and selected trace minerals — a formulation challenge that requires careful ingredient form selection to avoid hidden phosphorus contributions from carrier materials. Hepatic formulae require branched-chain amino acid (BCAA) compatible mineral profiles and often reduced copper and manganese. We formulate to disease-specific electrolyte targets agreed with the client's medical and scientific advisory team.

We prepare a full regulatory documentation package for FSSAI Foods for Special Dietary Use (FSDU) / FSMP registration — including: product categorisation opinion under FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2022; formulation specification with ingredient permissibility declarations; label claim substantiation; stability data summary; and manufacturing facility GMP and FSSAI licence documentation. We have supported FSMP registrations through the FSSAI online portal.