Ibuprofen 100mg Tablets

ibuprofen-tablets
  • Dosage: Ibuprofen 100mg
  • Packaging: 10tablets/blister*10/box
  • Shelf Life: 36months 

Click to add this item to cart.

Product Description

Product NameIbuprofen Tablets (Ibuprofen 100mg Oral Tablets)
SpecificationEach tablet contains: Ibuprofen 100mg
Dosage FormOral Film-Coated Tablet (for oral administration)
Active IngredientIbuprofen
Pharmacological ClassNon-Steroidal Anti-Inflammatory Drug (NSAID) / Analgesic / Antipyretic
Route of AdministrationOral administration (swallowed whole with water). Take with food or milk to reduce gastrointestinal irritation.
PackagingBlister pack (PVC-Alu) or HDPE bottle, typically 10 or 20 tablets per blister strip, or 100 tablets per bottle
StorageStore below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze.
Shelf Life36 months (unopened)

Product Overview

Ibuprofen Tablets is an oral non-steroidal anti-inflammatory drug (NSAID) preparation containing Ibuprofen 100mg per film-coated tablet. Ibuprofen is a propionic acid derivative NSAID with analgesic, antipyretic, and anti-inflammatory properties. The lower 100mg strength formulation is suitable for pediatric use or for patients who require a lower starting dose. The product is formulated as film-coated tablets for convenient oral administration.

Ibuprofen 100mg Tablets: What the Published Guidance Says

The three non-opioid analgesics named on the WHO Model List — paracetamol, ibuprofen and acetylsalicylic acid — in the full range of oral, rectal and injectable presentations, plus the wider NSAID family.

Ibuprofen 100mg Tablets sits in the Analgesics & NSAIDs range. The notes below are the ones that most often change a specification, a label or a tender submission.

We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Ibuprofen 100mg Tablets. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.

Ibuprofen 100mg Tablets — Supply Parameters

Product NameIbuprofen Tablets (Ibuprofen 100mg Oral Tablets)
SpecificationEach tablet contains: Ibuprofen 100mg
Dosage FormOral Film-Coated Tablet (for oral administration)
Active IngredientIbuprofen
Pharmacological ClassNon-Steroidal Anti-Inflammatory Drug (NSAID) / Analgesic / Antipyretic
Route of AdministrationOral administration (swallowed whole with water). Take with food or milk to reduce gastrointestinal irritation.
StorageStore below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze.
Therapeutic groupAnalgesics & NSAIDs — Analgesics & NSAIDs
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: Aspirin 300mg Tablets, Paracetamol Diphenhydramine Chlorphenamine Tablets, Methamizole 500mg Tablets, Paracetamol 500mg Tablets, Paracetamol Effervescent 500mg Tablets, Ibuprofen Suppository 50mg, Indomethacin Suppository 100mg, Naproxen Suppositories 250mg.

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.

Every batch of Ibuprofen 100mg Tablets 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.

A typical release panel for this presentation covers:

  • Testing for heavy metals and elemental impurities
  • Testing for packaging integrity and seal testing
  • 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)

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

Packaging, Labelling & Export

  • Pack size: Blister pack (PVC-Alu) or HDPE bottle, typically 10 or 20 tablets per blister strip, or 100 tablets per bottle. Non-standard pack sizes can be quoted against your artwork.
  • Storage: Store below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze..
  • 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

Documents for Ibuprofen 100mg Tablets 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.

  • 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.

The context for Ibuprofen 100mg Tablets is its place among non-opioid analgesics and NSAIDs 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.

Frequently Asked Questions

What pack size is available for Ibuprofen 100mg Tablets?

This presentation is normally supplied as Blister pack (PVC-Alu) or HDPE bottle, typically 10 or 20 tablets per blister strip, or 100 tablets per bottle. Where your market requires a different count, bottle or carton, we quote to your artwork and extend the stability file to the new pack.

What documentation comes with a shipment of Ibuprofen 100mg Tablets?

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 Ibuprofen 100mg Tablets 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.

Which strengths of paracetamol oral liquid should we order?

The WHO Model List notes that offering both 120 mg/5 mL and 125 mg/5 mL on one market causes prescribing and dispensing confusion. We recommend selecting one strength per market and will supply accordingly.

Do you supply paracetamol suppositories?

Yes — 150 mg and paediatric strengths. The Model List specifies suppository strengths of 100 mg and 250 mg, and national formularies frequently add intermediates.

Related Analgesics & NSAIDs Products

Browse the full Analgesics & NSAIDs range; all Tablets; the complete product catalogue.

Request a Quotation for Ibuprofen 100mg Tablets

For tenders and programme supply, send the line item, pack size, quantity and destination for Ibuprofen 100mg Tablets 100mg. We return a quotation with lead time, documentation list and sample availability in one response.

Request a quotation

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.

<< return to products