Aripiprazole is a partial dopamine D2/D3 and serotonin 5-HT1A agonist rather than a full receptor blocker, the only third-generation antipsychotic M Care stocks, and that mechanism is what a tender committee is actually comparing when asked to substitute it for risperidone or olanzapine.
Most antipsychotics work by blocking dopamine outright. Aripiprazole partially activates the same D2 and D3 receptors instead, a mechanism that gives it a different side-effect signature and was the specific reason US regulators issued a 2016 safety communication on compulsive gambling, shopping, eating and sexual behaviour. M Care Exports supplies aripiprazole oral tablets across 35 catalogue lines and seven strengths, sourced from WHO-GMP certified Indian manufacturers, to regulatory affairs teams, hospital procurement desks and licensed importers outside India.
Aripiprazole exporter and bulk supplier from India.
Export consignments are documented with a Certificate of Analysis, Certificate of Pharmaceutical Product, and manufacturer's WHO-GMP certificate for each of the 35 lines carried, since strength and brand vary by line and importing regulators generally require product-specific paperwork rather than a molecule-level dossier. Aripiprazole tablets are packed in standard blister strips inside cartons, matching normal solid-oral handling with no cold chain requirement. Because aripiprazole spans adult and pediatric dosing on the same tablet strengths (2mg through 30mg), buyers building a mixed shipment for both adult psychiatric and pediatric irritability or Tourette's indications should confirm which strengths their import registration actually covers before order confirmation, since not every strength is registered in every market. CDSCO export documentation accompanies every shipment.
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.
Third-generation (atypical) antipsychotic; partial agonist at dopamine D2/D3 and serotonin 5-HT1A receptors, antagonist at serotonin 5-HT2A receptors, sourced and documented for export.
Aripiprazole belongs to the third generation of antipsychotics because it partially activates dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, rather than blocking them outright the way older and most second-generation agents do. That partial agonism is the reason the US FDA issued a 2016 safety communication naming aripiprazole specifically for compulsive gambling, shopping, binge eating and hypersexual behaviour, a signal not raised for full-antagonist antipsychotics. Clinically it is used across schizophrenia, bipolar I disorder, adjunctive treatment of major depressive disorder, and, in pediatric populations, irritability associated with autistic disorder and Tourette's disorder. It carries the same class boxed warning on mortality in elderly dementia-related psychosis as other antipsychotics, plus a suicidality warning tied to its antidepressant-adjunct use in younger patients. M Care's tablet range, 2mg to 30mg, spans the full adult and pediatric titration schedule.
Active ingredient
Aripiprazole. Third-generation (atypical) antipsychotic; partial agonist at dopamine D2/D3 and serotonin 5-HT1A receptors, antagonist at serotonin 5-HT2A receptors.
Forms and strengths
2 mg; 2.5 mg; 5 mg; 10 mg; 15 mg; 20 mg; 30 mg.
Indications
Aripiprazole is an oral antipsychotic used in schizophrenia, bipolar I disorder, adjunctive treatment of major depressive disorder, and, in pediatric populations, irritability associated with autistic disorder and Tourette's disorder. M Care Exports supplies aripiprazole oral tablets sourced from WHO-GMP certified Indian manufacturers across 35 catalogue lines.
Administration
Oral. Tablet.
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 are regulatory affairs teams and procurement desks at hospitals, psychiatric units and licensed distributors across the UK, the EU, Gulf and GCC markets, Africa, Latin America, Southeast Asia and the CIS, sourcing aripiprazole for national formularies and tender supply where a third-generation antipsychotic with a distinct metabolic and prolactin profile is specified. Mental health tender desks often stock aripiprazole alongside older agents rather than in place of them, since patients are switched based on individual response and tolerability, so orders tend to specify particular strengths for titration rather than a single dominant SKU. India is the country of origin only; M Care does not supply into the Indian domestic market.
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 aripiprazole.
A reviewing pharmacist should confirm that the product information for each line correctly frames aripiprazole's mechanism (partial agonism at dopamine D2/D3 and serotonin 5-HT1A receptors, antagonism at 5-HT2A) rather than describing it as a straightforward dopamine antagonist, since this affects how the impulse-control-disorder warning and the comparatively lower prolactin-elevation and metabolic-syndrome signal relative to full-antagonist agents are communicated downstream. The FDA's 2016 safety communication on compulsive gambling, shopping, eating and sexual behaviour should be checked against the local product literature and patient information leaflet for each importing market, since disclosure requirements vary. Interaction review should flag CYP2D6 and CYP3A4 involvement in aripiprazole metabolism, relevant for co-prescribed CYP inhibitors or inducers in polypharmacy psychiatric regimens. The boxed warning on increased mortality in elderly dementia-related psychosis and the suicidality warning tied to adjunctive major depressive disorder use should both appear unmodified in any repackaged or relabelled literature. Batch-specific impurity and dissolution data should be reviewed per line rather than assumed consistent across the catalogue's 35 SKUs.
The documentation pack a regulator actually asks for.
Each of the 35 aripiprazole lines ships with a Certificate of Analysis and Certificate of Pharmaceutical Product from the originating WHO-GMP certified Indian manufacturer, plus the manufacturer's own GMP certificate, since M Care does not manufacture and holds no GMP or WHO-PQ certification of its own. M Care's export documentation is built on its ISO 9001:2015 quality management certification and CDSCO export licence, which cover the export and quality-management process, not the manufacturing standard of the product itself; that distinction should be stated plainly in any tender submission. Because aripiprazole carries a molecule-specific FDA safety communication (impulse-control disorders) in addition to the class boxed warning on antipsychotic mortality risk in dementia-related psychosis, importers registering the product in a new market should confirm their national regulator's current labelling requirements for both, rather than relying on a generic antipsychotic dossier template. Stability data, dissolution profiles and any local bioequivalence requirement remain line-specific and should be requested per brand and strength rather than assumed uniform across the range.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Boxed warning: increased mortality in elderly patients with dementia-related psychosis; aripiprazole is not approved for this use.
Boxed warning: increased risk of suicidal thinking and behaviour in children, adolescents and young adults, relevant to adjunctive antidepressant use.
FDA Drug Safety Communication (May 3, 2016): risk of compulsive or uncontrollable urges including gambling, shopping, eating and sexual behaviour, linked to aripiprazole's partial dopamine agonist mechanism.
Prescription-only medicine; not for patient self-selection or over-the-counter sale.
M Care holds no WHO-GMP or WHO-PQ certification; M Care's own credentials are ISO 9001:2015 and a CDSCO export licence only.
India is not a served market; M Care supplies export markets outside India only.
Adjacent lines procurement desks order alongside aripiprazole.
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 aripiprazole.
- 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.
Aripiprazole supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and holds neither WHO-GMP nor WHO-PQ certification itself. M Care's own credentials are ISO 9001:2015 quality management certification and a CDSCO export licence. Every aripiprazole line is sourced from Indian manufacturers that hold WHO-GMP certification directly, and manufacturer GMP certificates are provided with each shipment.
What is the main safety signal regulatory teams should know about aripiprazole specifically?
Beyond the class boxed warning on antipsychotic mortality risk in elderly dementia-related psychosis, the FDA issued a 2016 safety communication naming aripiprazole specifically for compulsive gambling, shopping, binge eating and hypersexual behaviour, linked to its partial dopamine agonist mechanism. This is a molecule-specific signal, not raised for full dopamine-antagonist antipsychotics, and should be reflected in local labelling and pharmacovigilance agreements.
Which dosage forms of aripiprazole does M Care supply?
M Care's 35 aripiprazole lines are all oral tablets, in strengths from 2mg to 30mg. M Care does not currently stock aripiprazole capsules, injectable formulations, oral suspension, or any other dosage form; buyers requiring those forms should confirm availability separately, as this catalogue covers tablets only.
How does aripiprazole's mechanism differ from other antipsychotics in a tender comparison?
Aripiprazole is a partial agonist at dopamine D2/D3 and serotonin 5-HT1A receptors and an antagonist at serotonin 5-HT2A receptors, rather than a full dopamine antagonist. This is generally associated with a lower prolactin-elevation and metabolic-syndrome burden than some full-antagonist agents, though individual patient response varies and tender desks should not treat this as a blanket clinical equivalence claim.
What documentation accompanies each aripiprazole shipment?
Each line ships with a Certificate of Analysis, Certificate of Pharmaceutical Product, and the originating manufacturer's WHO-GMP certificate, alongside M Care's own ISO 9001:2015 certification and CDSCO export licence. Because strength and brand vary across the 35 lines, documentation is issued per line rather than as a single molecule-level dossier.
Can aripiprazole tablets cover both adult and pediatric prescribing needs?
The catalogue's strength range, 2mg through 30mg, spans dosing used in adult schizophrenia and bipolar indications as well as pediatric irritability associated with autistic disorder and Tourette's disorder, where titration typically starts at 2mg. Buyers should confirm which specific strengths are registered for pediatric use in their importing market before ordering.
Does M Care supply into the Indian domestic market?
No. India is M Care's country of origin only. M Care supplies aripiprazole exclusively to buyers outside India, including regulatory affairs teams, hospital procurement and licensed importers across the UK, EU, Gulf and GCC, Africa, Latin America, Southeast Asia and the CIS.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.