Ranolazine Tablet
| Product/Composition:- | Ranolazine Tablet |
|---|---|
| Strength:- | 500mg |
| Form:- | Tablets |
| Production Capacity:- | 10 Million Tablets/Month |
| Packaging:- | 10 X 10 Tablets / Box |
| Therapeutic use:- | used to prevent chest pain |
| Package Insert/Leaflet:- | Available upon request |
Introduction
Ranolazine is an anti-anginal agent whose effect does not depend on reductions in heart rate or blood pressure.
As a modified-release product it carries a heavier regulatory burden than an immediate-release generic: no biowaiver route exists, and registration requires in-vivo bioequivalence under both fasting and fed conditions.
Complete CTD, ACTD and eCTD dossiers, CoPP, FSC and ICH Zone IVb stability are supplied for MOH registration.
Product Overview Table
| Field | Details |
| Product Name | Ranolazine Extended-Release Tablets |
| INN / Generic Name | Ranolazine |
| Therapeutic Class | Anti-anginal inhibitor of the late sodium current (late INa) |
| Mechanism (brief) | Inhibits the late inward sodium current in cardiac myocytes, reducing intracellular sodium and calcium overload. The anti-anginal effect does not depend on reductions in heart rate or blood pressure. |
| Indication | Chronic angina, per approved local labelling used with beta-blockers, calcium channel blockers or nitrates |
| Dosage Form Critical | Extended-Release tablet only. Swallow whole. Do Not crush, break or chew. |
| API Quality | Manufactured using DMF-grade Ranolazine |
| Pharmacopoeial Standard | USP Ranolazine Extended-Release Tablets USP |
| Available Strengths | 500 mg and 1000 mg extended-release tablets |
| Reference Regimen | 500 mg twice daily, increased to 1000 mg twice daily as required per approved labelling |
| BE Requirement | Two in-vivo studies fasting and fed. No biowaiver route exists for a modified-release product. |
| Cardiac Warning | Dose-dependent QT interval prolongation |
| Key Interactions | CYP3A substrate and P-glycoprotein inhibitor. Contraindicated with strong CYP3A inhibitors and strong CYP3A inducers; dose limits apply with moderate CYP3A inhibitors. |
| Hepatic | Contraindicated in liver cirrhosis, per reference labelling |
| Critical Quality Attribute | Integrity and reproducibility of the extended-release matrix. |
| Shelf Life | 36 Months |
| Storage | Store at 20–25°C; excursions permitted 15–30°C |
| Manufacturing Facility | WHO-GMP certified general oral solid dosage block with modified-release capability, segregated from beta-lactam operations |
| Dossier Available | Yes, CTD / ACTD / eCTD format |
Strengths & Presentation
Ranolazine Extended-Release Tablets 500 mg
The initiation strength and the one on which most patients begin therapy, taken twice daily.
It is also the strength most often used long term where the higher dose is not tolerated or not required.
In registration terms it occupies a useful position: where bioequivalence has been demonstrated on the higher strength, the 500 mg strength can generally be supported by comparison to the corresponding reference product rather than by a second pair of clinical studies.
Ranolazine Extended-Release Tablets 1000 mg
The maximum strength, used where the anti-anginal response at 500 mg twice daily is insufficient.
This is the strength on which bioequivalence studies are conducted, so it carries the registration weight for the range as well as the higher-dose clinical position.
Buyers generally tender both strengths together, since patients titrate between them.
What “Extended-Release” Means for This Product
No score line, and none should be added to artwork or tooling for any market
Twice-daily dosing is a property of the release profile, not a convenience choice the formulation is what delivers the dosing interval
Because the matrix controls exposure, dissolution profile comparison across multiple time points, not a single-point specification, is what demonstrates equivalence
Pharmacopoeial Compliance
USP: Ranolazine Extended-Release Tablets USP is the specification most widely requested for export
BP / Ph. Eur. / IP: confirm applicability to your SKU before claiming compliance
Regulatory & Dossier Support
Dossier Availability
CTD (Common Technical Document): ICH-aligned, for regulated and semi-regulated markets
ACTD (ASEAN Common Technical Dossier): Philippines, Vietnam, Myanmar, Indonesia, Cambodia
eCTD: for authorities mandating electronic submission
Module 3 quality documentation including the release-controlling excipient system, granulation and compression parameters, multi-point dissolution method validation and dose-dumping assessment
Stability data real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with dissolution profile monitored across shelf life rather than only at release
Country-specific dossier customisation and regulatory query response support included
Bioequivalence Two Studies, and No Way Around Them
Study 1 Fasting. Single-dose, two-treatment, two-period crossover, 1000 mg strength, ranolazine measured in plasma
Study 2 Fed. Same design and strength. For a modified-release product the fed study is not optional supporting data; food can alter the release profile, which is precisely what has to be shown not to happen
Subject selection carries a product-specific exclusion. Guidance specifically directs excluding subjects with risk factors for prolonged QT interval and Torsades de Pointes, because ranolazine prolongs the QT interval in a dose-dependent manner.
This is a protocol design point that inexperienced sponsors miss and that an ethics committee will raise
The 500 mg strength can generally be supported by comparison to the corresponding reference product rather than by a second pair of in-vivo studies, subject to the individual authority
Dose-dumping assurance is part of the package. Guidance addresses evidence that the drug is released as intended, to give assurance against premature release.
Drug Master File (DMF)
Drug Master File (DMF) reference for the Ranolazine API available for cross-referencing in your registration dossier
API sourced against a qualified vendor with impurity, residual solvent, polymorph and particle size characterisation
CDSCO / Indian DMF reference accepted by a large number of importing authorities
Manufacturing Compliance
WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis
Site Master File (SMF) available for regulatory submissions
Ranolazine is neither a beta-lactam nor a cytotoxic and is not subject to international drug control conventions, so no dedicated block is required.
Production runs in a general oral solid dosage block segregated from beta-lactam operations, with validated cleaning between products.
Modified-release manufacturing capability is the substantive question here.
Matrix-forming polymer grade and lot-to-lot consistency, granulation endpoint and compression force all influence the release profile, and they are controlled as process parameters rather than verified after the fact
Batch-level dissolution profile data at multiple time points, not a single-point release check
Compliant with the requirements of NAFDAC (Nigeria), PPB (Kenya), FDA Philippines, DRAP (Pakistan) and INVIMA (Colombia)
Complete Documentation Package (Per Shipment)
| Document | Purpose |
| Certificate of Analysis (CoA) | Confirms batch quality against the agreed specification |
| Certificate of Pharmaceutical Product (CoPP / CPP) | Required for MOH registration in most importing countries |
| Free Sale Certificate (FSC) | Confirms the product is freely sold in the country of manufacture |
| Method of Analysis (MOA) | Analytical methodology mandatory dossier component |
| GMP Certificate | Confirms manufacturing site compliance |
| Stability Data | Real-time and accelerated ICH Zone IVb, with dissolution profile across shelf life |
| BE Study Reports Fasting AND Fed | Both required for a modified-release product; states comparator and strength |
| Multi-Point Dissolution Profile | The performance parameter for an extended-release matrix |
| Dose-Dumping Assessment | Assurance against premature release of the full dose |
| Polymer / Excipient Grade Documentation | Release-controlling excipients specified by grade, not by name alone |
| Content Uniformity Data | Batch-level |
| Excipient Declarations | For all inactive ingredients |
Why the Release Matrix Is the Product
For an immediate-release tablet, an equivalent amount of the same active ingredient dissolving promptly will generally behave the same way.
For an extended-release tablet that is not true.
The rate at which the matrix releases drug over the dosing interval is the therapeutic property being sold, and it is produced by the polymer system, the granulation and the compression not by the active ingredient alone.
Two products with identical assay and identical actives can behave completely differently in a patient.
A failed matrix does not under-perform quietly, it dose-dumps. Premature release delivers the full dose at once, and on a molecule that prolongs the QT interval in a dose-dependent manner, that is a specific cardiac hazard rather than a general quality concern
This is why the swallow-whole instruction is a safety instruction. Crushing, breaking or chewing the tablet does mechanically what a failed matrix does chemically.
The instruction belongs on the carton face, not only in the leaflet
Release-controlling excipients are specified by grade and supplier, not by name.
A polymer of the same chemical description but a different viscosity grade produces a different release profile, and substituting one is a formulation change requiring regulatory variation not a purchasing decision
Dissolution is monitored across shelf life, because matrix behaviour can drift with storage in ways that assay will not reveal
A note for buyers evaluating low-cost alternatives: on immediate-release generics, price differences usually reflect margin.
On extended-release products they frequently reflect formulation development, and the cheapest matrix is often the one that has not been characterised across the pH range or across shelf life.
Ask any supplier for multi-point dissolution data over stability, not just a release CoA
Clinical Indications & Therapeutic Information
Ranolazine is an anti-anginal agent that inhibits the late inward sodium current in cardiac myocytes, reducing sodium-dependent calcium overload during ischaemia.
Its distinguishing clinical property is that the anti-anginal effect does not depend on reductions in heart rate or blood pressure, which is why it is positioned as an add-on where those parameters are already at target or cannot be lowered further.
Approved indication: chronic angina, per approved local labelling, used in combination with beta-blockers, calcium channel blockers or nitrates
QT prolongation is dose-dependent and shapes both prescribing and, the design of bioequivalence studies for this molecule
The interaction profile is dense and consequential. Ranolazine is a CYP3A substrate: reference labelling contraindicates concomitant use with strong CYP3A inhibitors and with strong CYP3A inducers, and imposes dose limits where moderate CYP3A inhibitors are co-prescribed.
It is also a P-glycoprotein inhibitor, which affects concomitant digoxin, and a dose limit applies to certain statins. This section of the leaflet must be reproduced in full for every market.
Reference labelling contraindicates use in liver cirrhosis, and caution applies in renal impairment both must carry through to local artwork
Swallow whole the tablet must not be crushed, broken or chewed. Patients unable to swallow whole tablets cannot use this product
Market structure: chronic angina remains prevalent across the markets this page targets, and ranolazine sits as an add-on rather than a first-line agent, so volumes are moderate and specialist-driven.
Because the registration burden is heavier than for an immediate-release generic, competition is thinner than the therapeutic area size would suggest which is the commercial opportunity on this molecule
Export Packaging & Supply Chain
Primary Packaging Options
| Presentation | Packaging Options |
| Ranolazine ER Tablets 500 mg | Alu-Alu blister 10×10, 6×10 and 3×10; HDPE bottle of 60 with induction seal and desiccant |
| Ranolazine ER Tablets 1000 mg | Alu-Alu blister 10×10 and 6×10; HDPE bottle of 60 |
| Chronic-therapy packs | 28-day or 60-tablet configurations aligned to twice-daily dosing |
Twice-daily dosing means a 60-tablet pack maps cleanly to one month of therapy, which is worth specifying rather than defaulting to a 100-count container.
Alu-Alu is recommended for Zone IVb markets: an extended-release matrix that takes up moisture over a long shelf life can change its release behaviour, and that is a failure mode assay testing will not detect.
Why Source Ranolazine ER Tablets From Us?
Both Bioequivalence Studies Held: Fasting and fed, as product-specific guidance requires for a modified-release product. There is no biowaiver route on this molecule, and a supplier offering one has misread the guidance.
Modified-Release Manufacturing Capability, Documented: Polymer grade and lot consistency, granulation endpoint and compression force controlled as process parameters, with multi-point dissolution data at batch level rather than a single-point release check.
Dissolution Monitored Across Shelf Life: Matrix behaviour can drift with storage in ways assay will never reveal. We track the release profile through stability, not only at release.
Dose-Dumping Assurance in the Package: A failed extended-release matrix delivers the full dose at once, and ranolazine prolongs the QT interval in a dose-dependent manner. That makes release control a safety control.
Artwork That Prevents Substitution Errors: “Extended-Release” carried in the product name on carton and foil, with no score line anywhere in the design.
WHO-GMP Certified Manufacturing: Segregated general oral solid facility with modified-release capability. GMP certificate and Site Master File (SMF) shared on request.
Frequently Asked Questions
Q1. Do you provide a dossier for Ranolazine Extended-Release Tablets?
Yes. We provide complete dossiers in CTD, ACTD and eCTD formats for both strengths.
The dossier includes Module 3 quality documentation covering the release-controlling excipient system, granulation and compression parameters, multi-point dissolution method validation, dose-dumping assessment, ICH Zone IVb stability with dissolution tracked across shelf life, and both bioequivalence study reports.
Q2. How many bioequivalence studies does this product require?
Two. Product-specific guidance for ranolazine extended-release tablets recommends two in-vivo studies with pharmacokinetic endpoints one fasting and one fed both single-dose, two-treatment, two-period crossover designs on the 1000 mg strength, measuring ranolazine in plasma.
There is no biowaiver route for a modified-release product, and any supplier suggesting otherwise has not read the guidance.
Q3. Does the recent move to a single bioequivalence study apply here?
No. That reform applies to immediate-release oral solid dosage forms where the risk of a food effect is not high.
Modified-release products are outside its scope, and ranolazine remains a two-study molecule.
This comes up often enough that it is worth confirming with your regulatory team before budgeting.
Q4. Do we need separate studies for the 500 mg strength?
Generally not. Where bioequivalence is demonstrated on the 1000 mg strength, the 500 mg strength can usually be supported by comparison to the corresponding reference product rather than by a second pair of in-vivo studies.
This remains subject to the individual authority, so confirm it for your market before planning the submission.
Q5. Why does the bioequivalence protocol exclude certain subjects?
Because ranolazine prolongs the QT interval in a dose-dependent manner.
Product-specific guidance directs that subjects with risk factors for prolonged QT interval and Torsades de Pointes be excluded from the studies.
It is a protocol design point that inexperienced sponsors miss and that an ethics committee will raise.
Q6. Can the tablet be crushed or given through a feeding tube?
No. The tablet must be swallowed whole and must not be crushed, broken or chewed.
Breaking the matrix mechanically does what a failed matrix does chemically it releases the full dose at once, on a molecule with dose-dependent QT prolongation.
A patient unable to swallow whole tablets cannot use this product.
Q7. Can you supply under our private label?
Yes, with two firm exceptions beyond the usual safety-labelling constraint.
“Extended-Release” must appear in the product name on every carton face and on the blister foil, because a pack reading simply “Ranolazine Tablets” invites a dispensing error.
And no score line may be added to the tablet or shown in artwork, regardless of brand consistency across your range.
Q8. What should we ask a supplier when comparing quotations?
Ask for multi-point dissolution data across stability, not just a release CoA, and ask whether both fasting and fed studies are held and against which comparator.
On immediate-release generics a price difference usually reflects margin. On extended-release products it frequently reflects how thoroughly the release matrix has been characterised.
Ready to Source Ranolazine Extended-Release Tablets FDF?
Share your target market and expected annual volume, and our export team will confirm whether our existing fasting and fed bioequivalence package is acceptable to that authority or whether local comparator studies are needed, along with specification, dossier format, pack options and pricing.
If you are at technical evaluation stage, request the multi-point dissolution data across stability and a sample CoA.