Chlorpheniramine Injection 20mg/2mL

Chlorpheniramine Injection 20mg/2mL | Antihistamine Allergy

Specification & Composition

  • Active Ingredient:Chlorpheniramine
  • Content Specification:20mg per 2mL single dose
  • Pharmaceutical Form:Sterile clear injection solution
  • Applicable Standard:International pharmacopoeia specification, hospital clinical grade
  • Storage Condition:Sealed storage, protected from light and high temperature
  • Product Features:Fixed standard dosage, rapid symptomatic relief, stable efficacy, suitable for clinical conventional use and large-scale hospital reserve

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Product Description

  • Product Name:Chlorpheniramine Injection
  • Specification:20mg/2mL
  • Therapeutic Category:Antihistamine Drugs / Anti-allergic Agents
  • Core Product Positioning:Classic first-generation anti-allergic injection for clinical symptomatic treatment
  • Indicated For:Relief of severe allergic reactions, urticaria, allergic dermatitis, drug allergy and hypersensitivity symptoms
  • Usage Scenario:Hospital emergency departments, general wards, dermatology departments and primary medical institutions
  • Applicable Clients:Global medical institutions, hospital procurement centers, pharmaceutical wholesalers and medical supply agencies

Product Overview

Chlorpheniramine Injection 20mg/2mL is a conventional first-generation H1 antihistamine widely used in clinical anti-allergic treatment. It effectively inhibits histamine-mediated allergic responses, rapidly relieving various acute allergic symptoms with stable and reliable therapeutic effects.

Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier: What the Published Guidance Says

The resuscitation, antidote and critical-care injectables that a functioning emergency department cannot run without — most of them named directly on the WHO Model List.

Buyers usually settle three things before ordering Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier: the pharmacopoeial monograph, the pack configuration, and the documents the destination authority will ask for.

We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.

Ordering Parameters for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier

Therapeutic groupEmergency & Critical Care — Emergency & Critical Care
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: Nimodipine Injection 10mg/50ml, Heparin Sodium Injection 2mL:5000IU, Citicoline Injection 2ml:250mg Ampoule, Aceglutamide Injection 100mg/5mL, Dobutamine Injection 12.5mg/mL 2mL, Diphenhydramine Injection 50mg/mL 2mL, Dexamethasone Injection 8mg/2mL, Acetylcysteine Injection 1g/5mL.

Pharmacopoeial Standard, Release Testing & COA

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.

Every batch of Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier is tested to the monograph stated on the purchase order. Where a monograph is silent on the presentation, we agree a written specification with you in advance and reference it on the certificate of analysis.

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

The quality control package for the marketed pack covers:

  • 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
  • Testing for sterility and bacterial endotoxins (parenterals and ophthalmics)

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

Packing, Labelling Languages & Export Paperwork

  • Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
  • Labelling: we typeset the carton and leaflet in English, Arabic, French, Russian and Spanish and in any further language your market requires, carrying your own brand where the local rules allow.
  • Export: commercial invoice, packing list, certificate of origin, GMP certificate, COA and the free-sale certificate issued by the country of manufacture whenever your customs or regulator asks for it.

Marketing Authorisation & Tender Support

Documents for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier are issued by Sinophare Bio-technology Co., Ltd. — DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. Keeping one legal manufacturer across the COA, the GMP certificate and the registration file avoids assessment queries later.

  • 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.
  • Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
  • Batch manufacturing and packaging records released for inspection on request during supplier audits.
  • Re-test or renewal support when the marketing authorisation comes up for variation or renewal.

The context for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier is its place among emergency and critical-care injectables named in the WHO Model List. Listing status informs how programmes specify a product; it is not a substitute for the import licence or marketing authorisation of the destination country.

Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier: Common Procurement Questions

How is Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier packaged?

Injection presentations are quoted to your pack specification, with the artwork, pack size and labelling language confirmed before manufacture.

What documentation comes with a shipment of Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier?

Shipments are accompanied by a certificate of analysis covering identification, assay and related substances, together with the marketed-pack stability data and the manufacturing site GMP certificate. Shelf life: 36 months.

Does the batch documentation for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier support a registration filing?

Shipments are accompanied by a certificate of analysis covering identification, assay and related substances, together with the marketed-pack stability data and the manufacturing site GMP certificate. 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.

Do emergency injectables come with endotoxin data?

Sterile injectables are supplied with sterility and bacterial endotoxin results in the batch certificate of analysis, alongside assay and related-substances data.

Which of these emergency medicines are on the WHO Model List?

Epinephrine (adrenaline), atropine, dexamethasone injection, calcium gluconate, acetylcysteine, furosemide and heparin appear on the Model List. Confirm current listing for every molecule against the Model List and your national essential medicines list.

Products Commonly Ordered with Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier

Browse the full Emergency & Critical Care range; all Injectables; the complete product catalogue.

Request a Quotation for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier

For tenders and programme supply, send the line item, pack size, quantity and destination for Chlorpheniramine Injection 20mg/2mL |GMP Manufacturer & Supplier 20mg/2mL. We return a quotation with lead time, documentation list and sample availability in one response.

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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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