Rosuvastatin Calcium Tablets 5, 10, 20 and 40mg from India
Rosuvastatin calcium film-coated tablets in 5mg, 10mg, 20mg and 40mg, supplied from WHO-GMP and EU-GMP partner sites in India. M Care Exports books NHS Category M generic volumes, GCC central tender lots and African MoH lipid-management programmes against CTD-ready dossiers, full CoA, GDP cold-chain logistics and a 4 to 6 week lead time on validated SKUs.
Rosuvastatin 5/10/20/40mg supply file
Active ingredient
Rosuvastatin calcium, INN rosuvastatin, ATC C10AA07. CAS 147098-20-2 for the calcium salt, 287714-41-4 for the free acid. HMG-CoA reductase inhibitor, hydrophilic relative to atorvastatin, primarily renal excretion of unchanged drug with limited CYP2C9 metabolism.
Strengths stocked
5mg, 10mg, 20mg and 40mg film-coated tablets, dose expressed as rosuvastatin base. Standard pack: 10x10 alu-PVC blister cartons, 30s HDPE bottles for tender markets, 90s hospital packs on request. Stability 24 to 36 months at below 30 degrees Celsius.
Indications scope
Primary and mixed dyslipidaemia, heterozygous and homozygous familial hypercholesterolaemia, primary and secondary cardiovascular event prevention, and slowing progression of atherosclerosis as an adjunct to diet, per the partner-site SmPC and NICE NG181 positioning.
Buyer fit
NHS Category M Drug Tariff procurement, GCC central tender desks (NUPCO, IDA Kuwait, MOPH Qatar), African MoH and NGO non-communicable disease programmes, EU and LATAM private importers running national-formulary generic statin lines.
What we file
CTD Module 1 country-specific shells, Module 2 quality and clinical summaries, Module 3 quality data, batch CoA, dissolution profiles, BE study reports where mandated, GMP certificates and CPP from CDSCO India.
Lead times
Validated SKUs: 4 to 6 weeks ex-works Mumbai or Ahmedabad. New strength validation or unique pack: 8 to 12 weeks including stability pulls. Lead time confirmed in the pro-forma after stock check at the partner site.
Rosuvastatin tender and contract supply by region
Off-patent since 2016 globally, rosuvastatin sits in the high-volume generic statin tier. M Care Exports books partner-site capacity against contracted volumes for the four buyer groups below.
UK NHS
NHS Drug Tariff Category M generic. Volumes booked against published reimbursement prices, MHRA-registered partner site, GDP-compliant onward shipment to UK wholesaler hubs. Suitable for primary-care prescription lines and hospital trust formulary slots.
GCC
Saudi NUPCO, IDA Kuwait, MOPH Qatar, MoHAP UAE and Bahrain Health Authority central tenders. Arabic-English dual labelling, GCC dossier in eCTD with stability data at Zone IVa and IVb storage conditions, halal manufacturing declaration available.
African
Ministry of Health and NGO statin programmes across Nigeria, Kenya, Ghana, Ethiopia, Tanzania, Uganda, South Africa, Anglophone West Africa and SADC. CDSCO India CPP, WHO PQ partner status where applicable, country-specific labelling and pack sizes on request.
EU/LATAM/SEA
Private importers in Germany, France, Spain, Portugal, Brazil, Mexico, Colombia, Vietnam, the Philippines and Indonesia. EU-GMP partner site, CEP from EDQM for selected APIs, eCTD dossier and EU-compliant artwork files.
Pharmacology, interactions and procurement considerations
Rosuvastatin is a selective inhibitor of HMG-CoA reductase, the rate-limiting step in hepatic cholesterol synthesis. Compared to atorvastatin and simvastatin, it is relatively hydrophilic and reaches hepatocytes largely through the OATP1B1 organic-anion transporter rather than passive diffusion. Metabolism is limited: only around 10 percent of the absorbed dose is converted to the N-desmethyl metabolite via CYP2C9, and CYP3A4 contributes negligibly. Approximately 90 percent of the drug that enters systemic circulation is excreted unchanged, mostly in faeces via biliary clearance. This profile reduces the clinical relevance of strong CYP3A4 inhibitors such as clarithromycin, itraconazole and ritonavir compared with atorvastatin and simvastatin, but raises the importance of OATP1B1 inhibitors. Ciclosporin substantially increases rosuvastatin exposure and is generally avoided. Gemfibrozil and certain HIV protease inhibitor combinations require dose capping. Coumarin anticoagulant INR should be rechecked when rosuvastatin is started, stopped or dose-adjusted. The 40mg strength is reserved for patients with severe primary hypercholesterolaemia and high cardiovascular risk who have not reached treatment targets on 20mg and is contraindicated in severe renal impairment (estimated GFR below 30 mL/min/1.73m2), pre-existing myopathy or concomitant ciclosporin. Asian ethnicity is associated with approximately twofold higher exposure relative to Caucasian populations, and the originator label and most ICH-region SmPCs recommend that 5mg be considered as the starting dose for Asian patients, with 40mg avoided. NICE NG181 (2023) lists rosuvastatin alongside atorvastatin as appropriate primary and secondary prevention statins, with atorvastatin 20mg the NICE-preferred first-line option and rosuvastatin commonly used where atorvastatin is not tolerated or where interaction with strong CYP3A4 inhibitors is a concern. The WHO 23rd Model List of Essential Medicines (2023) includes rosuvastatin in the cardiovascular section as a representative HMG-CoA reductase inhibitor. For procurement, the four points buyers most often query are: confirmed strength of the calcium salt expressed as base, BE study coverage for the specific dose strengths required by the destination regulator, primary packaging stability at Zone IVa or IVb where applicable, and Asian-population dosing language on artwork for markets with a significant East Asian population. M Care Exports works against partner-site CTD dossiers in which each of these is pre-addressed.
Approvals, dossiers and pharmacovigilance
Rosuvastatin is off-patent in all major ICH and African markets since 2016. M Care Exports works with partner sites whose dossiers map directly to the regulatory frameworks below.
WHO EML
Rosuvastatin is named on the 23rd WHO Model List of Essential Medicines (2023) within the cardiovascular section as a representative HMG-CoA reductase inhibitor. The listing supports inclusion in national essential-medicines lists and donor-funded NCD procurement.
MHRA
Generic rosuvastatin holds UK marketing authorisations granted by the MHRA under the abridged generic route. NHS Drug Tariff Category M reimbursement applies. Partner sites supply against MHRA-recognised GMP certification and UKNI or GB packs as required.
EMA
Generic rosuvastatin is authorised across EU member states via decentralised and national procedures. EU-GMP partner sites supply against eCTD Module 1 country-specific shells, Module 2 summaries, Module 3 quality data and EU-compliant artwork with QRD template compliance.
GCC
Saudi SFDA, UAE MoHAP, Kuwait MoH, Qatar MoPH, Bahrain NHRA and Oman MoH register rosuvastatin through GCC-DR harmonised review or national routes. M Care Exports prepares Arabic-English dual artwork, Zone IVa or IVb stability data and halal manufacturing declarations.
African
Nigeria NAFDAC, Kenya PPB, Ghana FDA, Ethiopia EFDA, Tanzania TMDA, Uganda NDA and South Africa SAHPRA accept CDSCO India CPP plus dossier. NAFDAC re-registration cycle is five years and routinely requires updated BE evidence at full strength range.
Pharmacovigilance
Partner-site PSUR cycle aligned with EU PSUR Single Assessment where applicable, national PV agreements for GCC and African markets, local QPPV nominated for EU consignments, ICSR reporting routed via partner site PV cell to importer of record.
Cardiovascular molecules and services to bundle
Tender desks rarely book a statin in isolation. The pages below cover the molecules and dossier services M Care Exports most often quotes alongside rosuvastatin.
Atorvastatin
The other primary-prevention statin named in NICE NG181 and the more commonly listed statin on prior WHO EML editions. Different CYP profile, often substituted where rosuvastatin is intolerable.
Amlodipine
Long-acting calcium channel blocker for hypertension. Routinely co-prescribed with a statin under WHO HEARTS and NICE NG136 cardiovascular protocols.
Losartan
Angiotensin II receptor blocker for hypertension, diabetic nephropathy and heart failure. Common second pillar of the cardiovascular tender basket alongside a statin.
Metoprolol
Beta-1 selective blocker for ischaemic heart disease, post-MI, arrhythmia and heart failure with reduced ejection fraction. Frequently bundled with rosuvastatin in secondary-prevention tenders.
GCC tender response
Dedicated dossier service for NUPCO, IDA Kuwait, MOPH Qatar, MoHAP UAE and Bahrain NHRA tenders. Arabic-English artwork, Zone IVa or IVb stability, halal declarations and ASCC labelling.
EU-GMP import
EU-GMP partner-site sourcing, eCTD dossier preparation, EU QPPV nomination and importer-of-record liaison for German, French, Spanish and Portuguese generic statin lines.
From RFQ to delivered rosuvastatin lot
- RFQ and shortlist. Buyer sends strengths, pack sizes, destination market, target dossier (MHRA, EMA, GCC, African MoH) and annual volume. M Care Exports shortlists 2 to 3 WHO-GMP or EU-GMP partner sites with current registrations or eligibility for the destination.
- Dossier review. Partner-site CTD modules, CDSCO CPP, GMP certificate, BE study coverage and pack-format specifications are shared under NDA. Buyer regulatory affairs team reviews fit against destination requirements and flags any gap.
- Pro-forma and lock. Pro-forma invoice issued with confirmed EXW price per pack, validated lead time, payment terms (LC at sight, TT advance or open account by market) and Incoterms. Buyer locks order with deposit and PO.
- Production and release. Partner site schedules the campaign, runs in-process QC, completes finished-product testing per pharmacopoeial monograph and issues CoA. Partner-site QA releases each batch with stability pull data referenced.
- Shipment and PV setup. M Care Exports books the freight (sea LCL or FCL, air for trial lots or urgent tender slots), prepares export documentation, dispatches against the agreed Incoterms and confirms pharmacovigilance routing with the importer of record.
Rosuvastatin buyer FAQ
How does rosuvastatin differ from atorvastatin for tender purposes?
Both are recognised by NICE NG181 and listed by major regulators as primary and secondary prevention statins. Rosuvastatin is relatively hydrophilic, mainly renally excreted as unchanged drug and only minimally metabolised by CYP3A4 (mostly CYP2C9). Atorvastatin is more lipophilic and CYP3A4-metabolised, which makes it more sensitive to macrolide and azole interactions. NICE positions atorvastatin 20mg as first-line for primary prevention; rosuvastatin is the common substitute. For tenders, buyers often dual-source both molecules to cover the full primary-prevention statin volume and account for tolerance switching.
What strengths and pack formats do you supply, and are they expressed as base or salt?
We supply 5mg, 10mg, 20mg and 40mg film-coated tablets, with dose strength expressed as rosuvastatin base, not the calcium salt. Standard primary packaging is alu-PVC blister in 10x10 cartons. HDPE bottles in 30s are common for GCC and African tenders. Hospital 90s packs and unit-dose strips are available on request. Stability is supported to 24 to 36 months at below 30 degrees Celsius in the validated pack, with Zone IVa or IVb stability data available for tropical-market submissions.
Is rosuvastatin on the WHO Model List of Essential Medicines?
Rosuvastatin is included on the 23rd WHO Model List of Essential Medicines (2023) within the cardiovascular section as a representative HMG-CoA reductase inhibitor. Atorvastatin has historically been the more commonly listed statin on earlier WHO EML editions, and many national essential-medicines lists name both. For donor-funded NCD programmes, M Care Exports confirms partner-site WHO Prequalification status and CDSCO India CPP coverage at the dossier-review stage of every RFQ.
Why do some markets require Asian-population dosing language on the artwork?
Population pharmacokinetic data show that systemic exposure to rosuvastatin is approximately twofold higher in Asian patients (Chinese, Japanese, Korean, Filipino, Vietnamese, South Asian) than in matched Caucasian patients on the same dose. The originator label and most ICH-region SmPCs recommend that 5mg be considered as the starting dose for Asian patients, and 40mg is avoided in this population. Markets with a significant East Asian population, including the GCC expatriate population, often require this dosing caveat on the patient information leaflet and SmPC. Partner-site artwork files include the relevant language.
How does NHS Drug Tariff Category M apply to rosuvastatin?
Rosuvastatin is a Drug Tariff Category M generic, meaning its NHS reimbursement price is set monthly by NHS Business Services Authority based on manufacturer survey data, not by community-pharmacy purchase price. For exporters into the UK, Category M imposes tight commercial discipline: pricing is benchmarked against the published Tariff, and partner-site cost structure must support the reimbursement envelope on volumes that can run into tens of millions of tablets per year. M Care Exports books NHS Category M volumes against MHRA-registered partner sites with GDP-compliant onward logistics to UK wholesaler hubs.
Which regulatory pathways do you typically support for rosuvastatin?
We file CTD or eCTD dossiers for MHRA in the UK (abridged generic route), EMA member states via national or decentralised procedures, GCC central registration through SFDA, MoHAP, MoH Kuwait, MoPH Qatar, NHRA Bahrain and MoH Oman, and African national MoH bodies including NAFDAC, PPB, Ghana FDA, EFDA, TMDA, NDA and SAHPRA. CDSCO India issues the CPP. Partner-site GMP status is MHRA, EU-GMP or WHO-GMP depending on the destination, and ANVISA Brazil or COFEPRIS Mexico submissions are filed where the buyer requires.
What lead time and minimum order quantity should I plan for?
For validated SKUs (strength, pack format and artwork already on the partner-site CTD), expect 4 to 6 weeks ex-works Mumbai or Ahmedabad. A new strength validation, a new pack format or a new country artwork file adds 8 to 12 weeks for additional stability pulls and analytical method bridging. Indicative minimum order quantity is 500,000 tablets per strength for blister packs and 100,000 bottles for 30s HDPE bottles, with lower volumes negotiable for first orders in NGO and pilot tender slots. The pro-forma confirms MOQ, lead time and EXW price after stock check.
Quote a rosuvastatin lot
Share strengths, pack format, destination market and target dossier and annual volume. We come back with shortlisted partner sites, indicative EXW pricing and confirmed lead time inside one working day.