Somazina (citicoline), also marketed as Ceraxon, is a prescription neurology medicine in Europe, the CIS, Latin America and much of Asia for stroke and traumatic brain injury recovery, though in the United States citicoline is sold only as an unregulated dietary supplement, and generic citicoline sodium lines are widely registered alongside the originator brands.
M Care Exports supplies citicoline, marketed internationally as Somazina (Ferrer) and Ceraxon (Takeda), alongside generic citicoline sodium lines, for hospital neurology and stroke-rehabilitation formularies. Citicoline is a prescription medicine across much of Europe, the CIS, Latin America and Asia, but in the United States it is sold only as an unregulated dietary supplement, not an approved drug. M Care is a merchant exporter: we source Somazina, Ceraxon and generic citicoline through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Citicoline exporter and bulk supplier from India.
For hospital pharmacy, rehabilitation-centre and tender-desk orders, M Care quotes citicoline against buyer specification: brand (Somazina or Ceraxon) or generic, tablet, oral solution or injection, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because citicoline's regulatory status shifts sharply by destination, a prescription medicine in some markets and an unregulated supplement in others, we confirm the buyer's intended registration route and labelling claims before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Cholinergic precursor / nootropic; cytidine diphosphate-choline (CDP-choline) nucleotide, sourced and documented for export.
Citicoline (cytidine diphosphate-choline, CDP-choline) is a naturally occurring nucleotide that supplies choline and cytidine for phosphatidylcholine synthesis, supporting neuronal membrane repair, and is proposed to reduce post-ischaemic glutamate release. It is not a controlled substance and is dosed orally or by injection, not requiring reconstitution. Where it is licensed as a medicine, most commonly in Spain and other European, CIS, Latin American and Asian markets under the Somazina and Ceraxon brands, the flagship use is cognitive and neurological recovery following acute ischaemic stroke and traumatic brain injury. In the United States citicoline has no FDA drug approval and is sold only as a dietary-supplement ingredient (branded forms include Cognizin) for general cognitive-support claims, not stroke treatment. Somazina is supplied as 500 mg film-coated tablets, a 100 mg/mL oral solution and a 1000 mg/4 mL solution for injection.
Active ingredient
Citicoline sodium (cytidine 5'-diphosphocholine sodium). Cholinergic precursor / nootropic; cytidine diphosphate-choline (CDP-choline) nucleotide.
Forms and strengths
500 mg film-coated tablet; 100 mg/mL oral solution; 1000 mg/4mL solution for injection.
Indications
Citicoline (CDP-choline) is a choline-donor nucleotide marketed as the prescription medicine Somazina/Ceraxon for post-stroke and traumatic brain injury recovery in much of Europe, the CIS, Latin America and Asia, and separately sold as an unregulated dietary-supplement ingredient in the United States. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral, Intramuscular, Intravenous. Film-coated tablet, oral solution and solution for injection.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for citicoline are mainly hospital neurology and stroke-unit pharmacies, rehabilitation and post-acute care centres, licensed pharmaceutical wholesalers and importers in markets where citicoline holds a medicine registration, and, where local rules permit, health-and-wellness or nutraceutical distributors sourcing citicoline as a supplement ingredient. Because citicoline is not a WHO-EML stroke medicine and sits outside most public-sector essential-medicines tenders, demand runs more through private hospital formularies, neurology specialists and licensed importers than through MoH bulk tenders.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on citicoline.
Citicoline dosing in licensed markets typically runs 500 to 2,000 mg daily, split into one or two doses, with the oral solution and film-coated tablets both used for outpatient neurology follow-up and the injection reserved for the acute inpatient phase. It carries no boxed warning and has a favourable tolerability profile, with mild gastrointestinal upset the most commonly reported adverse effect; no antidote or special monitoring protocol is required. No cold-chain handling is needed for tablets or oral solution, which travel on standard ambient logistics, though the injection should be stored as labelled and protected from light. Because citicoline's evidence base for stroke outcomes is contested, recent guideline commentary does not recommend it as standard of care, pharmacists should treat a citicoline order as a formulary-specific or clinician-directed request rather than an essential-medicines default, and should confirm with the prescriber whether the destination market's labelling supports the intended use before dispensing.
The documentation pack a regulator actually asks for.
Citicoline sits in an unusual regulatory position: it is a prescription-only medicine in Spain and a number of European, CIS, Latin American and Asian markets, but it does not have FDA marketing authorisation as a drug in the United States, where it is sold only as a dietary supplement under labelling that must avoid disease claims. Citicoline is not on the current WHO Model List of Essential Medicines, and it is not an antibiotic, so no WHO AWaRe classification applies. It is not a controlled substance in any market M Care has reviewed. Buyers should treat brand and generic as separated by destination-country registration status rather than pure interchangeability: Somazina (Ferrer) and Ceraxon (Takeda) are the recognised originator-line brands in most licensed markets, and MHRA- or EMA-equivalent generic citicoline sodium approvals should be confirmed market by market before a tender response is built, since M Care has not verified a UK MHRA licence for citicoline at the time of writing. What buyers need for registration is batch-level certificate of analysis, CDSCO export documentation and, where the destination requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside citicoline.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for citicoline.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Citicoline supply, the specific questions.
Is citicoline approved by the FDA in the United States?
No. Citicoline has no FDA drug approval in the United States and is sold there only as a dietary-supplement ingredient, marketed under names such as Cognizin, subject to supplement rather than drug regulation. In Spain and a number of European, CIS, Latin American and Asian markets, by contrast, citicoline is a licensed prescription medicine under brands including Somazina and Ceraxon. M Care confirms which regulatory pathway applies in your destination market before quoting.
What is the difference between Somazina and Ceraxon?
Both are originator-line citicoline brands built on the same active ingredient. Citicoline was originated and is marketed by Ferrer as Somazina, and Takeda separately markets citicoline as Ceraxon under its own commercialisation rights; the two brands are registered in overlapping but not identical sets of markets. M Care sources whichever brand is registered and available for your destination, or a licensed generic citicoline sodium line, against your specification.
Does a generic version of citicoline exist?
Yes, in the markets where citicoline holds a medicine registration. Generic citicoline sodium tablets, oral solution and injection are manufactured and registered alongside the Somazina and Ceraxon brands in a number of markets outside the US. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific order.
What strengths and dosage forms are available?
500 mg film-coated tablets, a 100 mg/mL oral solution and a 1000 mg/4 mL solution for injection, matching the Somazina strength range. Tell us your clinical setting, inpatient injection or outpatient oral therapy, and intended dosing, and we quote the format and strength split accordingly.
Is citicoline on the WHO Essential Medicines List?
No. Citicoline does not appear on the current WHO Model List of Essential Medicines, and recent guideline commentary does not recommend it as standard-of-care stroke therapy. Buyers typically request citicoline for a specific formulary, clinician preference or neurology-rehabilitation programme rather than as a WHO-EML first-line stroke medicine, and M Care quotes it on that basis.
Is citicoline a controlled substance, and does it need cold-chain shipping?
Citicoline is not a controlled substance in any market M Care has reviewed. Tablets and oral solution travel on standard ambient-temperature logistics; the injectable presentation should be stored and transported as labelled and protected from light, which M Care manages as a standard handling instruction rather than a validated cold-chain lane.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.