Stemetil (prochlorperazine), also marketed as the buccal formulation Buccastem, is licensed for nausea, vomiting and vertigo, and for short-term adjunctive use in anxiety and psychotic disorders, with FDA and MHRA-approved generic prochlorperazine tablets and injection available alongside the originator brand.
Stemetil (prochlorperazine), marketed in the UK by Atnahs Pharma, is a phenothiazine antiemetic and antipsychotic used for nausea, vomiting, vertigo and, buccally as Buccastem, migraine-associated sickness. M Care Exports is a merchant exporter: we source FDA and MHRA-approved generic prochlorperazine tablets, buccal tablets and injection through licensed Indian manufacturing channels and dispatch on quote, not from our own manufacturing.
Also marketed as Compazine, Procomp and Compro.
Prochlorperazine exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes prochlorperazine against buyer specification: dosage form (oral tablet, buccal tablet or intramuscular injection), strength mix and destination-market regulatory documentation, drawn from licensed Indian manufacturer lines. Because prochlorperazine's anxiety-adjunct dosing is capped by FDA labelling at 20 mg per day for no more than twelve weeks, while UK SmPC labelling permits up to 40 mg daily in divided doses under the same tardive-dyskinesia caution, we confirm the buyer's intended indication and destination market 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.
Phenothiazine antiemetic and first-generation antipsychotic; dopamine D2-receptor antagonist, sourced and documented for export.
Prochlorperazine is a phenothiazine, a dopamine D2-receptor antagonist that blocks the chemoreceptor trigger zone to control nausea and vomiting, and at higher doses acts as a first-generation antipsychotic. It is dosed orally, buccally or by deep intramuscular injection, and needs no reconstitution or cold-chain handling. UK SmPC labelling covers nausea and vomiting of any cause including migraine, vertigo from Meniere's syndrome and labyrinthitis, schizophrenia and acute mania, and short-term adjunctive treatment of anxiety; US labelling covers the same nausea/vomiting and psychotic-disorder indications, and specifically caps the anxiety-adjunct dose at 20 mg per day for no more than twelve weeks, whereas the UK SmPC permits up to 40 mg daily under the same tardive-dyskinesia caution. Stemetil is supplied as 5 mg tablets, Buccastem as 3 mg buccal tablets that dissolve against the upper gum, and Stemetil injection as a 12.5 mg/1 ml intramuscular solution; generic prochlorperazine tablets and injection are separately marketed in the US, UK and EU.
Active ingredient
Prochlorperazine maleate (tablets); prochlorperazine mesilate (injection). Phenothiazine antiemetic and first-generation antipsychotic; dopamine D2-receptor antagonist.
Forms and strengths
5 mg film-coated tablet; 3 mg buccal tablet; 12.5 mg/1ml solution for injection.
Indications
Prochlorperazine, a phenothiazine dopamine D2-receptor antagonist indicated for nausea, vomiting, vertigo and, at higher doses, schizophrenia and acute mania, with short-term adjunctive use in anxiety. Supplied as originator Stemetil/Buccastem and licensed generic tablets, buccal tablets and injection from Indian manufacturing channels to regulated and semi-regulated markets outside India.
Administration
Oral, Buccal, Intramuscular. Film-coated tablet, buccal tablet, 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 prochlorperazine are mainly hospital and emergency-department pharmacies stocking an antiemetic for postoperative and migraine-related nausea, neurology and headache clinics using the buccal or injectable form, national and regional MoH tender desks running general-hospital formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting basic emergency and surgical-care formularies where a low-cost antiemetic and adjunctive antipsychotic is needed.
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 prochlorperazine.
Prochlorperazine dosing splits by route and indication: 5-10 mg oral tablets two to three times daily for nausea prevention, a single 20 mg dose followed by 10 mg after two hours for acute treatment, up to 30 mg daily in divided doses for vertigo, and 12.5 mg by deep intramuscular injection when the oral or buccal route is not tolerated, with oral treatment resumed around six hours later. Buccastem's 3 mg buccal tablet is placed high against the upper gum, not swallowed or chewed, and is licensed only for migraine-associated nausea in adults for a maximum of two days. Elderly patients need lower starting doses because of increased postural-hypotension and extrapyramidal-symptom susceptibility. As an anxiety adjunct, FDA labelling caps the dose at 20 mg daily for no more than twelve weeks to limit irreversible tardive dyskinesia risk, while UK SmPC labelling permits up to 40 mg daily in divided doses under the same caution. Prochlorperazine carries a boxed warning: elderly patients with dementia-related psychosis treated with antipsychotics, prochlorperazine included, face an increased risk of death, and it is not approved for that use. No cold-chain handling or reconstitution is required at any dose form.
The documentation pack a regulator actually asks for.
As an oral, buccal and injectable small molecule, prochlorperazine travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Prochlorperazine does not currently appear on the WHO Model List of Essential Medicines; the WHO's antiemetic entries are built around metoclopramide, ondansetron and dexamethasone, so tender desks that specify prochlorperazine are typically doing so for formulary continuity or the buccal-migraine niche rather than an EML mandate. On the brand-versus-generic question, Stemetil (tablets and injection, Atnahs Pharma UK) and Buccastem (buccal tablets, Alliance Pharmaceuticals) remain the UK originator products; FDA and MHRA-approved generic prochlorperazine tablets and injection from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice, and prochlorperazine is not a scheduled or controlled substance in any of these markets.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 prochlorperazine.
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 prochlorperazine.
- 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.
Prochlorperazine supply, the specific questions.
Does a generic version of Stemetil or Buccastem exist?
Yes. FDA and MHRA-approved generic prochlorperazine tablets and injection are registered and marketed in the US, UK and EU alongside the originator brands Stemetil and Buccastem. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Stemetil or Buccastem to our market?
We can source both the originator brand and its licensed generic equivalent for Stemetil and Buccastem, subject to availability, and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What dosage forms and strengths of prochlorperazine are available?
5 mg oral tablets, 3 mg buccal tablets (Buccastem-equivalent), and a 12.5 mg/1 ml intramuscular injection, matching the originator strengths. Tell us your indication, route and dosing protocol and we quote the format mix accordingly.
Is prochlorperazine on the WHO Essential Medicines List?
No. Prochlorperazine does not currently appear on the WHO Model List of Essential Medicines; the WHO's antiemetic entries are built around metoclopramide, ondansetron and dexamethasone. Tender desks that specify prochlorperazine are typically doing so for existing formulary continuity or its buccal-migraine niche rather than an EML mandate.
Is prochlorperazine a controlled substance?
No. Prochlorperazine is not scheduled or controlled in the US, UK or EU. It does, however, carry a boxed warning for elderly patients with dementia-related psychosis, who face an increased risk of death on antipsychotic treatment, an indication for which prochlorperazine is not approved.
How is prochlorperazine dosed for anxiety versus nausea?
For nausea and vomiting, typical adult dosing is 5-10 mg orally two to three times daily, or 12.5 mg by intramuscular injection when oral treatment is not tolerated. As an anxiety adjunct, FDA labelling caps the dose at 20 mg per day for no more than twelve weeks, because higher or longer-duration dosing raises the risk of persistent, potentially irreversible tardive dyskinesia; UK SmPC labelling permits a higher range, up to 40 mg daily in divided doses, under the same caution.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
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.