Product Description
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.
- Paracetamol is an antipyretic and analgesic — not an anti-inflammatory The Model List carries a footnote stating paracetamol is not recommended for anti-inflammatory use due to lack of proven benefit to that effect. Marketing copy that positions paracetamol as an anti-inflammatory is inconsistent with the WHO listing. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- The Model List specifies the exact presentations Section 2.1 of the 24th WHO Model List (2025) lists acetylsalicylic acid (suppository 50–150 mg; tablet 100–500 mg), ibuprofen (oral liquid 100 mg/5 mL; tablet 200, 400 and 600 mg) and paracetamol (oral liquid 120 mg/5 mL or 125 mg/5 mL and 250 mg/5 mL; suppository 100 and 250 mg; tablet 250, 325 and 500 mg; dispersible tablet 100 and 250 mg). WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- Fever control is part of severe-disease management MSF guidance on severe malaria directs paracetamol in the event of high fever only — a reminder that in febrile illness the antipyretic is supportive care, not the disease treatment. MSF Medical Guidelines — Malaria (Chapter 4.3, Parasitic infections)
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 Name | Ibuprofen Tablets (Ibuprofen 100mg Oral Tablets) |
| Specification | Each tablet contains: Ibuprofen 100mg |
| Dosage Form | Oral Film-Coated Tablet (for oral administration) |
| Active Ingredient | Ibuprofen |
| Pharmacological Class | Non-Steroidal Anti-Inflammatory Drug (NSAID) / Analgesic / Antipyretic |
| Route of Administration | Oral administration (swallowed whole with water). Take with food or milk to reduce gastrointestinal irritation. |
| Storage | Store below 25°C, in a dry place, protected from light and moisture. Keep container tightly closed. Do not freeze. |
| Therapeutic group | Analgesics & NSAIDs — Analgesics & NSAIDs |
| Manufacturer | Sinophare Bio-technology Co., Ltd. (GMP, China) |
| Documentation supplied | COA, 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
- Aspirin 300mg Tablets — 300mg
- Paracetamol Diphenhydramine Chlorphenamine Tablets — 500mg
- Methamizole 500mg Tablets — 500mg
- Paracetamol 500mg Tablets — 500mg
- Paracetamol Effervescent 500mg Tablets — 500mg
- Ibuprofen Suppository 50mg — 50mg
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.
Sources & Regulatory Notes
- WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- MSF Medical Guidelines — Malaria (Chapter 4.3, Parasitic infections)
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.
