Amlodipine tablet — Indian WHO-GMP supply for the NICE NG136 first-line antihypertensive in the UK NHS, GCC and Africa.
Long-acting dihydropyridine calcium channel blocker and the global reference vasodilatory antihypertensive. NICE NG136 first-line monotherapy for adults aged >55 or of Black African or Caribbean family origin at any age. Once-daily dosing with 30-50 hour half-life, peripheral-selective vasodilatation, minimal negative inotropy. Standard agent for stable angina and Prinzmetal (vasospastic) angina. Top-five-most-prescribed drug in the UK NHS by volume per OpenPrescribing. 2.5mg, 5mg and 10mg amlodipine besylate film-coated tablets from Indian WHO-GMP facilities. NHS Drug Tariff Category M generic dispensing scale. Multiple partner lines under WHO Prequalification.
Multiple WHO-GMP partner lines · 2.5mg / 5mg / 10mg amlodipine besylate film-coated tablets · CTD dossier on file · NHS NG136 Step 1A first-line · Top-5 most-prescribed UK NHS drug by volume.
Active ingredient
Amlodipine besylate — the besylate salt form is the global API standard for tablet stability (a small fraction of generics use mesylate; M Care supplies the besylate form unless the destination registration specifies otherwise). Mechanism: selective L-type Ca2+ channel antagonism in vascular smooth muscle preferentially over cardiac muscle, producing peripheral arterial vasodilatation with minimal effect on contractility, conduction or heart rate. The long 30-50 hour elimination half-life provides smooth 24-hour BP control with resistance to dose-skip rebound — a clinical advantage in adherence-challenged populations. M Care does not hold FDA or TGA registrations for this molecule.
Strengths stocked
2.5mg film-coated tablet — paediatric and titration-start dose; recommended starting dose for elderly >75 or hepatic-impaired adults. 5mg film-coated tablet — standard adult monotherapy starting dose for hypertension and stable angina; the highest-volume tender-line dose. 10mg film-coated tablet — maximum monotherapy dose; titration target for inadequate response to 5mg. All three strengths supplied as scored or unscored film-coated tablets per market specification, in HDPE bottles or destination-language blister packaging. Combination product context: amlodipine is also widely tendered in fixed-dose combinations with atorvastatin (Caduet), perindopril, telmisartan, valsartan and olmesartan — M Care can quote the FDC supply lines on a separate workflow.
Indications scope
Essential hypertension as NICE NG136 Step 1A first-line for adults >55 or of Black African or Caribbean family origin (any age), then Step 2 in combination with an ACE inhibitor or ARB for adults of any age. Step 3 combination with a thiazide-like diuretic. Stable angina pectoris and vasospastic (Prinzmetal) angina, alongside or in place of beta-blockers. Combined hypertension and ischaemic heart disease as single-agent dual management. Paediatric hypertension at age-adjusted dosing. ACE intolerance hypertension. The NHS GP formulary uses amlodipine as the default CCB; alternatives (felodipine, nifedipine LA, lercanidipine) typically only when amlodipine is not tolerated due to peripheral oedema.
Buyer fit
UK NHS community pharmacy at NHS Drug Tariff Category M reimbursement scale — top-five most-prescribed drug by volume per OpenPrescribing data. GCC hypertension tender desks — Saudi Arabia (NUPCO, SFDA-registered), UAE (MoHAP, DHA), Kuwait (CMSPS), Qatar (Hamad Medical Corporation, MoPH), Oman (MoH, OFDA), Bahrain (NHRA). African public-sector procurement — Nigeria (NAFDAC, FHC), Kenya (KEMSA, PPB), Ghana (FDA, GHS), South Africa (SAHPRA, NDoH), Ethiopia (EFDA), Tanzania (MSD, TMDA). EU EU-GMP-route community pharmacy and tender chains. NGO and humanitarian procurement — Global Fund cardiovascular comorbidity programmes, MSF essential medicines.
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, Summary of Product Characteristics (SmPC) per destination regulator's format, Patient Information Leaflet (PIL) with destination-language translation where required, full CTD Module 1-5 dossier for new-market registration submission, NHS Drug Tariff line confirmation for UK community-pharmacy buyers, and combination-product feasibility note where the destination tender or formulary uses an FDC partner.
Lead times
Stock items 5mg and 10mg ship in 10-14 working days from PO ex-Mumbai. 2.5mg paediatric 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. FDC combinations (amlodipine + atorvastatin, amlodipine + perindopril, etc.) ship on the FDC partner manufacturer's campaign cadence — typically 21-28 working days.
Four buyer-channel models for an amlodipine pharmaceutical export from India
Pharmaceutical supply isn't one channel. M Care services UK community pharmacy, GCC government tenders, African public-sector procurement and EU/LATAM/SEA contract manufacturing on different paperwork tracks — amlodipine's NHS NG136 first-line status makes it volume-dominant in primary-care community-pharmacy lanes globally.
UK NHS community pharmacy
NHS Drug Tariff Category M generic dispensing — amlodipine is the highest-volume Cat M cardiovascular line in primary-care England per OpenPrescribing data (~30M prescriptions/year for 5mg + 10mg combined). 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, and Article 40 / EU-IMPD release pathway through partner UK MIA(IMP) holders for non-EEA imports post-Brexit. Pricing follows Cat M reimbursement bands; NHS BSA monthly Drug Tariff updates dictate margin discipline.
GCC government 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). M Care has the CTD M1 country-specific overlay packs ready and Arabic SmPC + PIL translations on file. Tender-line dosing is typically 5mg and 10mg at high volumes; 2.5mg paediatric at lower tender volumes. NUPCO framework response timelines are 14-21 days from RFQ; we hold three Indian partner manufacturers with active SFDA registrations to give NUPCO desks supply-redundancy. FDC combinations (amlodipine+atorvastatin, amlodipine+olmesartan) on separate quotes.
African public-sector procurement
NAFDAC (Nigeria), PPB (Kenya), FDA (Ghana), SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania) registration pathways. WHO Prequalification active for several Indian amlodipine generic lines, opening Global Fund cardiovascular comorbidity procurement (HIV-CVD comorbidity essential-medicines basket per WHO 2023 guidance) and UNFPA reproductive-health hypertension donor lines at concessional prices. Sea-freight LCL/FCL via Mumbai/Nhava Sheva to Lagos / Mombasa / Durban / Dar es Salaam is the standard logistics lane; 6-8 week sea transit with FFP and pre-shipment QC sampling.
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) registration pathways; SEA via Philippines FDA, Vietnam DAV, Indonesia BPOM, Malaysia NPRA, Bangladesh DGDA, Sri Lanka NMRA. Amlodipine is registered in 100+ countries via Indian generic manufacturers; M Care's role is dossier and tender-pack assembly, not standalone manufacturing — partner manufacturers handle the API and finished-dosage. Combination products (FDC) require a separate Module 1 dossier per regulator.
Once-daily anytime, peripheral oedema as discontinuation driver, simvastatin 20mg ceiling, NICE NG136 step-up discipline — amlodipine is everyday but the prescribing nuances matter.
Adult starting dose 5mg/day for hypertension and stable angina; 2.5mg/day starting in elderly >75 years, hepatic-impaired adults, and paediatric hypertension. Titration target 10mg/day after 2-4 weeks if BP response inadequate. Once-daily dosing at any time of day — amlodipine's 30-50 hour elimination half-life and lipophilic-membrane reservoir give it the most resistance to dose-skip rebound of any oral antihypertensive class, so adherence-challenged patients still get smooth 24-hour BP control. Peripheral oedema is the most common discontinuation driver — incidence approximately 5-10% at 10mg, less at 5mg, dose-dependent. Counsel patients that ankle oedema reflects vasodilatation-induced capillary leak (NOT fluid overload) and does NOT respond to diuretics — adding furosemide or thiazide at higher dose is a common but incorrect first reflex. Switch to an alternative CCB (lercanidipine has lower oedema incidence) or step down to 5mg + add ACE inhibitor instead. Simvastatin interaction is the single most-flagged item on amlodipine PILs — MHRA advises simvastatin ≤20mg/day when co-prescribed with amlodipine ≤10mg/day due to CYP3A4 inhibition increasing simvastatin AUC and rhabdomyolysis risk. Atorvastatin and rosuvastatin are NOT subject to this restriction (different metabolism profiles) and are often the safer co-prescribing choice. Grapefruit juice in moderation is acceptable; amlodipine has weaker CYP3A4 sensitivity than simvastatin so the interaction is clinically minor at typical dietary intakes. Beta-blocker co-administration in stable angina is acceptable (amlodipine's vascular-selectivity over cardiac means minimal additive cardiac depression) — a key contrast versus diltiazem or verapamil where beta-blocker combination is contraindicated. Pregnancy is generally avoided (former Category C; switch to labetalol or methyldopa per NICE NG133) although small-cohort data on amlodipine in pregnancy hypertension does not show major teratogenicity. Renal impairment requires no dose adjustment — amlodipine is hepatically metabolised. Hepatic impairment: start at 2.5mg and titrate slowly; clearance is reduced. NICE NG136 step-up discipline: do not push to 10mg before titrating to 5mg for 2-4 weeks; do not start a second agent before establishing baseline 5-10mg response; do not skip Step 2 to Step 3 (CCB+thiazide) — the NICE pathway sequence is evidence-based and ICS audited. M Care does not provide clinical advice — local prescribing formulary, MHRA Drug Safety Updates, and the destination-country regulator's SmPC are the prescribing references.
Five regulatory tracks for an Indian-manufactured amlodipine pharmaceutical export
Amlodipine is registered in 100+ countries via Indian generic manufacturers. The dossier work for any new market is typically CTD Module 1 country-specific assembly plus Module 3 reuse — Modules 2-5 don't change between destinations. Combination products require a separate Module 1 dossier track per regulator.
WHO Essential Medicines List
Amlodipine is on the WHO Model List of Essential Medicines (23rd edition, 2023) as a representative of the dihydropyridine calcium channel blocker class. WHO EML status is the gateway to WHO Prequalification assessment and Global Fund cardiovascular-comorbidity tender eligibility (HIV-CVD comorbidity essential-medicines basket per WHO 2023 guidance) — multiple Indian amlodipine generic manufacturers hold active WHO PQ status, including paediatric strengths.
MHRA (United Kingdom)
Amlodipine is registered with the MHRA across multiple PL holders covering 2.5mg, 5mg and 10mg strengths. NHS Drug Tariff Category M generic dispensing applies — Cat M reimbursement bands updated monthly by NHS BSA. Amlodipine is named in NICE Hypertension Guideline NG136 as a NICE-preferred CCB; alternatives (felodipine, nifedipine LA, lercanidipine) are reserved for amlodipine-intolerance cases. MHRA Drug Safety Update 2012 on amlodipine + simvastatin interaction (≤20mg/day simvastatin ceiling) remains in current SmPC.
EMA (European Union) and EU member states
Decentralised Procedure or Mutual Recognition Procedure registrations across EU/EEA via national medicines agencies (BfArM, ANSM, AIFA, AEMPS, MEB, FAMHP, etc.). EU Reference Member State (RMS) typically Germany or the Netherlands for new generic amlodipine dossiers. Article 40 importation licence via partner MIA(IMP) holder for non-EEA-manufactured supply with EU-zone QP batch release. Combination products (FDC) require a separate dossier track per FDC partner.
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). Amlodipine is on every state's essential medicines list. NUPCO framework responses for large hospital tenders; private-sector retail registrations alongside. Saudi NCD initiative places amlodipine on Mandatory Reserve List for primary-care hypertension management.
African and LMIC markets
NAFDAC (Nigeria), PPB (Kenya), FDA Ghana, SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania), NDA (Uganda), NRA (Rwanda) registration pathways. WHO Prequalification opens donor-funded pooled procurement at concessional pricing for Global Fund HIV-CVD comorbidity, UNFPA hypertension-in-pregnancy and PEPFAR essential-medicines programmes. WHO HEARTS technical package recommends amlodipine alongside ACE inhibitors as the global hypertension primary-care backbone.
Pharmacovigilance and adverse-event reporting
Amlodipine is post-marketing surveillance in every regulated market. UK Yellow Card scheme, EU EudraVigilance, SFDA NPC (KSA), NAFDAC PV unit — all handled by the MAH or Indian manufacturer's local responsible person. Reporting timelines are 15 days for serious unexpected adverse reactions and 90 days for non-serious per ICH-E2D. Periodic Safety Update Reports (PSURs) on the standard ICH-E2C(R2) cycle. The most-frequent ADR signal is peripheral oedema (5-10% incidence at 10mg) — well-characterised and not a re-classification trigger.
Amlodipine's tender-line and clinical companion molecules
Hypertension tenders are rarely single-line. Amlodipine pairs with statins, ACE inhibitors, ARBs and diuretics across the NICE NG136 step-up. Internal links to the molecules and services we already cover.
Atorvastatin
HMG-CoA reductase inhibitor (statin). Cardiovascular comorbidity tender pairing — amlodipine + atorvastatin is the most-prescribed FDC combination globally (Caduet generic). Most-prescribed UK NHS drug by volume.
Cardiovascular cluster overview
Antihypertensives (ARBs, CCBs, beta-blockers, diuretics), antiplatelets, anticoagulants, antiarrhythmics, lipid-lowering agents. Hypertension tender-line procurement is rarely single-molecule.
Diabetes-endocrine overlap
Diabetes-cardiovascular comorbidity tender pairing — hypertension is more prevalent in T2DM and amlodipine is a NICE NG28 acceptable CCB choice in patients with diabetic nephropathy.
Named-patient import (UK)
MHRA Specials and named-patient pathway for paediatric hypertension cases requiring a strength not registered in the UK, or for individual-patient import requests by Indian manufacturer brand name.
GCC tender response service
SFDA, NUPCO and state-by-state tender desks for amlodipine alongside the broader cardiovascular pack. 14-21 day turnaround from RFQ to bid with three-manufacturer-redundancy quotes.
EU-GMP import workflow
Amlodipine into Germany, France, Italy, Spain, the Netherlands and Belgium via partner MIA(IMP) holders with QP batch release. Article 40 importation licence and EU CTD overlay handled.
How an amlodipine enquiry becomes a sustained supply contract
- Send us the specifics. WhatsApp the Mumbai line or send the contact form. We need the destination country, the strengths required (2.5mg / 5mg / 10mg, single or multi), the per-month or per-tender volume, the buyer profile (NHS framework, GCC tender desk, African MoH, NGO, EU community-pharmacy chain), and whether any FDC combinations are required (amlodipine+atorvastatin, amlodipine+perindopril, amlodipine+olmesartan). Reply within one working day with a provisional quote and a confirmation of which Indian partner manufacturer is best-fit.
- Three-manufacturer-redundancy quote. M Care quotes three Indian partner manufacturers per dose-strength for tender-supply redundancy. Pricing is FOB Mumbai or CIF destination port, packaged in destination-language blister or bottle per buyer specification. Quote includes per-tablet ex-works pricing, freight to destination, dossier preparation fee (if new registration), and any destination-country regulatory fees (typically passed through at cost). FDC combination products quoted on a separate workflow due to FDC partner manufacturer cadence. Quote validity is 30 days from issue.
- Dossier preparation. For existing registrations, M Care provides batch-specific CoA, CoPP per WHO format, 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 across markets; Module 1 administrative is country-specific and re-overlaid per destination regulator (MHRA, EMA, SFDA, NAFDAC, etc.). Typical full-dossier preparation timeline is 30-45 working days; new-market regulatory review is 6-18 months depending on regulator backlog. FDC combinations require a parallel Module 1 dossier track.
- Manufacturing campaign and freight. Stock-line strengths (5mg, 10mg) ship from existing manufacturer inventory in 10-14 working days from PO. 2.5mg paediatric strength typically requires campaign batch scheduling — 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 for tender volumes via Nhava Sheva for AAA-class container shipping. Destination customs clearance handled by buyer with M Care providing import licence support paperwork (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 Yellow Card / EudraVigilance / NPC reporting is the partner manufacturer's MAH responsibility; M Care coordinates the local responsible person paperwork. Quarterly CTD Module 3 update reviews to ensure dossier currency. Periodic Safety Update Reports (PSUR) on the ICH-E2C(R2) cycle for EU/UK markets. Combination-product pharmacovigilance handled separately on the FDC partner's MAH cycle.
Amlodipine tablet supply — buyer FAQ
What strengths of amlodipine do M Care supply?
2.5mg, 5mg and 10mg amlodipine besylate film-coated tablets — the three global strengths registered across all major regulators. 5mg and 10mg are the high-volume tender lines; 2.5mg is the paediatric and elderly-titration starting strength. All three supplied as scored or unscored film-coated tablets per market specification, in HDPE bottles or destination-language blister packaging. The besylate salt form is the global API standard; mesylate is supplied only for specific destination registrations that require it.
Can M Care supply amlodipine fixed-dose combinations (FDC)?
Yes — amlodipine + atorvastatin (Caduet generic), amlodipine + perindopril, amlodipine + telmisartan, amlodipine + valsartan, amlodipine + olmesartan are all 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 structures. Specify the FDC partner and dose-ratio in the enquiry and we'll quote on the FDC manufacturer best-fit.
Is amlodipine a controlled drug or schedule-restricted in any market?
No — amlodipine is a standard prescription-only medicine (POM) in every regulated market and is not controlled, scheduled or otherwise restricted under the UN Single Convention on Narcotic Drugs or the UN Convention on Psychotropic Substances. No special transport, customs or destination-country licensing requirements beyond standard pharmaceutical import paperwork. No cold-chain required — ambient transport with standard desiccant for tropical destinations.
How does amlodipine compare with other dihydropyridine CCBs in tender pricing?
Amlodipine dominates dihydropyridine CCB tender volumes by approximately 8:1 over felodipine, 5:1 over nifedipine extended-release, and 10:1 over lercanidipine in NHS dispensing data. Pricing per defined daily dose (DDD) is lowest for amlodipine due to the longest off-patent maturity (since 2007 globally) and highest production scale. Lercanidipine has lower peripheral-oedema incidence and may be preferred where the original amlodipine line caused intolerable oedema; nifedipine LA is occasionally preferred for vasospastic angina. M Care supplies all four classes — atorvastatin / amlodipine / lercanidipine / nifedipine LA — but amlodipine is the volume default.
Are M Care's amlodipine lines WHO Prequalified?
Multiple Indian generic amlodipine manufacturers in M Care's partner network hold active WHO Prequalification status, including paediatric strength formulations. WHO PQ opens Global Fund cardiovascular-comorbidity pooled procurement (HIV-CVD comorbidity essential-medicines basket per WHO 2023 guidance), UNFPA hypertension-in-pregnancy programmes, and PEPFAR essential-medicines tenders at concessional pricing. The specific WHO PQ-listed manufacturer for any given tender response depends on the destination country, dose strength and per-tender volume — quote responses cite the WHO PQ status of each line specifically.
What's the typical lead time and minimum order quantity?
Stock items 5mg and 10mg ship in 10-14 working days from PO ex-Mumbai. 2.5mg paediatric 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 — no MOQ; GCC tender desks — typically 100K+ tablets per dose-strength; African public-sector procurement — typically 500K+ tablets per dose-strength.
Does amlodipine need cold-chain shipping or special storage?
No cold-chain required. Amlodipine besylate film-coated tablets store at below 25°C in original blister or HDPE container, protect from moisture and light. Standard ambient transport applies — including for tropical destinations, where desiccant is included in the bottle / blister cassette to manage humidity excursion. No temperature-monitored shipping required, no reefer container, no GDP cold-chain validation pack. Air freight or sea freight via standard pharmaceutical lanes (Mumbai or Nhava Sheva to destination port) is the routine logistics path.
Amlodipine tablet — three-manufacturer-redundancy supply for the NICE NG136 first-line antihypertensive in the UK NHS, GCC and Africa.
Amlodipine is everyday — global, generic, high-volume — and the buyer-side complexity is in the tender pack and the FDC combinations. 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.