Ribavirin Injection 100mg | Broad-Spectrum Antiviral Infusion Solution

Sinophare-ribavirin injection
  • Dosage: Ribavirin 100mg
  • Volume: 1ml or 2ml per  Ampoule
  • Packaging: Sterile Ampoules for injection, 10 ampoules/tray*1 box
  • Shelf Life: 36months 

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Product Description

Product NameRibavirin Injection 100mg (Ribavirin Intravenous Injection / Infusion)
SpecificationEach ampoule contains: Ribavirin 100mg in 1mL (or appropriate volume) sterile solution for intravenous injection/infusion
Dosage FormSterile Solution for Intravenous Injection / Infusion (IV)
Active IngredientRibavirin (Synthetic Guanosine Nucleoside Analog Antiviral)
Pharmacological ClassAntiviral Agent (Nucleoside Analog / Broad-Spectrum Antiviral)
Route of AdministrationIntravenous (IV) injection or infusion only. Administered by healthcare professionals in clinical settings. May be given as slow IV injection or diluted for IV infusion.
PackagingAmpoules (glass), typically 1mL per ampoule; supplied in boxes of 5 or 10 ampoules
StorageStore below 25°C, protected from light. Do not freeze. Keep ampoules in the original carton to protect from light.
Shelf Life36 months (unopened)

Product Overview

Ribavirin Injection 100mg is a sterile solution of the synthetic guanosine nucleoside analog ribavirin, intended for intravenous injection or infusion. Ribavirin is a broad-spectrum antiviral agent active against a variety of RNA and DNA viruses.

Ribavirin Injection 100mg: What the Published Guidance Says

Systemic antifungals, antivirals and anthelmintics supplied with full batch documentation — including fluconazole at the injection concentration of 2 mg/mL carried on the WHO Model List, and albendazole as a listed intestinal anthelmintic.

Ribavirin Injection 100mg is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Antifungals & Antivirals range overview.

These points are quoted because they shape how Ribavirin Injection 100mg is specified, labelled and purchased — including strength selection, pack size and the artwork wording. Confirm each one against the approved product information in your market before finalising a purchase order.

Ribavirin Injection 100mg — Supply Parameters

Product NameRibavirin Injection 100mg (Ribavirin Intravenous Injection / Infusion)
SpecificationEach ampoule contains: Ribavirin 100mg in 1mL (or appropriate volume) sterile solution for intravenous injection/infusion
Dosage FormSterile Solution for Intravenous Injection / Infusion (IV)
Active IngredientRibavirin (Synthetic Guanosine Nucleoside Analog Antiviral)
Pharmacological ClassAntiviral Agent (Nucleoside Analog / Broad-Spectrum Antiviral)
Route of AdministrationIntravenous (IV) injection or infusion only. Administered by healthcare professionals in clinical settings. May be given as slow IV injection or diluted for IV infusion.
StorageStore below 25°C, protected from light. Do not freeze. Keep ampoules in the original carton to protect from light.
Therapeutic groupAntifungals & Antivirals — Antifungals & Antivirals
ManufacturerSinophare Bio-technology Co., Ltd. (GMP, China)
Documentation suppliedCOA, HPLC/GC data, stability data, dossier package

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Fluconazole Injection 200mg/100mL, Picrasma Anti-Dysentery Capsules 200mg, Amantadine 100mg Capsules, Albendazole 200mg Tablets.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Ribavirin Injection 100mg is released against the pharmacopoeial monograph named on your order (USP, EP, BP or CP). Where no monograph exists for the exact presentation, the specification is agreed with you in writing before manufacture and is attached to the certificate of analysis.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

  • Testing for description and identification
  • Testing for assay of the active substance
  • Testing for related substances and impurities
  • Testing for dissolution or release profile (solid oral forms)
  • Testing for uniformity of dosage units
  • Testing for water content and pH where applicable

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

  • Pack size: Ampoules (glass), typically 1mL per ampoule; supplied in boxes of 5 or 10 ampoules. Non-standard pack sizes can be quoted against your artwork.
  • Storage: Store below 25°C, protected from light. Do not freeze. Keep ampoules in the original carton to protect from light..
  • Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
  • Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
  • Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

Sinophare Bio-technology Co., Ltd. holds DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. That registration identifies the legal manufacturer on the certificate of analysis, the GMP certificate and the documents filed with your national medicines authority.

  • CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
  • Site Master File and GMP certificate for the manufacturing workshops.
  • Method validation, stability protocol and the shelf-life justification for the marketed pack.
  • Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
  • Tender and framework documentation, including pre-qualification questionnaires and sample logistics.

This page describes Ribavirin Injection 100mg as a product of the antifungal, antiviral and anthelmintic medicines named in the WHO Model List family. A WHO or national listing is a supply-context fact, not an approval in your market; marketing authorisation remains specific to each country.

Frequently Asked Questions

What pack size is available for Ribavirin Injection 100mg?

The reference pack is Ampoules (glass), typically 1mL per ampoule; supplied in boxes of 5 or 10 ampoules. Non-standard blister, bottle and carton configurations are quoted against your artwork, matched to the stability data already held for the presentation.

What documentation comes with a shipment of Ribavirin Injection 100mg?

Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months.

Does the batch documentation for Ribavirin Injection 100mg support a registration filing?

Each batch ships with a certificate of analysis covering description, identification, assay and related substances, plus stability data for the marketed pack and the GMP certificate of the manufacturing site. Shelf life: 36 months. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.

Is fluconazole on the WHO Essential Medicines List?

Yes. The 24th Model List carries fluconazole as a 50 mg capsule, injection 2 mg/mL in vial, oral liquid 50 mg/5 mL and powder for oral liquid.

What is fluconazole used for according to MSF guidance?

MSF lists oesophageal candidiasis, moderate to severe oropharyngeal candidiasis, secondary prophylaxis of recurrent candidiasis in immunocompromised patients, cryptococcal meningitis and secondary prophylaxis of cryptococcal infection.

Related Antifungals & Antivirals Products

Browse the full Antifungals & Antivirals range; all Injectables; the complete product catalogue.

Request a Quotation for Ribavirin Injection 100mg

Send the specification, pack size, quantity and destination market for Ribavirin Injection 100mg 100mg and we will confirm availability, lead time and documentation. Tender quantities and registration samples are handled on the same quotation.

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Sources & Regulatory Notes

Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.

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