Isosorbide Mononitrate Lyophilized Injection
| Product/Composition:- | Isosorbide Mononitrate Lyophilized Injection |
|---|---|
| Strength:- | 25mg, 50mg |
| Form:- | Lyophilized Injection |
| Production Capacity:- | 1 Million Lyophilized Injection/Month |
| Therapeutic use:- | Cardiovascular |
| Package Insert/Leaflet:- | Available upon request |
Introduction
We are a WHO-GMP-certified pharmaceutical exporter supplying Isosorbide Mononitrate Lyophilized Injection finished-dosage formulations to importers and distributors across Africa, Southeast Asia, the Middle East & CIS.
Isosorbide Mononitrate, a well-established nitrate vasodilator, is manufactured by us as a sterile lyophilized powder for injection, reconstituted for intravenous administration in the acute management of angina pectoris and related cardiac conditions.
Each batch is formulated for consistent potency, rapid reconstitution, and stability under tropical storage conditions, supporting reliable clinical performance and patient compliance in hospital settings.
Every shipment is backed by a complete regulatory dossier, enabling fast-track market authorization and MOH registration in your country.
Product Overview Table
| Field | Details |
| Product Name | Isosorbide Mononitrate Lyophilized Injection |
| INN / Generic Name | Isosorbide Mononitrate |
| Therapeutic Class | Nitrate Vasodilator / Anti-Anginal Agent |
| Indications | Angina Pectoris (acute & prophylactic management); adjunct in acute left ventricular failure |
| API Quality | Manufactured using DMF-grade Isosorbide Mononitrate |
| Pharmacopoeial Standard | BP / USP / IP (confirm applicable standard per buyer requirement) |
| Available Strengths | 1 mg/mL e.g. 10 mg/10 mL, 50 mg/50 mL vial |
| Dosage Form | Lyophilized Powder for Injection (for IV infusion after reconstitution) |
| Shelf Life | 24 – 36 Months |
| Storage | Store below 25°C, protect from light; do not freeze |
| Manufacturing Facility | WHO-GMP Certified Facility dedicated sterile/lyophilized injectable manufacturing line |
| Dossier Available | Yes, CTD / ACTD / eCTD format |
| Regulatory Documents | CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data |
| Markets Served | Africa, Southeast Asia, Latin America, Middle East & CIS |
Product Variant, Dosage Form & Strength
Isosorbide Mononitrate Lyophilized Injection (1 mg/mL)
Sterile lyophilized powder for injection, reconstituted for intravenous infusion in acute and hospital-based cardiac care
Key markets: Africa, Middle East, CIS, and Southeast Asian hospital and institutional procurement channels
Keyword target: Isosorbide Mononitrate injection exporter, Isosorbide Mononitrate lyophilized powder for injection supplier
Pharmacopoeial Compliance
Regulatory & Dossier Support
Dossier Availability
CTD (Common Technical Document) – ICH-aligned and most regulated markets
ACTD (ASEAN Common Technical Dossier) – Philippines, Vietnam, Myanmar, Indonesia, Cambodia
eCTD (Electronic CTD) – for markets requiring electronic submissions
Country-specific dossier customization available on request
Dossier includes: Quality Module (Module 3) and Safety & Efficacy summaries, as applicable.
Bioavailability & Comparative Performance
As an intravenous formulation, Isosorbide Mononitrate Lyophilized Injection is designed to achieve complete bioavailability.
Comparative pharmacokinetic and stability data available on request to support regulated-market dossier submissions
Drug Master File (DMF)
API Drug Master File (DMF) reference available for cross-referencing in the buyer’s regulatory dossier
Helps reduce registration timelines in the importing country
CDSCO / Indian DMF available – reference acceptable for many markets
Manufacturing Compliance
WHO-GMP certified manufacturing facility
Site Master File (SMF) available for regulatory submissions
Facility audit-ready; inspection reports available on NDA basis
Dedicated sterile lyophilization/injectable manufacturing suite compliant with aseptic processing guidelines – ensures sterility and particulate-free reconstitution.
Compliant with: NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania).
Complete Documentation Package (Per Shipment)
| Document | Purpose |
| Certificate of Analysis (CoA) | Confirms product quality against specifications |
| Certificate of Pharmaceutical Product (CoPP / CPP) | Required for MOH registration in most countries |
| Free Sale Certificate (FSC) | Confirms product is freely sold in country of manufacture |
| Method of Analysis (MOA) | Lab testing methodology — required for dossier |
| GMP Certificate | Confirms manufacturing facility compliance |
| Stability Data | Real-time and accelerated — ICH Zone IVb for tropical markets |
| Batch Manufacturing Records (BMR) | Available on request (NDA basis) |
| Excipient Declarations | For all inactive ingredients used |
Clinical Indications & Therapeutic Information
Isosorbide Mononitrate Lyophilized Injection is a long-acting nitrate vasodilator used in the management of angina pectoris
Key indications: prophylaxis and treatment of angina pectoris; adjunct therapy in chronic heart failure
Dosage varies based on clinical presentation, cardiac function, and physician-guided titration – prescriber-guided
Manufactured in a dedicated sterile injectable facility, ensuring a particulate-free, pyrogen-free formulation – a critical safety point for regulated-market buyers
High market demand in regions with significant cardiovascular disease burden, including Africa, the Middle East, and Southeast Asia, driving consistent import and institutional procurement volumes
Target Export Markets
Africa
Nigeria, Kenya, Tanzania, Ghana, Uganda, Ethiopia, Zambia, Cameroon, Côte d’Ivoire.
Focus: FSC, NAFDAC registration support (Nigeria), PPB (Kenya), TFDA (Tanzania), PCPB (Ghana)
Language: English, French labeling available for Francophone Africa
Southeast Asia
Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Bangladesh
Focus: ACTD dossier format mandatory for ASEAN market registrations
Stability: Tropical formulations (ICH Zone IVb) critical for hospital cold-chain-free storage in this climate region
Latin America (LATAM)
Colombia, Peru, Ecuador, Bolivia, Guatemala, Honduras
Focus: Spanish labeling, USP pharmacopoeial standard preferred
Dossier: CTD format with local regulatory adaptation support
Middle East & CIS
Iraq, Yemen, Uzbekistan, Kazakhstan, Kyrgyzstan
Focus: GMP Certificate and CoPP are primary registration requirements
Language: Arabic and Russian labeling available on request
Export Packaging & Supply Chain
Primary Packaging Options
| Dosage Form | Packaging Options |
| Lyophilized Injection | Single-dose glass vials (e.g. 10 mL / 50 mL) with rubber stopper and aluminum flip-off seal; packed 1 vial/box or 10 vials/hospital pack |
| Bulk / Institutional Supply | Hospital and institutional procurement packs available on request |
Labeling & Customization
Private label manufacturing available with custom brand name and artwork
Multi-lingual labeling: English, French, Spanish, Portuguese, Arabic, Russian
Country-specific labeling compliance: NAFDAC text, KEBS, local registration number fields
Logistics & Supply
Incoterms: FOB, CIF, CFR, EXW as per buyer requirement
Shipment lead time: 45 to 60 days from order confirmation
Experienced in shipping to Africa, CIS, LATAM, and Southeast Asia
Why Source Isosorbide Mononitrate Lyophilized Injection From Us?
Frequently Asked Questions (FAQ)
Q1. Do you provide a dossier for Isosorbide Mononitrate Lyophilized Injection?
Yes. We provide complete dossiers in CTD, ACTD, and eCTD formats for Isosorbide Mononitrate Lyophilized Injection. The dossier includes Module 3 quality documentation, stability data (ICH Zone IVb for tropical climates), comparative pharmacokinetic references, and full site information.
Country-specific customization and regulatory guidance are available for your MOH submission.
Q2. Is your Isosorbide Mononitrate Lyophilized Injection manufactured in a dedicated/controlled facility?
Yes. Our Isosorbide Mononitrate Lyophilized Injection is manufactured in a dedicated sterile injectable / lyophilization suite under aseptic processing conditions.
This is fully documented in our Site Master File (SMF), available for regulatory submissions.
Q3. Which pharmacopoeial standard does your Isosorbide Mononitrate Lyophilized Injection comply with: BP, USP, or IP?
Our Isosorbide Mononitrate Lyophilized Injection is available compliant with BP / USP / IP.
Please specify your market requirement at the time of inquiry, and we will confirm the applicable standard for your order.
Q4. Can you supply Isosorbide Mononitrate Lyophilized Injection under our private label?
Yes, we offer private label manufacturing for Isosorbide Mononitrate Lyophilized Injection.
We handle packaging artwork, multilingual labeling (English, French, Spanish, Portuguese, Arabic), and country-specific regulatory label compliance.
Q5. What is the MOQ for Isosorbide Mononitrate Lyophilized Injection export?
MOQ varies by strength and pack size. Please get in touch with our export team with your product specification, target market, and estimated volume requirement for a tailored quotation and lead time confirmation.
Q6. Which countries do you export Isosorbide Mononitrate Lyophilized Injection to?
We currently export to 40+ countries across Africa, Southeast Asia, Latin America, and the Middle East & CIS.
Our regulatory team provides country-specific registration support for each market.
Q7. What documents do you provide with each Isosorbide Mononitrate Lyophilized Injection shipment?
Standard export documentation includes: Certificate of Analysis (CoA), Certificate of Pharmaceutical Product (CoPP), Free Sale Certificate (FSC), Method of Analysis (MOA), GMP Certificate, Packing List, Commercial Invoice, and Bill of Lading.
Additional documents (BMR, Stability Reports) available on request.
Q8. Does Isosorbide Mononitrate Lyophilized Injection require cold-chain storage during transit?
No. As a lyophilized powder for injection, the product is stable at controlled room temperature (below 25°C, protected from light).
It does not require cold-chain logistics, simplifying export handling compared with liquid injectable formulations.