Atorvastatin tablet — Indian WHO-GMP supply for the most-prescribed cardiovascular drug in the UK NHS.
Synthetic high-intensity HMG-CoA reductase inhibitor and the global statin reference for cardiovascular risk reduction. LDL-C reduction approximately 38-55% at 40-80mg high-intensity dosing per ACC/AHA 2018. Standard first-line for primary hypercholesterolaemia, primary CV-event prevention in adults with QRISK3 ≥10% per NICE CG181, secondary prevention post-MI per IDEAL/TNT/PROVE-IT, secondary prevention post-stroke 16% relative reduction per SPARCL, and primary prevention in T2DM per NICE NG28. 10mg, 20mg, 40mg and 80mg 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 · 10mg / 20mg / 40mg / 80mg film-coated tablets · CTD dossier on file · NHS Drug Tariff Cat M scale · Cardiovascular Outcomes Trial body deepest of any lipid-lowering agent.
Active ingredient
Atorvastatin presented as the calcium trihydrate salt form for tablet stability — a synthetic, fully reversible competitive inhibitor of HMG-CoA reductase. Mechanism: blockade of the rate-limiting step in hepatic cholesterol synthesis, depletion of intra-hepatocyte cholesterol pool, upregulation of LDL receptor expression, and accelerated clearance of circulating LDL-C. Active metabolites (ortho- and para-hydroxy atorvastatin) extend pharmacological half-life to 20-30 hours, supporting any-time-of-day dosing — unlike short-half-life statins (simvastatin, lovastatin) which require evening administration. M Care does not hold FDA or TGA registrations for this molecule.
Strengths stocked
10mg film-coated tablet — moderate-intensity starting dose, NICE primary prevention default in adults with QRISK3 ≥10%. 20mg film-coated tablet — moderate-intensity titration target and the NHS-preferred first-line dose for adults with established CV disease per NICE CG181. 40mg film-coated tablet — high-intensity dosing for secondary prevention, FH adolescents, and inadequate response to 20mg. 80mg film-coated tablet — high-intensity dosing for the post-MI / post-stroke evidence-base (TNT, PROVE-IT, SPARCL trials), homozygous FH adjunct therapy, and aggressive LDL-C lowering per ACC/AHA 2018 guidelines. All four strengths supplied as scored or unscored film-coated tablets per market requirement.
Indications scope
Primary hypercholesterolaemia, mixed dyslipidaemia, heterozygous familial hypercholesterolaemia, homozygous FH adjunct, primary CV-event prevention in adults with elevated 10-year risk (QRISK3 ≥10% per NICE), secondary prevention post-myocardial infarction (TNT / IDEAL / PROVE-IT high-intensity evidence), secondary prevention post-ischaemic stroke or TIA (SPARCL 80mg), primary prevention in type 2 diabetes with additional risk factors (NICE NG28), and lipid-lowering in chronic kidney disease stages 3-5 not on dialysis (NICE NG203). The NHS does not routinely commission atorvastatin for primary prevention below the 10% QRISK3 threshold — referral pathway differs by ICS.
Buyer fit
UK NHS community pharmacy at NHS Drug Tariff Category M reimbursement scale — the highest-volume primary-care dispensing line in the country (>50 million prescriptions/year per OpenPrescribing primary-care dispensing data). GCC cardiovascular 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, GAVI, MSF cardiovascular essential-medicines programmes.
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 registration submission, and NHS Drug Tariff line confirmation for UK community-pharmacy buyers.
Lead times
Stock items 10mg and 20mg ship in 10-14 working days from PO ex-Mumbai. 40mg and 80mg high-intensity strengths typically 14-21 working days depending on partner manufacturer and current campaign. 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 atorvastatin 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 — atorvastatin's global ubiquity makes it cross-channel in volume.
UK NHS community pharmacy
NHS Drug Tariff Category M generic dispensing — atorvastatin is the highest-volume Cat M line in primary-care England per OpenPrescribing data (>50M prescriptions/year). 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 20mg and 40mg at high volumes; 10mg and 80mg 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.
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 atorvastatin generic lines, opening Global Fund, UNFPA and GAVI pooled procurement at concessional prices for low- and middle-income country donor programmes. 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. Atorvastatin 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.
Any-time dosing, muscle symptom triage, statin-induced T2DM counselling, NHS preferred-source discipline — atorvastatin is high-volume but nuance is in the chronic care.
Adult primary prevention starting dose 20mg/day per NICE CG181 for QRISK3 ≥10%; 10mg/day in selected lower-risk profiles; 40mg or 80mg/day high-intensity for secondary prevention. Paediatric heterozygous FH age 10-17: 10mg/day starting, titrate to 20mg per FH pathway. Any-time-of-day administration — atorvastatin's parent half-life is 14 hours and active-metabolite half-life is 20-30 hours, so unlike simvastatin/lovastatin (short half-life requiring evening dosing for nocturnal HMG-CoA peak alignment), atorvastatin can be taken at whichever time supports adherence. Muscle symptoms are the most common discontinuation reason: triage with creatine kinase (CK) measurement first — myalgia without CK rise is rarely true myopathy and often resolves with rechallenge or alternate-day dosing. Rhabdomyolysis is rare (<0.1%) but accelerated by CYP3A4 inhibitors — the high-risk interaction list includes clarithromycin and erythromycin (avoid or hold statin), itraconazole and ketoconazole (avoid), HIV protease inhibitors (avoid), ciclosporin (avoid combination), and gemfibrozil (avoid; use fenofibrate if combination indicated). Grapefruit juice in moderation (≤200ml/day) is acceptable; ≥1L daily increases atorvastatin AUC ~2.5-fold and is contraindicated in tender PILs. Statin-induced new-onset type 2 diabetes incidence is approximately 10-12% increased relative to placebo over 4-6 years at high-intensity dosing — counsel patients but reinforce that the cardiovascular benefit substantially outweighs the diabetogenic risk in primary and secondary prevention populations. Pregnancy is contraindicated (formerly Category X; now MHRA-aligned with NICE pregnancy advice — discontinue 3 months pre-conception). Renal impairment requires no dose adjustment for atorvastatin (unlike rosuvastatin which requires reduction in eGFR <30). Hepatic impairment: caution and LFT monitoring at baseline and 12 weeks; chronic stable transaminitis up to 3× ULN is not a contraindication. NHS preferred-source brand-switching: atorvastatin generics are bioequivalent within standard ±20% AUC limits and are not classified as Narrow Therapeutic Index — generic-to-generic switching is clinically acceptable and routinely done at the community-pharmacy dispensing point. 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 atorvastatin pharmaceutical export
Atorvastatin 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.
WHO Essential Medicines List
Atorvastatin is on the WHO Model List of Essential Medicines (23rd edition, 2023) as a representative of the HMG-CoA reductase inhibitor class. WHO EML status is the gateway to WHO Prequalification assessment and Global Fund / GAVI / UNFPA pooled procurement tender eligibility — multiple Indian atorvastatin generic manufacturers hold active WHO PQ status.
MHRA (United Kingdom)
Atorvastatin is registered with the MHRA across multiple PL holders covering 10mg, 20mg, 40mg and 80mg strengths. NHS Drug Tariff Category M generic dispensing applies — Cat M reimbursement bands updated monthly by NHS BSA. 10mg pharmacy-only (P) reclassification permits over-the-counter sale in the UK for primary prevention in eligible adults under MHRA rule from 2004, although in practice GP prescription dominates dispensing volumes.
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 atorvastatin dossiers. Article 40 importation licence via partner MIA(IMP) holder for non-EEA-manufactured supply with EU-zone QP batch release.
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). Atorvastatin is on every state's essential medicines list. NUPCO framework responses for large hospital tenders; private-sector retail registrations alongside.
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 / UNFPA / GAVI HIV-CV-comorbidity programmes.
Pharmacovigilance and adverse-event reporting
Atorvastatin is post-marketing surveillance in every regulated market. UK Yellow Card scheme, EU EudraVigilance, FDA FAERS (US, where applicable), 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.
Atorvastatin's tender-line and clinical companion molecules
Cardiovascular tenders rarely come single-line. Atorvastatin pairs with antihypertensives, antiplatelets and the diabetes-statin overlap. Internal links to the molecules and services we already cover.
Cardiovascular cluster overview
Antihypertensives (ARBs, CCBs, beta-blockers, diuretics), antiplatelets, anticoagulants, antiarrhythmics, lipid-lowering agents. Cardiovascular tender-line procurement is rarely single-molecule.
Insulin glargine
Long-acting basal insulin analogue. Diabetes-cardiovascular comorbidity tender pairing with atorvastatin per NICE NG28. 100 IU/mL pre-filled pen and cartridge.
Levothyroxine
Synthetic T4 thyroid replacement. The other top-three NHS-prescribed chronic-disease line alongside atorvastatin. 25 to 200 mcg tablets.
Named-patient import (UK)
MHRA Specials and named-patient pathway for paediatric FH 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 atorvastatin alongside the broader cardiovascular pack. 14-21 day turnaround from RFQ to bid with three-manufacturer-redundancy quotes.
EU-GMP import workflow
Atorvastatin 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 atorvastatin 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 (10mg / 20mg / 40mg / 80mg, 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 the dossier scope expected (CTD Module 1 country overlay only, full Module 1-5 dossier for new registration, CoA + CoPP only for existing registration). 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). 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.
- Manufacturing campaign and freight. Stock-line strengths (10mg, 20mg) ship from existing manufacturer inventory in 10-14 working days from PO. High-intensity strengths (40mg, 80mg) typically require 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 / FAERS / 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 for re-registration cycles. Periodic Safety Update Reports (PSUR) on the ICH-E2C(R2) cycle for EU/UK markets.
Atorvastatin tablet supply — buyer FAQ
What strengths of atorvastatin do M Care supply?
10mg, 20mg, 40mg and 80mg film-coated tablets — the four global strengths registered across all major regulators. 10mg is the moderate-intensity primary-prevention starting dose, 20mg is the NHS first-line preferred dose for established cardiovascular disease, 40mg is high-intensity, and 80mg is high-intensity for the post-MI / post-stroke / homozygous FH evidence-base. All four supplied as scored or unscored film-coated tablets per market specification, in HDPE bottles or blister packaging in the buyer's destination language.
Is atorvastatin a controlled drug or schedule-restricted in any market?
No — atorvastatin 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. The 10mg strength is reclassified as Pharmacy-only (P) in the UK by MHRA from 2004 for over-the-counter sale in eligible primary-prevention adults, although in practice GP prescription dominates dispensing. No special transport, customs or destination-country licensing requirements beyond standard pharmaceutical import paperwork.
How does atorvastatin compare with rosuvastatin or simvastatin in tender pricing?
Atorvastatin and rosuvastatin are both high-intensity statins. Atorvastatin is typically priced lower per defined daily dose (DDD) at primary-care dispensing volumes due to longer off-patent maturity (atorvastatin lost patent 2011 globally; rosuvastatin 2016 in EU/US, later in some markets) and higher production scale among Indian manufacturers. Simvastatin is moderate-intensity only and is being progressively de-prescribed in NICE-aligned formularies. M Care can supply all three, but atorvastatin dominates tender volumes by approximately 10:1 over rosuvastatin and 4:1 over simvastatin in the UK NHS dispensing data. Rosuvastatin requires renal dose adjustment in CrCl <30, atorvastatin does not.
Are M Care's atorvastatin lines WHO Prequalified?
Multiple Indian generic atorvastatin manufacturers in M Care's partner network hold active WHO Prequalification status, opening Global Fund / UNFPA / GAVI pooled procurement at concessional pricing for low- and middle-income country donor programmes. 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 10mg and 20mg ship in 10-14 working days from PO ex-Mumbai. 40mg and 80mg high-intensity strengths typically 14-21 working days depending on partner manufacturer and current campaign. 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.
Can M Care provide a CTD Module 3 dossier for new-market registration?
Yes — full CTD Module 1-5 dossier preparation is part of M Care's standard workflow for new-market registrations. Module 3 quality data is partner-manufacturer-specific and reused across markets; Module 1 administrative content is country-specific and re-overlaid per destination regulator. Typical full-dossier preparation timeline is 30-45 working days from PO, plus 6-18 months for destination-regulator review (MHRA Decentralised Procedure, EMA MRP/DCP, SFDA, NAFDAC, etc.). Quote includes the dossier preparation fee separately from the per-tablet supply pricing.
Does atorvastatin need cold-chain shipping or special storage?
No cold-chain required. Atorvastatin film-coated tablets store at below 25°C in original blister or HDPE container, protect from moisture. 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.
Atorvastatin tablet — three-manufacturer-redundancy supply for the most-prescribed cardiovascular drug in the UK NHS, GCC and Africa.
Atorvastatin is everyday — global, generic, high-volume — and the buyer-side complexity is in the tender pack. 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.