Bespoke choline, citicoline and alpha-GPC supplement manufacturing

Choline salts, citicoline and alpha-GPC for each market's rules

In our Leicester facility, custom choline, citicoline and alpha-GPC supplements, and phosphatidylserine formulas, go from the first formula to the finished pack for premium wellness brands, made by us as a citicoline manufacturer: capsules, tablets, powders, stick packs, gummies, shots and functional pouches. We choose the choline form for each market and set a dose that meets the claim conditions, with citicoline at up to 500 mg a day for the UK and EU. You receive evidence you can show a buyer: choline calculations from the exact grade, certificates of analysis and a stability summary. Choline sits within our nootropic and brain health supplement manufacturing, beside L-theanine and functional mushrooms.

EFSA set an adequate intake of choline of 400 mg a day for adults, 480 mg in pregnancy and 520 mg in lactation (EFSA, 2016), while in the US, supplements typically provide 10 to 250 mg of choline and prenatal supplements typically contain little if any (NIH Office of Dietary Supplements, 2022). Each form delivers a different share of choline, behaves differently in production and has its own legal status. We calculate choline content from each compound's formula and IUPAC atomic weights, and every label value from the exact grade on the certificate of analysis.

Phosphatidylserine

Phosphatidylserine carries serine, not choline, on its phospholipid head, and its source matters. Early trials used bovine brain material; today's grades come from lecithin, and the soya grade is made by enzymatic transphosphatidylation of soy lecithin with L-serine. EFSA found no cause and effect between phosphatidylserine and memory in older people, and noted that bovine and soy phosphatidylserine are different substances, so results from one cannot be transferred to the other (EFSA, 2010).

From 82.5 mg of choline to 500 mg of citicoline

The 82.5 mg claim floor and the 500 mg cap

The claim condition sets the floor: 82.5 mg of choline per portion takes about 200 mg of choline bitartrate. Citicoline adds human data: in a randomised, double-blind trial in 100 healthy adults aged 50 to 85, 500 mg a day for about three months improved episodic memory scores against placebo (Nakazaki and colleagues, Journal of Nutrition, 2021). The ingredient's maker funded it. Citicoline is capped at 500 mg a day in UK and EU food supplements, the dose used in that trial. For US alpha-GPC products, 203.7 mg supplies the same 82.5 mg of choline. At the top end, the US upper level for choline is 3.5 g a day for adults, and gut bacteria convert some choline to trimethylamine, the compound behind choline's fishy note (NIH Office of Dietary Supplements, 2022), so a high-dose formula needs a clear reason.

Plasma choline curves by form

Form changes the curve more than the total. In a randomised crossover study in six healthy men, equal doses of 550 mg of choline from choline chloride, choline bitartrate, alpha-GPC and egg phosphatidylcholine produced similar total plasma choline. The bitartrate rose fastest, with peaks at about one to two hours, and egg phosphatidylcholine peaked latest, at about three hours. All the water-soluble forms raised plasma TMAO, a metabolite of trimethylamine, while egg phosphatidylcholine did not (Böckmann and colleagues, European Journal of Nutrition, 2022). Citicoline splits into choline and cytidine, and in people oral doses raise blood choline and uridine, the form cytidine takes in humans (Wurtman and colleagues, Biochemical Pharmacology, 2000).

Alpha-GPC, choline chloride and moisture

Water is the main enemy. Alpha-GPC is highly hygroscopic, turns gel-like as it absorbs moisture and smells faintly of fish, and choline chloride also pulls water from the air. We weigh and blend these forms within the humidity limits set for the product, and fill them into HPMC capsules, whose shells hold 4% to 6% moisture against 13% to 16% for gelatine, so a hygroscopic fill has less water to draw from the shell (Al-Tabakha, 2010). Packs carry a desiccant and a high moisture barrier. Phospholipids oxidise, so phosphatidylcholine and phosphatidylserine need antioxidant protection and nitrogen-flushed packs.

B vitamin partners and no known medicine interactions

Choline is not known to have any clinically relevant interactions with medicines (NIH Office of Dietary Supplements, 2022). Within a formula, it works with folate, vitamin B6 and vitamin B12 in one-carbon metabolism, and each of the four carries an authorised claim for normal homocysteine metabolism, so they sit well together. For a cognitive message in the UK and EU, the claim comes from nutrients such as zinc, iron and iodine, which "contribute to normal cognitive function".

Citicoline in the UK and EU, alpha-GPC only in the US

Three choline claims and a citicoline cap in GB and the EU

As of October 2026, choline carries three authorised claims on the GB nutrition and health claims register and the EU register: "Choline contributes to normal homocysteine metabolism", "Choline contributes to normal lipid metabolism" and "Choline contributes to the maintenance of normal liver function", each for food with at least 82.5 mg of choline per 100 g or 100 ml or per single portion. Citicoline, alpha-GPC and phosphatidylserine carry none.

Citicoline can be used in UK and EU food supplements at up to 500 mg a day under its novel food authorisation, named "citicoline" on the label, with a statement that the product is not intended for children. Soy phosphatidylserine can be used in food supplements in both markets, and a soy product with equal amounts of phosphatidylserine and phosphatidic acid is authorised at up to 800 mg of phosphatidylserine a day, not for marketing to pregnant or breastfeeding women. Alpha-GPC is not authorised in the UK or EU, so we make alpha-GPC products for the US and use citicoline or choline salts for UK and EU formulas. Our regulation watch tracks every change that affects your product.

Alpha-GPC, choline Daily Value and a qualified claim in the US

As of October 2026, choline salts, citicoline and alpha-GPC sell as dietary ingredients, and Supplement Facts declare choline against a Daily Value of 550 mg. FDA has also raised no questions on a GRAS notice for alpha-GPC as a source of choline in foods and drinks. Structure and function claims, such as "supports memory", carry FDA's disclaimer, are notified to FDA and need competent and reliable scientific evidence. Phosphatidylserine has a qualified health claim that must use FDA's own wording, including its statement that the evidence is very limited. We are an FDA registered food facility for dietary supplements.

Choline calculations in the document file

For each market we prepare the label text, the claims wording and the document file buyers and marketplaces ask for: the finished product specification, certificates of analysis, choline calculations from the exact grade, a stability summary and allergen statements, with soy and egg sources declared.

Capsules for alpha-GPC, shots and pouches for citicoline

• Capsules and tablets: the main format for citicoline, alpha-GPC and phosphatidylserine; see capsule and tablet manufacturing.
• Powders, sachets and stick packs: choline bitartrate and citicoline dissolve readily in drink mixes; see powder supplement manufacturing.
• Gummies: citicoline and choline bitartrate at modest doses, with tart and bitter notes masked.
• Liquids and shots: citicoline and choline salts dissolve fully. Citicoline is cleared for food supplements only in the UK and EU, so citicoline drinks there are made as supplements in dose form, such as shots.
• Functional pouches: citicoline within its authorisation, alone or with L-theanine; see nootropic, caffeine and energy pouches.

Development runs in stages. We calculate the choline delivered by each candidate grade, make bench samples to fix taste, fill weight and pack, then run a pilot batch whose assay, moisture and stability results set the final specification and label values.

Every format is made in our Leicester facility, which is ISO 9001, HACCP and GMP certified by BSI, and FDA registered, and our capsules, gummies, pouches and liquids are GMP certified within our BSI scope. Your formula is yours: the specification, doses and data belong to your brand, as our formula ownership commitment sets out.

Screening each choline form for novel food status

1. Screen and specify. We screen every form in-house against the novel food rules of each target market, then agree form, grade, choline target, label tolerance and pack with you.
2. Approve and receive. Supplier approval comes before any material is used, with a review every year. Each lot arrives with a certificate of analysis, and hygroscopic forms arrive sealed.
3. Weigh and blend. Materials are weighed against the batch record within the humidity limits set for the product, under our allergen management plan with yellow colour coding; soy and egg sources are declared as allergens.
4. Fill or form. Capsules are filled and checked by weight, powders filled into tubs, sachets or stick packs, gummies cooked and deposited, and pouches dosed and sealed.
5. Pack. Each product goes into the pack its stability study approved: high-barrier bottles with desiccant for hygroscopic forms, foil stick packs for powders and nitrogen-flushed packs for phospholipids, coded with batch number and best-before date.
6. Label and release. Label verification on every batch is the critical control point in our HACCP plan, CCP-01, and it covers the citicoline name and statement. Three retained samples per batch are kept for shelf life plus one year, and nothing is dispatched without quality control sign-off.

A citicoline manufacturer assays each choline form its own way

Ask how each form is identified and how its choline is proved. Every batch is tested by accredited partner laboratories (ISO/IEC 17025) as part of every order, and your specification sets the release tests:

• Assay: citicoline by HPLC; choline by ion chromatography; alpha-GPC by HPLC with a universal detector, because it absorbs little UV light; phosphatidylserine by HPLC or phosphorus NMR. Gummies get an active assay on every batch as standard.
• Identity and purity: the form and grade confirmed against the specification, with related substances and, for choline salts, trimethylamine.
• Moisture and microbiology: water content and water activity for hygroscopic forms, with total viable count, yeasts and moulds.
• Heavy metals and stability: lead, cadmium, mercury and arsenic, and accelerated and real-time stability studies on every new formula, tracking assay, odour and appearance.

Our quality system adds a HACCP study per product type, reviewed annually, and a full mock recall, forward and backward with mass balance, in seconds; our testing and batch release page sets out the full approach. Research and development is a paid stage that can be included with an order of the right size. Start your project with your target markets, and we will propose the form, the dose and the claims route.

References: EFSA, Dietary Reference Values for choline (2016); NIH Office of Dietary Supplements, choline fact sheet (2022); Commission Regulation (EU) No 432/2012 (2012); Commission Implementing Decision 2014/423/EU (2014); EFSA, phosphatidylserine health claims opinion (2010); Wurtman and colleagues, Biochemical Pharmacology (2000); Nakazaki and colleagues, Journal of Nutrition (2021); Böckmann and colleagues, European Journal of Nutrition (2022).