Pletal (cilostazol) is a phosphodiesterase III inhibitor licensed as second-line therapy for intermittent claudication in peripheral arterial disease, contraindicated in heart failure of any severity, and available to M Care's markets as originator brand or FDA and MHRA-approved generic film-coated tablets.
M Care Exports is a merchant exporter of Pletal (cilostazol), the phosphodiesterase III inhibitor originated by Otsuka, prescribed to improve pain-free walking distance in patients with intermittent claudication who have not responded to exercise and lifestyle measures. We source FDA and MHRA-approved generic cilostazol tablets, and originator-brand supply where a tender specifies it, through licensed Indian distribution and manufacturing channels, and dispatch on quote rather than from our own manufacturing.
Cilostazol exporter and bulk supplier from India.
For hospital vascular pharmacy, wholesaler and tender-desk orders, M Care quotes cilostazol tablets against buyer specification: brand or generic, strength mix (50 mg, 100 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because cilostazol carries an absolute heart-failure contraindication and needs dose reduction with several common co-medications, we ask buyers to confirm their prescribing protocol 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.
Phosphodiesterase III (PDE3) inhibitor; antiplatelet and vasodilator, sourced and documented for export.
Cilostazol is a phosphodiesterase III (PDE3) inhibitor that raises intracellular cyclic AMP in platelets and vascular smooth muscle, giving it a dual antiplatelet and vasodilator effect distinct from statins or antiplatelet agents such as clopidogrel. Its flagship licensed indication is intermittent claudication in peripheral arterial disease, Fontaine stage II, to improve maximal and pain-free walking distance, and it is positioned as second-line therapy once supervised exercise and smoking cessation have been tried and have not sufficiently helped. It is taken orally, 100 mg twice daily as standard, 30 minutes before the morning and evening meal, with no reconstitution or injection involved. Pletal and generic cilostazol are supplied as 50 mg and 100 mg film-coated tablets, the 50 mg strength used mainly for the dose reduction required alongside certain other medicines.
Active ingredient
Cilostazol. Phosphodiesterase III (PDE3) inhibitor; antiplatelet and vasodilator.
Forms and strengths
50 mg film-coated tablet; 100 mg film-coated tablet.
Indications
Cilostazol, a phosphodiesterase III inhibitor licensed as second-line therapy for intermittent claudication in peripheral arterial disease, contraindicated in heart failure of any severity. Supplied as originator Pletal and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Film-coated 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 for cilostazol are mainly hospital vascular and cardiology outpatient pharmacies managing patients with peripheral arterial disease, national and regional MoH tender desks running cardiovascular and NCD formulary lists, licensed pharmaceutical wholesalers and importers, and vascular-surgery or stroke-prevention programmes in markets where local registration for cilostazol or its generics is in place.
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 cilostazol.
Cilostazol is dosed at 100 mg twice daily, taken 30 minutes before breakfast and the evening meal, since food raises peak plasma concentration; when a patient is co-prescribed a strong or moderate CYP3A4 or CYP2C19 inhibitor, such as omeprazole, erythromycin or azole antifungals, the dose should be halved to 50 mg twice daily, and this is a common pack-mix planning error on tender orders that specify only the 100 mg strength. Cilostazol is contraindicated in heart failure of any severity, a class effect of PDE3 inhibitors linked to reduced survival in severe heart failure trials, so this should be screened for before dispensing, alongside severe renal impairment, moderate-to-severe hepatic disease and any bleeding disorder. No cold-chain handling or reconstitution is required, cilostazol travels on standard ambient logistics. Prescribers are expected to reassess the patient at three months and discontinue therapy if walking distance has not improved, a stopping rule worth flagging on repeat-order tender specifications.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, cilostazol 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. Cilostazol does not appear on the current WHO Model List of Essential Medicines; pentoxifylline, an older and cheaper rheologic agent for the same indication, is the older alternative on many formularies, though a 2022 American Family Physician review found no significant difference between the two agents in claudication walking distance, with cilostazol causing more headache than pentoxifylline, so tender desks weighing cost against tolerability should specify which agent they intend to stock. On the brand-versus-generic question, Pletal, originated by Otsuka, remains the reference product; FDA and MHRA-approved generic cilostazol tablets from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice, and M Care confirms current registration status market by market before quoting either.
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 cilostazol.
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 cilostazol.
- 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.
Cilostazol supply, the specific questions.
Does a generic version of Pletal exist?
Yes. FDA and MHRA-approved generic cilostazol tablets are registered and marketed in the US, UK and EU alongside the Otsuka-originated Pletal brand. Registration status for generic cilostazol varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Pletal to our market?
Yes, on an import basis. We source Pletal and FDA/MHRA-approved generic cilostazol tablets through licensed Indian distribution and manufacturing channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths of cilostazol tablets are available?
50 mg and 100 mg film-coated tablets. The standard adult dose is 100 mg twice daily; the 50 mg strength is used mainly for dose reduction when a patient also takes a CYP3A4 or CYP2C19 inhibitor. Tell us your protocol and dose-reduction share and we quote the strength split accordingly.
Is cilostazol safe for patients with heart failure?
No. Cilostazol is contraindicated in heart failure of any severity, compensated or decompensated, because phosphodiesterase III inhibitors as a class have been linked to reduced survival in patients with severe heart failure. This should be screened for at initiation and flagged clearly on any dispensing record.
Why might a formulary specify cilostazol over pentoxifylline for claudication?
Both treat intermittent claudication, and a 2022 American Family Physician review found no significant difference between them in claudication walking distance, though cilostazol caused more headache than pentoxifylline. Pentoxifylline is the older alternative, so the choice on a tender often comes down to cost and tolerability rather than walking-distance outcome.
What documentation does M Care provide with a cilostazol shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration, whether the order is for Pletal or a generic cilostazol line.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.