- Dosage: Mefenamic 250mg
- Packaging: 10 capsules/blister*10/box
- Shelf Life: 36months
Package:
Product Description
Mefenamic 250mg Capsules: 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.
Mefenamic 250mg Capsules is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the Analgesics & NSAIDs range overview.
- 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)
- 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)
- Age limits worth building into your labelling Ibuprofen is not indicated in children less than three months of age according to the Model List. Paediatric paracetamol dosing should follow national formulary weight bands. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Mefenamic 250mg Capsules. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.
Supply & Specification Data for Mefenamic 250mg Capsules
| Product Name | Mefenamic Acid Capsules 250mg (Mefenamic Acid Oral Capsules) |
| Specification | Each capsule contains: Mefenamic Acid 250mg |
| Dosage Form | Oral Hard Gelatin Capsule (for oral administration; swallow whole) |
| Active Ingredient | Mefenamic Acid |
| Pharmacological Class | Non-Steroidal Anti-Inflammatory Drug (NSAID) — Fenamate Class (Analgesic / Anti-Inflammatory / Antipyretic) |
| Route of Administration | Oral administration (swallow whole with water). Take with or after food or milk to reduce gastrointestinal irritation. Typically taken every 6 hours as needed, as directed by a healthcare professional. |
| 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: Diclofenac Sodium 50mg, Ibuprofen Suppository 50mg, Indomethacin Suppository 100mg, Naproxen Suppositories 250mg, Paracetamol Suppository 150mg, Aspirin 300mg Tablets, Paracetamol Diphenhydramine Chlorphenamine Tablets, Ibuprofen 100mg Tablets.
Testing, Monographs & Batch 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 Mefenamic 250mg Capsules 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 batch record for this product normally includes:
- Testing for water content and pH where applicable
- Testing for sterility and bacterial endotoxins (parenterals and ophthalmics)
- Testing for microbial limits and preservative efficacy (multi-dose presentations)
- Testing for heavy metals and elemental impurities
- Testing for packaging integrity and seal testing
- Testing for description and identification
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Pack Configuration, Artwork & Shipping Documents
- Pack size: Blister pack (PVC-Alu) or HDPE bottle, typically 10, 20, 30, or 100 capsules per blister pack or 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: 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.
Dossier, Authority Filings & Tender Documentation
Documents for Mefenamic 250mg Capsules 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.
- 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.
- 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.
The context for Mefenamic 250mg Capsules 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.
Buyer Questions about Mefenamic 250mg Capsules
What pack size is available for Mefenamic 250mg Capsules?
This presentation is normally supplied as Blister pack (PVC-Alu) or HDPE bottle, typically 10, 20, 30, or 100 capsules per blister pack or 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 Mefenamic 250mg Capsules?
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 Mefenamic 250mg Capsules 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 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.
Is diclofenac on the WHO Essential Medicines List?
No. The non-opioid analgesics named in section 2.1 are acetylsalicylic acid, ibuprofen and paracetamol. We supply diclofenac sodium in injectable and capsule form for markets whose national lists include it.
Other Analgesics & NSAIDs Products in This Range
- Diclofenac Sodium 50mg — 50mg
- Ibuprofen Suppository 50mg — 50mg
- Indomethacin Suppository 100mg — 100mg
- Naproxen Suppositories 250mg — 250mg
- Paracetamol Suppository 150mg — 150mg
- Aspirin 300mg Tablets — 300mg
Browse the full Analgesics & NSAIDs range; all Capsules; the complete product catalogue.
Request a Quotation for Mefenamic 250mg Capsules
For tenders and programme supply, send the line item, pack size, quantity and destination for Mefenamic 250mg Capsules 250mg. 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.
