Contract manufacturing & private label of foods for special medical purposes
Inalme develops and manufactures foods for special medical purposes (FSMPs) under contract and in private label, for pharmaceutical and nutraceutical companies and for brands working in clinical nutrition. Our FSMPs are made in our Food Supplements Division: same production lines, same controls, same pharmaceutical forms.
We follow each project from the formula to the packaged product, in our plant in Catania, Italy, with a scientific and regulatory team that supports every step up to market launch.
- Custom formulas, developed from a clinical or nutritional need
- Production on the customer’s own formula, under a confidentiality agreement
- Flexible batch sizes, calibrated on your project volumes
- GMP manufacturing, ISO 9001 and ISO 22000 certified, FDA registered
- Products we make on sale in 36 countries
What are FSMPs
Who they are for. FSMPs are foods intended for patients who, because of a disease, disorder or particular medical condition, have nutritional requirements that cannot be met by consuming normal foods. More precisely, under EU law, they are intended for patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foods or certain nutrients or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved only by modifying the normal diet.
How they differ from food supplements. A food supplement complements the diet of healthy people: it can add vitamins, minerals, amino acids, plant extracts or other substances and can contribute to the maintenance of normal physiological functions. Food supplements are not intended to treat or manage a disease and are not a substitute for a varied and balanced diet. An FSMP, on the other hand, is intended for patients with particular nutritional requirements that cannot be met by modifying the normal diet. Because of their characteristics, FSMPs must be used under medical supervision. They are a regulatory category between food and medicine, with their own rules on composition, labelling and notification.
The rules. In the European Union, FSMPs are governed by Regulation (EU) No 609/2013 and Delegated Regulation (EU) 2016/128. When an FSMP is placed on the market, it must be notified to the competent authority of each country where it is sold; in Italy, the Ministry of Health lists notified products in the National Register of FSMPs.
Where they are sold. Pharmacies, including hospital pharmacies, and clinical nutrition channels. In some countries FSMPs can be reimbursed by the national health service. Read our article on FSMPs
Pharmaceutical forms and manufacturing plant
For FSMPs we use the same pharmaceutical forms as for food supplements, and we choose with you the one that best suits the patient, the dosage and the stability of the ingredients:
- Powders in single or paired sachets (2 to 25 g) and in jars (5 to 1,000 g)
- Tablets: swallowable, chewable, buccal, effervescent or modified-release
- Capsules and softgels, also gastro-resistant and titanium dioxide-free
- Syrups and solutions in single-dose vials (10–15 ml) or multidose bottles (100–1,000 ml)
- Drops and sprays
- Vials with DDC® cap, which keeps powder and liquid separate until consumption: useful for moisture-sensitive ingredients such as probiotics and prebiotics
We manufacture in our plant in Catania: about 6,000 m², two production areas and laboratories for research and development and quality control. Capacity of up to 630,000 tablets, 280,000 capsules and 42,000 DDC® single doses per day.
Our certifications
How we work, from idea to finished product
Every project follows ten steps, in this order.
- Identification of the formula: together with you, we define the formula based on the medical condition it is intended for and on market requirements.
- Design: we combine research, formulation, safety, regulatory compliance and efficacy.
- Regulatory compliance: we check compliance with FSMP rules and prepare the documentation for market placement.
- Prototyping and industrial scale-up: with analyses and tests we take the product from pilot scale to large-scale production.
- Finished product analysis and testing: physico-chemical, microbiological and heavy metal tests, and claim verification.
- Graphics and packaging: we design label and pack with your brand.
- Manufacturing: state-of-the-art machinery and GMP processes.
- Quality control: checks throughout the whole manufacturing process.
- Placing on the market: our Production, Quality and Regulatory Affairs teams work together for a compliant launch.
- Logistics: procurement, storage and distribution, with on-time delivery.
Beyond the formula, one partner
Whatever collaboration model you choose, we also support you in everything that comes after the formula:
- Raw materials: sourcing of certified raw materials
- Regulatory: label texts and documentation for market placement
- Graphics and packaging: box and label designed by our design team
- Testing: physico-chemical, microbiological and heavy metal analyses, gluten and lactose testing
- Logistics: procurement, storage and distribution
Frequently asked questions
Do you have an FSMP to develop?
Tell us about your project: the medical condition it is intended for, the formula if you already have one, or just the idea. We will reply with a first assessment of formula, pharmaceutical form and packaging.
Your request goes directly to our export manager, who replies within 48 working hours.
