Clopidogrel tablet — Indian WHO-GMP supply for the NICE TA210 ACS pathway, NICE TA213 stroke pathway and global cardiovascular tender lines.
Thienopyridine P2Y12 antiplatelet, the standard partner for aspirin in dual antiplatelet therapy after ACS and PCI, and a stroke and PAD secondary-prevention agent in its own right. 75mg maintenance and 300mg loading-dose film-coated tablets from Indian WHO-GMP facilities. Multiple partner lines under WHO Prequalification for Global Fund and donor procurement. CYP2C19 pharmacogenomic-aware documentation pack, PPI-interaction prescribing notes, and the post-2009 FDA / EMA bleeding-risk SmPC verbatim in destination-language PIL.
Multiple WHO-GMP partner lines · 75mg maintenance and 300mg loading-dose film-coated tablets · CTD dossier on file · NICE TA210 ACS / TA213 stroke pathway · WHO EML core list.
Active ingredient
Clopidogrel bisulfate film-coated tablets. Mechanism: clopidogrel is a thienopyridine prodrug requiring hepatic two-step bioactivation, primarily by CYP2C19, to its active thiol metabolite. The active metabolite covalently and irreversibly binds the P2Y12 ADP receptor on platelets for the platelet's 7-10 day lifespan, blunting ADP-induced platelet aggregation and GpIIb/IIIa activation. Maximum antiplatelet effect at 5-7 days on 75mg daily, or within 6 hours on a 300mg loading dose.
Strengths stocked
75mg film-coated tablet — standard daily maintenance dose for all approved indications. 300mg film-coated tablet — loading dose for ACS and PCI; some centres use 600mg (four 75mg or two 300mg) but the SmPC reference loading dose is 300mg. Tablets are commonly pink, round or oblong, film-coated, supplied in 28 / 30 / 90 tablet HDPE bottles or destination-language blister packaging. Hospital-pack 28-count blisters for NHS ACS protocols available on request.
Indications scope
Acute coronary syndrome (STEMI, NSTEMI, unstable angina) per NICE TA210 with 12-month DAPT; post-PCI DAPT with aspirin for 6-12 months; secondary stroke and TIA prevention per NICE TA213 (CAPRIE evidence); peripheral arterial disease; stable CAD in aspirin-intolerant patients; atrial fibrillation second-line where anticoagulation contraindicated; selected CABG graft-patency protocols. Ticagrelor (NICE TA236) and prasugrel (NICE TA317) are first-line in some ACS pathways, but clopidogrel remains the dominant DAPT partner globally on bleeding-risk and cost grounds.
Buyer fit
UK NHS hospital and community pharmacy at Drug Tariff Category M generic dispensing scale — high-volume ACS, post-PCI and stroke secondary-prevention line. GCC ACS and cardiology tender desks: Saudi Arabia (NUPCO, SFDA-registered), UAE (MoHAP, DHA, JCI-accredited cardiac centres), Kuwait (CMSPS), Qatar (Hamad Medical Corporation), Oman (MoH, OFDA), Bahrain (NHRA). African public-sector procurement: NAFDAC (Nigeria), KEMSA (Kenya), CMS (Ghana), SAHPRA (South Africa), EFDA (Ethiopia). Global Fund and donor procurement: cardiovascular comorbidity programmes in HIV / NCD bundled tenders.
What we file with the quote
Indian manufacturer's CDSCO Form 26 export licence and EU-GMP / WHO-GMP certificate, Certificate of Pharmaceutical Product (CoPP) per WHO format for the destination regulator, batch Certificate of Analysis (CoA) against the manufacturer's BP/USP/EP-aligned monograph including impurity profile (clopidogrel has historically had related-substance specifications under tight ICH Q3A control), dissolution profile for clopidogrel-bisulfate finished dosage, SmPC and PIL per destination regulator's format with CYP2C19 / PPI / bleeding-risk warnings verbatim, full CTD Module 1-5 dossier for new-market registration, and NHS Drug Tariff line confirmation for UK community-pharmacy buyers.
Lead times
Stock items 75mg ship in 10-14 working days from PO ex-Mumbai. 300mg loading-dose strength typically 14-21 working days due to lower campaign frequency. Tender quantities (>1M tablets per dose-strength) require campaign batch scheduling; lead time 4-6 weeks from PO. Named-patient and small-volume orders for hospital pharmacy ship in 5-7 working days from existing campaign stock. Cold-chain not required — ambient transport with desiccant for tropical destinations.
Four buyer-channel models for an Indian-manufactured clopidogrel export.
Clopidogrel is one of the highest-volume cardiovascular tender lines globally. NHS hospital ACS protocols, GCC cardiology centre formularies, African public-sector cardiovascular tenders and donor-funded cardiovascular comorbidity programmes are the four dominant buyer channels — each with different paperwork tracks.
UK NHS hospital and community pharmacy
NICE TA210 (ACS) and NICE TA213 (stroke secondary prevention) are the two reference technology appraisals driving NHS clopidogrel volume. M Care supplies UK WDA(H)-licensed wholesalers against NHS framework agreements, with QP audit pack on file for EU/UK GMP equivalence, batch-by-batch Certificate of Analysis (CoA) in BP-aligned format including the related-substances impurity profile, and Article 40 / EU-IMPD release pathway through partner UK MIA(IMP) holders for non-EEA imports post-Brexit. Hospital pack 28-count blisters for ACS DAPT initiation packs supplied to acute trusts on request. Pricing follows Cat M reimbursement bands.
GCC ACS and cardiology tender supply
Gulf Health Council Central Registration route or state-by-state via SFDA (KSA), MoHAP (UAE), CMSPS (Kuwait), MoPH (Qatar), MoH/OFDA (Oman), NHRA (Bahrain). Clopidogrel is on every GCC state's essential medicines list. Saudi NUPCO framework responses for the large cardiac-centre tenders (King Faisal, King Saud) where clopidogrel is the high-volume ACS DAPT partner. UAE JCI-accredited cardiac centres with hospital-pack DAPT initiation packs. Arabic SmPC + PIL translations on file with CYP2C19 and PPI-interaction warnings; three Indian partner manufacturers with active SFDA registrations for supply redundancy.
African public-sector cardiovascular procurement
NAFDAC (Nigeria), PPB (Kenya), FDA (Ghana), SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania) registration pathways. WHO Prequalification active for several Indian clopidogrel generic lines, opening Global Fund HIV-CVD comorbidity, PEPFAR NCD comorbidity, and World Bank-funded cardiovascular programme procurement. Sea-freight LCL/FCL via Mumbai/Nhava Sheva to Lagos / Mombasa / Durban / Dar es Salaam; 6-8 week sea transit. No cold-chain. Antiplatelet-anticoagulant differentiation documentation supplied to MoH pharmacy committees on request — clopidogrel is not interchangeable with warfarin or DOACs and the formulary differentiation matters.
EU and other regulated markets
EU member states via Article 40 importation licence held by partner MIA(IMP) and QP batch certification; LATAM via ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), DIGEMID (Peru); SEA via Philippines FDA, Vietnam DAV, Indonesia BPOM, Malaysia NPRA, Bangladesh DGDA. Clopidogrel is registered in 100+ countries via Indian generic manufacturers; M Care's role is dossier and tender-pack assembly, not standalone manufacturing. Aspirin + clopidogrel FDC combinations are supplied on a separate workflow with FDC partner manufacturer cadence.
CYP2C19 polymorphisms, PPI co-prescription, ticagrelor switching, bleeding screen — clopidogrel is everyday but the prescribing nuances matter.
Adult ACS dose is 300mg loading dose (some protocols 600mg in primary PCI) followed by 75mg once daily for 12 months in DAPT with aspirin. Stable post-PCI DAPT 6-12 months depending on stent type and bleeding risk. Stroke secondary prevention 75mg daily monotherapy per NICE TA213. No routine renal or hepatic dose adjustment, but caution in severe renal impairment and in moderate-severe hepatic impairment. CYP2C19 pharmacogenomics is the major prescribing nuance: clopidogrel is a prodrug bioactivated mainly by CYP2C19. Loss-of-function alleles CYP2C19*2 (~15% Caucasian / ~25-30% East Asian) and *3 (rare in Caucasian, ~5% East Asian) reduce active metabolite formation and antiplatelet response — ‘clopidogrel non-responders’ have measurably higher stent thrombosis and recurrent ACS rates. FDA added a boxed warning in 2010 advising consideration of alternative antiplatelets in known poor metabolisers; many cardiac centres now genotype before PCI. Where genotyping is available and CYP2C19 poor-metaboliser status is confirmed, ticagrelor or prasugrel are the alternatives; ticagrelor (NICE TA236) is the more common switch in the UK NHS. PPI co-prescription is the second major interaction: omeprazole and esomeprazole inhibit CYP2C19 and reduce clopidogrel active metabolite formation in vitro and in some clinical studies. The FDA boxed-warning era favoured avoiding omeprazole/esomeprazole with clopidogrel; current pragmatic guidance (BSG, NICE) is to use pantoprazole, lansoprazole or rabeprazole where PPI cover is indicated for high GI-bleed risk. Bleeding risk is the universal safety signal: do not initiate or continue without bleeding-risk assessment (HAS-BLED or local equivalent); withhold 5-7 days before elective surgery; reverse with platelet transfusion in emergency bleeding (no specific antidote). DAPT plus oral anticoagulation triple therapy duration is the high-risk prescribing zone and requires cardiology and haematology coordination. Discontinue 5-7 days pre-surgery for elective; bridge with short-acting agents in high-risk patients per ACC/AHA periprocedural guidance. Cross-class allergy: prasugrel and ticagrelor have different mechanisms but clopidogrel hypersensitivity (rash 4-6%, rare DRESS / TTP) warrants caution before class switching. M Care does not provide clinical advice — the destination-country regulator's SmPC, NICE TA210/TA213/TA236/TA317 guidance, and the local cardiology formulary are the prescribing references.
Five regulatory tracks for an Indian-manufactured clopidogrel export.
Clopidogrel is registered in 100+ countries via Indian generic manufacturers, off-patent globally since 2012. The dossier work for any new market is typically CTD Module 1 country-specific assembly plus Module 3 reuse. The molecule-specific regulatory hotspots are CYP2C19 prescribing-information alignment and the post-2009 PPI-interaction SmPC framework.
WHO Essential Medicines List
Clopidogrel is on the WHO Model List of Essential Medicines (23rd edition, 2023) as a core-list antiplatelet for cardiovascular and cerebrovascular indications. WHO EML status is the gateway to WHO Prequalification assessment and Global Fund cardiovascular-comorbidity tender eligibility. Multiple Indian clopidogrel generic manufacturers hold active WHO PQ status. The WHO HEARTS technical package and the Global Burden of Disease IHD reduction targets identify clopidogrel as essential secondary-prevention infrastructure.
MHRA (United Kingdom)
Clopidogrel is registered with the MHRA across multiple PL holders covering 75mg and 300mg strengths. NHS Drug Tariff Category M generic dispensing applies. NICE TA210 (clopidogrel and modified-release dipyridamole for ACS, 2010) and NICE TA213 (clopidogrel and modified-release dipyridamole for stroke secondary prevention, 2010) are the reference technology appraisals. MHRA Drug Safety Update 2009 on the clopidogrel-PPI interaction recommends pantoprazole or histamine-2 receptor antagonist where gastroprotection is needed; this is reflected verbatim in current UK SmPCs.
EMA (European Union) and EU member states
Decentralised Procedure or Mutual Recognition Procedure registrations across EU/EEA via national medicines agencies. Article 40 importation licence via partner MIA(IMP) holder for non-EEA-manufactured supply with EU-zone QP batch release. The EMA SmPC harmonised guidance on CYP2C19 polymorphism and the PPI interaction is the European reference; pantoprazole is the preferred PPI co-prescription. Brexit-era post-2021 supply requires the standard EU Article 40 import licence pathway.
GCC and Middle East
Gulf Health Council Central Registration route covering KSA, UAE, Kuwait, Qatar, Oman, Bahrain. State-by-state where Central Registration not in scope: SFDA (KSA), MoHAP/DHA (UAE), CMSPS (Kuwait), MoPH (Qatar), MoH/OFDA (Oman), NHRA (Bahrain). Clopidogrel is on every state's essential medicines list and on the Saudi NCD initiative Mandatory Reserve List. NUPCO framework responses for large hospital tenders with three-manufacturer redundancy. Arabic SmPC carries the CYP2C19 and PPI-interaction warnings translated from the SFDA reference label.
African and LMIC markets
NAFDAC (Nigeria), PPB (Kenya), FDA Ghana, SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania), NDA (Uganda) registration pathways. WHO Prequalification opens donor-funded pooled procurement at concessional pricing for Global Fund HIV-CVD comorbidity, PEPFAR essential-medicines and World Bank-funded NCD programmes. African public-sector formulary committees increasingly include CYP2C19 genotyping discussion in clopidogrel stewardship; M Care can supply the pharmacogenomic-aware SmPC overlay where formulary committees request it.
Clopidogrel's tender-line and clinical companion molecules.
Antiplatelet tenders rarely come single-line. Clopidogrel pairs with aspirin in DAPT, with statins in secondary prevention, and sits adjacent to the ARB / CCB / beta-blocker antihypertensive backbone. Internal links to the molecules and services already covered.
Atorvastatin
HMG-CoA reductase inhibitor. The reflexive ACS / PCI co-prescription with clopidogrel. NICE TA385 secondary prevention.
Amlodipine
Dihydropyridine CCB. Antihypertensive companion to clopidogrel in CAD secondary prevention. NICE NG136 Step 2.
Losartan
Angiotensin receptor blocker. NICE NG136 first-line antihypertensive paired with clopidogrel in post-ACS hypertension control.
Cardiovascular cluster
Antiplatelets, anticoagulants, antihypertensives (ARBs, CCBs, beta-blockers, diuretics), statins, antiarrhythmics. Cardiovascular tender lines are rarely single-molecule.
GCC tender response service
SFDA, NUPCO and state-by-state tender desks for clopidogrel alongside the broader cardiovascular pack. Three-manufacturer-redundancy quotes.
NHS tender response service
Acute trust hospital pack 28-count blisters for ACS DAPT initiation, plus Cat M community pharmacy chain supply.
How a clopidogrel enquiry becomes a sustained supply contract.
- Send us the specifics. WhatsApp the Mumbai line or send the contact form. We need destination country, strengths required (75mg / 300mg, single or multi), per-month or per-tender volume, buyer profile (NHS framework, GCC tender desk, African MoH, NGO, EU community-pharmacy chain), and whether aspirin + clopidogrel FDC combinations are needed for DAPT initiation packs. Reply within one working day with a provisional quote and the Indian partner manufacturer best-fit.
- Three-manufacturer-redundancy quote. M Care quotes three Indian partner manufacturers per dose-strength for tender-supply redundancy. Pricing FOB Mumbai or CIF destination port, packaged in destination-language blister or HDPE bottle per buyer specification. Quote includes per-tablet ex-works pricing, freight, dossier preparation fee (if new registration), and destination-country regulatory fees (passed through at cost). FDC combinations quoted on a separate workflow. Quote validity 30 days from issue.
- Dossier preparation. For existing registrations, M Care provides batch-specific CoA, CoPP per WHO format, related-substances impurity profile to ICH Q3A, and SmPC/PIL country overlay within 5-10 working days from PO. For new-market registration, we assemble the full CTD Module 1-5 dossier — Module 3 quality data is partner-manufacturer-specific and reused; Module 1 administrative is country-specific. Typical full-dossier preparation 30-45 working days; new-market regulatory review 6-18 months depending on backlog. CYP2C19 / PPI-interaction SmPC overlay handled per destination regulator's reference label.
- Manufacturing campaign and freight. Stock-line 75mg ships from existing manufacturer inventory in 10-14 working days from PO. 300mg loading-dose strength typically 14-21 working days. Tender quantities >1M tablets per dose-strength require dedicated campaign batches with 4-6 week PO-to-shipment timeline. Air freight via Mumbai / Delhi for time-critical orders; sea freight LCL/FCL via Nhava Sheva for tender volumes. Customs clearance handled by buyer with M Care providing commercial invoice, packing list, CoA, CoPP, Form 14.
- Ongoing supply and pharmacovigilance. Post-shipment: M Care provides monthly Drug Tariff line confirmation for UK NHS buyers, SFDA / NUPCO monthly availability confirmations for GCC tender desks, and CSV / Excel tender-line trackers for African public-sector buyers. Pharmacovigilance reporting (UK Yellow Card / EU EudraVigilance / SFDA NPC / NAFDAC) is the partner manufacturer's MAH responsibility; M Care coordinates local responsible person paperwork. Quarterly CTD Module 3 update review to ensure dossier currency. PSURs on the ICH-E2C(R2) cycle.
Clopidogrel tablet supply — buyer FAQ.
What strengths of clopidogrel do M Care supply?
75mg maintenance dose and 300mg loading-dose film-coated tablets — the two global strengths registered across MHRA, EMA, SFDA, MOHAP, SAHPRA, NAFDAC and BfArM. 75mg is the high-volume tender line covering maintenance DAPT, stroke secondary prevention and stable CAD; 300mg is the ACS / PCI loading-dose strength supplied in hospital-pack 28-count blisters for acute trust DAPT initiation packs on request. Some centres use 600mg loading (eight 75mg or two 300mg) but the SmPC reference loading dose is 300mg. All tablets supplied as scored or unscored film-coated per market specification, in HDPE bottles or destination-language blister packaging.
Are M Care's clopidogrel lines tested for the related-substance impurity profile?
Yes. Clopidogrel finished-dosage manufacturing has historically required tight related-substance control under ICH Q3A — the molecule has well-characterised oxidation and hydrolysis degradants that the BP/USP/EP monographs specify limits for. Every batch of M Care-supplied clopidogrel is tested for the full related-substance impurity profile and dissolution per the destination-pharmacopoeia monograph; the test certificate accompanies every shipment. The Indian partner manufacturers on the M Care roster have active EU-GMP audits for clopidogrel finished-dosage and operate under tight related-substance specifications aligned with current EU pharmacopoeia limits.
How do you handle the clopidogrel CYP2C19 pharmacogenomic prescribing question?
Clopidogrel is a prodrug bioactivated mainly by hepatic CYP2C19. Loss-of-function alleles (*2 / *3 — prevalence approximately 25-30% in East Asian populations and 15-20% in Caucasian, lower in African) reduce active metabolite formation and antiplatelet response, with measurably higher stent thrombosis and recurrent ACS rates in confirmed poor metabolisers. The FDA added a boxed warning in 2010 advising consideration of alternative antiplatelets in known poor metabolisers. Our destination-language PIL carries the CYP2C19 polymorphism warning verbatim from the reference SmPC. Where the destination market's cardiology centres genotype before PCI, ticagrelor (NICE TA236) or prasugrel (NICE TA317) are the alternatives — M Care can supply the ticagrelor / prasugrel finished-dosage lines on a separate workflow if the tender pivots.
What's the prescribing guidance for clopidogrel with PPIs?
Omeprazole and esomeprazole inhibit CYP2C19 and reduce clopidogrel active metabolite formation in vitro and in some clinical studies. The FDA boxed-warning era (2009-2010) favoured avoiding the combination. Current pragmatic guidance (MHRA Drug Safety Update 2009, EMA SmPC harmonised guidance, NICE) is to use pantoprazole, lansoprazole or rabeprazole where PPI cover is indicated for high GI-bleed risk on DAPT. M Care's destination-language PIL carries this verbatim from the reference label. Where the destination market formulary needs pantoprazole supply alongside clopidogrel, M Care can supply both molecules on combined shipments — see gastroenterology for the PPI line.
Can M Care supply aspirin + clopidogrel fixed-dose combinations for DAPT initiation packs?
Yes — aspirin + clopidogrel FDC combinations (typically aspirin 75mg + clopidogrel 75mg fixed-dose tablets, or co-packaged DAPT initiation packs) are available from M Care's partner manufacturer network. FDC combinations are quoted on a separate workflow because they require a separate Module 1 regulatory dossier per destination, follow the FDC partner manufacturer's campaign cadence (typically 21-28 working days vs single-molecule 10-14), and have different per-tablet pricing. The co-packaged DAPT initiation pack (separate aspirin and clopidogrel tablets in a single hospital blister) is also available and is the preferred format for UK acute trust ACS DAPT initiation.
Is clopidogrel a controlled drug or schedule-restricted in any market?
No. Clopidogrel is a standard prescription-only medicine (POM) in every regulated market and is not controlled, scheduled or otherwise restricted under the UN Single Convention or UN Convention on Psychotropic Substances. No special transport, customs or destination-country licensing requirements beyond standard pharmaceutical import paperwork. Standard ambient transport with desiccant for tropical destinations. No reefer container, no GDP cold-chain validation pack.
What's the typical lead time and minimum order quantity?
Stock items 75mg ship in 10-14 working days from PO ex-Mumbai. 300mg loading-dose strength typically 14-21 working days. Tender quantities >1M tablets per dose-strength require campaign batch scheduling — 4-6 weeks from PO. Named-patient and small-volume orders for hospital pharmacy ship in 5-7 working days from existing campaign stock. Minimum order quantity is buyer- and channel-specific: NHS Cat M dispensing has no MOQ; GCC tender desks typically 100K+ tablets per dose-strength; African public-sector procurement typically 500K+ tablets per dose-strength.
Clopidogrel tablet — three-manufacturer-redundancy supply for the NICE TA210 ACS pathway, NICE TA213 stroke pathway and GCC / African cardiovascular tender lines.
Clopidogrel is everyday — global, generic, high-volume — and the buyer-side complexity is in the CYP2C19 pharmacogenomic SmPC alignment, the PPI-interaction guidance, and the aspirin co-pack / FDC formats for DAPT initiation. M Care holds three Indian partner manufacturers per dose-strength for supply redundancy, with NHS Cat M, SFDA, NUPCO, NAFDAC, KEMSA, SAHPRA, and EU MIA(IMP) registrations all on file or readily assembled.