Introduction

Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Nimodipine Tablets 30 mg as a finished dosage formulation not API to importers, hospital procurement and neurosurgical units across Africa, Southeast Asia, Latin America and the Middle East.

Nimodipine is a cerebroselective dihydropyridine calcium channel blocker used to improve neurological outcome following aneurysmal subarachnoid haemorrhage.

It is an enteral-only medicine: it must never be given intravenously, and our labelling and pack design are built around that restriction rather than merely disclosing it.

Complete CTD, ACTD and eCTD dossiers, in-vivo bioequivalence data, CoPP, FSC and ICH Zone IVb stability are supplied for MOH registration.

Product Overview Table

Field	Details
Product Name	Nimodipine Tablets
INN / Generic Name	Nimodipine
Therapeutic Class	Cerebroselective dihydropyridine calcium channel blocker
Mechanism (brief)	Mechanism of clinical benefit in subarachnoid haemorrhage is not fully elucidated. Nimodipine dilates blood vessels and prevents vasoconstriction in small arterioles of roughly 70-100 µm diameter.
Indication	Improvement of neurological outcome by reducing the incidence and severity of ischaemic deficits in patients with subarachnoid haemorrhage from ruptured intracranial aneurysm per approved local labelling
Route Critical	Enteral Only oral, nasogastric tube or gastric tube. Never intravenous or any other parenteral route.
Boxed Warning	Death due to inadvertent intravenous administration. IV administration of capsule contents has caused death, cardiac arrest, cardiovascular collapse, hypotension and bradycardia.
API Quality	Manufactured using DMF-grade Nimodipine
Pharmacopoeial Standard	BP / USP
Available Strength	30 mg film-coated tablets
Reference Regimen	60 mg (two 30 mg tablets) every 4 hours for 21 consecutive days, commenced within 96 hours of SAH onset
Course Quantity	Approximately 252 tablets per patient course see Section 8, this drives pack design
Food Effect	Administer at least 1 hour before or 2 hours after meals
Key Interactions	CYP3A4 substrate. Grapefruit juice to be avoided. Strong CYP3A4 inhibitors and inducers require specific management per labelling.
Biopharmaceutics	Poorly water-soluble with low and variable oral bioavailability from extensive first-pass metabolism a Class II profile, no biowaiver
Storage	Tablets: protect from moisture and light
Shelf Life	36 Months
Manufacturing Facility	WHO-GMP certified general oral solid dosage block, segregated from beta-lactam operations
Dossier Available	Yes, CTD / ACTD / eCTD format

Presentation & the Dosage Form Argument

Nimodipine Tablets 30 mg

The single strength, film-coated, supplied for the reference regimen of 60 mg two tablets every four hours for twenty-one consecutive days, beginning as soon as possible and within 96 hours of the onset of subarachnoid haemorrhage.

Because dosing runs around the clock for three weeks, consumption per patient is both large and highly predictable, which makes this an unusually forecastable hospital line item.

Why the Tablet Presentation Matters Stated Honestly

The boxed warning on this molecule arose principally from the liquid-filled capsule presentation.

Where a patient cannot swallow which in subarachnoid haemorrhage is common the capsule labelling directs that a hole be made in both ends of the capsule with a needle and the contents extracted into a syringe for administration through a nasogastric tube.

That procedure produces a syringe of clear liquid at a bedside surrounded by intravenous lines, and it is from precisely that situation that fatal intravenous administrations have occurred.

We recommend buyers confirm their units stock these before the first order.

Specification & Testing

Assay, content uniformity, dissolution and related substances against the declared monograph

Discriminatory dissolution method validated across the physiological pH range the governing performance parameter for a poorly soluble molecule

Photostability data supporting the light-protection storage statement

Moisture control across shelf life, supporting the packing specified in Section 8

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 process validation, dissolution method validation, content uniformity and photostability

Stability data: real-time and accelerated under ICH Zone IVb (30°C / 75% RH), with photostability supporting the light-protection statement

Module 1 labelling built around the enteral-only restriction and the boxed warning

Bioequivalence: No Biowaiver, and a Study That Needs Care

Nimodipine is poorly water-soluble and undergoes extensive first-pass metabolism, giving low oral bioavailability.

That profile places it outside the BCS-based biowaiver route, so in-vivo bioequivalence (BE) data against the reference product is required for market authorisation in effectively every jurisdiction.

Because dissolution is the rate-limiting step for absorption, the dissolution method must be genuinely discriminatory rather than merely compliant.

Low and variable bioavailability has a study-design consequence.

High within-subject variability increases the sample size needed to demonstrate bioequivalence with adequate power, and a replicate design may be worth considering.

A study sized as if this were an ordinary immediate-release generic is the most common way applicants fail on this molecule

Food effect matters to the study, not only to the label. Reference labelling directs administration at least one hour before or two hours after meals, so the fed or fasted condition of the BE study must match the labelled condition

Comparative dissolution profiles across the physiological pH range held throughout shelf life

Drug Master File (DMF)

Drug Master File (DMF) reference for the Nimodipine API available for cross-referencing in your registration dossier

API sourced against a qualified vendor with impurity, residual solvent, polymorph and particle size characterisation particle size matters here, as on any poorly soluble molecule

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

Nimodipine 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 physically segregated from beta-lactam operations, with validated cleaning between products.

Light-protected handling and storage through manufacture and packing, consistent with the photostability profile

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, plus photostability
BE Study Report	In-vivo bioequivalence not waivable for this molecule; states design and fed/fasted condition
Dissolution Profile Report	Discriminatory method the governing performance parameter
Content Uniformity Data	Batch-level
Enteral-Only Administration Guidance	For destination pharmacy and nursing supplied with the consignment, see Section 5F
Excipient Declarations	For all inactive ingredients

Route-Error Prevention What We Supply Beyond the Product

Artwork carries the enteral-only restriction prominently on the outer carton, not only in the leaflet, because route errors happen at the bedside where the leaflet is not present

“For enteral use only not for injection” appears on the blister foil, so the restriction survives the carton being discarded partway through a 21-day course. This is a small design decision with a disproportionate effect

Administration guidance supplied with each consignment in the destination language, covering nasogastric administration, the requirement for enteral-only syringes and connectors, and the instruction to store and label oral nimodipine separately from intravenous medicines

The separation instruction reflects established practice rather than our own preference reference practice is explicit that oral nimodipine should be labelled and kept separate specifically to avoid its administration intravenously

We raise enteral connector availability at the enquiry stage.

A unit without enteral-specific syringes is not equipped to run this product safely, and it is better for both parties to establish that before the first order rather than after an incident

Course-oriented pack options reduce loose-tablet handling across a 21-day regimen.

Clinical Indications & Therapeutic Information

Nimodipine is a dihydropyridine calcium channel blocker with a high degree of cerebroselectivity.

Reference labelling states that the mechanism of clinical benefit in subarachnoid haemorrhage has not been fully elucidated; nimodipine dilates blood vessels and prevents vasoconstriction in small arterioles of approximately 70 to 100 µm in diameter, and it is not established whether it prevents or relieves cerebral artery vasospasm.

Approved indication: improvement of neurological outcome by reducing the incidence and severity of ischaemic deficits in patients with subarachnoid haemorrhage from ruptured intracranial aneurysm, per approved local labelling

Boxed warning death due to inadvertent intravenous administration. Intravenous administration of nimodipine capsule contents has resulted in death, cardiac arrest, cardiovascular collapse, hypotension and bradycardia.

Administration is by the enteral route only. This warning must carry through to leaflet and artwork in full.

The reference regimen begins as soon as possible and within 96 hours of SAH onset, and runs at 60 mg every four hours for 21 consecutive days a fixed, protocol-driven course rather than a titrated therapy

Administration is at least one hour before or two hours after meals, and grapefruit juice is to be avoided; nimodipine is metabolised by CYP3A4, and strong inhibitors and inducers require specific management per labelling

If nimodipine is inadvertently given intravenously, reference labelling notes that clinically significant hypotension may require cardiovascular support with pressor agents, and that specific treatment for calcium channel blocker overdose should be given promptly.

This belongs in the leaflet in full it is the instruction a unit will need at the worst possible moment

Market structure: a hospital product used in a narrow, severe indication, so volumes track neurosurgical and stroke-unit capacity rather than population.

But because each patient consumes a fixed 21-day course, per-patient demand is exact and forecasting is unusually reliable once case volumes are known

Target Export Markets

Africa

Candidate markets: Egypt, Nigeria, Kenya, Ghana, Ethiopia, South Africa, Tanzania

Registration support: NAFDAC (Nigeria), PPB (Kenya), FDA Ghana, TFDA (Tanzania) CoPP and FSC are the primary gatekeeping documents

Demand concentrates in tertiary referral and teaching hospitals rather than in general distribution

Labelling: English and French artwork available for Anglophone and Francophone Africa

Southeast Asia

Candidate markets: Philippines, Vietnam, Thailand, Indonesia, Malaysia, Bangladesh

ACTD dossier format supplied as standard mandatory for ASEAN registrations

Stability: ICH Zone IVb data plus moisture and light protective packing is a prerequisite

Latin America (LATAM)

Candidate markets: Colombia, Peru, Ecuador, Dominican Republic, Guatemala

USP or BP standard per authority; Spanish and Portuguese labelling available

CTD format with local regulatory adaptation, legalisation and apostille support

Middle East & CIS

Candidate markets: Iraq, Jordan, Gulf states, Uzbekistan, Kazakhstan, Azerbaijan

GMP Certificate and CoPP are the primary registration requirements across these authorities

Arabic and Russian labelling available, including the enteral-only administration guidance

Export Packaging & Supply Chain

Pack Design Is Driven by the Regimen

The reference regimen is 60 mg every four hours for 21 consecutive days.

That is six doses a day, two tablets per dose, for three weeks approximately 252 tablets for a single patient course.

Pack configuration therefore has real operational consequences: a hospital pharmacy dispensing that quantity from bulk containers, six times daily across three weeks, is handling loose tablets hundreds of times for one patient.

Course-oriented packs reduce that handling and make it far easier to see at a glance whether a dose has been missed.

Presentation	Packaging Options
Nimodipine Tablets 30 mg standard	Alu-Alu blister 10×10 and 3×10, light and moisture protective, in mono-carton with leaflet
Course pack	21-day course configuration aligned to the reference regimen, reducing loose-tablet handling
Hospital / ICU pack	Unit-dose blister with enteral-only wording on the foil, for ward-level stock
Tender / Programme Supply	Bulk shipper configurations with programme overprinting

Alu-Alu is specified rather than offered as an upgrade, because tablet labelling directs protection from both moisture and light.

Foil-level messaging matters more here than on almost any other product in this portfolio: a 21-day course means the outer carton is often discarded early, and the blister is what remains at the bedside for the following three weeks.

Labelling & Customisation

Private label manufacturing with your brand name and artwork, subject to unchanged regulatory content

Multi-lingual labelling: English, French, Spanish, Portuguese, Arabic, Russian

Mandatory artwork content: the boxed warning, the enteral-only route restriction on carton and foil, the food-timing instruction, grapefruit avoidance, the CYP3A4 interaction caution, storage statement and country-specific registration fields

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW as per buyer requirement

No cold chain required; protect from moisture, light and sustained heat in transit

Lead time: Subarachnoid haemorrhage is an emergency presentation and treatment must begin within 96 hours, so a unit that runs out cannot wait for resupply.

We advise buyers to hold buffer stock sized to their case volume rather than ordering against consumption, and we plan against committed annual forecasts

Why Source Nimodipine Tablets From Us?

A Tablet, Not a Liquid-Filled Capsule: The documented fatal error pathway on this molecule involves extracting capsule liquid into a syringe at an ICU bedside. The tablet removes that step. It does not remove the need for enteral-only discipline, and we say so plainly rather than overselling it.

Enteral-Only Wording on the Foil, Not Just the Carton: Across a 21-day course the carton is usually gone within days. The blister is what remains at the bedside, so that is where the route restriction belongs.

Route-Error Prevention Support: Administration guidance in the destination language covering nasogastric use, enteral-only syringes and the instruction to store oral nimodipine separately from intravenous medicines. We raise enteral connector availability before the first order.

BE Study Designed for a Variable Molecule: Nimodipine is poorly soluble with low, variable bioavailability, and a study sized like an ordinary generic fails. We advise on design and fed/fasted condition before your data package is built.

Course-Oriented Pack Options: Roughly 252 tablets per patient course. Pack design that reflects the regimen reduces handling and makes missed doses visible.

Complete Dossier in CTD, ACTD and eCTD: Pre-compiled with regulatory query response support, and WHO-GMP certified manufacturing with Site Master File (SMF) shared on request.

Frequently Asked Questions

Ready to Source Nimodipine Tablets FDF?

Share your target market and expected annual case volume, and our export team will respond with the applicable specification, dossier format, pack options including course configurations, buffer stock guidance and pricing.

If you are at technical evaluation stage, request the bioequivalence study abstract, dissolution and photostability summaries, and a sample CoA.