Naproxen Suppositories 250mg | NSAID for Pain, Fever & Inflammation Relief

Naproxen Suppositories 250mg: 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.

This page collects the supply-relevant facts for Naproxen Suppositories 250mg — specification, testing, packaging and the registration paperwork that travels with the batch.

• 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)
• A strength-confusion warning that matters commercially The Model List itself warns that the presence of both 120 mg/5 mL and 125 mg/5 mL paracetamol oral liquid strengths on the same market would cause confusion in prescribing and dispensing and should be avoided. Country programmes should therefore settle on one strength. 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 Naproxen Suppositories 250mg. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.

How Naproxen Suppositories 250mg Is Tested and Released

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 Naproxen Suppositories 250mg 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.

Release testing on this presentation is built around:

• 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)
• Testing for microbial limits and preservative efficacy (multi-dose presentations)

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

How Naproxen Suppositories 250mg Is Packed, Labelled and Shipped

• Pack size: Individually sealed suppositories (blister or foil pouch); typically 10 suppositories per box. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store in a cool place (below 25°C). Keep away from heat and direct sunlight. Keep suppositories in their sealed packaging until use..
• Shelf life: 36 months (unopened, when stored as directed). 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.

Regulatory Support for Naproxen Suppositories 250mg

Documents for Naproxen Suppositories 250mg 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.

• 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.
• 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.

The context for Naproxen Suppositories 250mg 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.