- Dosage: Progesterone 25mg
- Packaging:6 pics/ blister*2/box
- Shelf Life: 36 months
Package:
Product Description
Progesterone Suppository 25mg: What the Published Guidance Says
The obstetric emergency medicines and newborn-care antiseptics that sit on the WHO Model List — supplied with the labelling discipline these products demand.
Before Progesterone Suppository 25mg is quoted, we confirm the monograph, the strength on the artwork and the release testing required by your market — the points summarised here.
- Chlorhexidine for umbilical cord care is an EMLca medicine Section 22.7 of the Model List carries chlorhexidine 7.1% digluconate solution or gel — delivering 4% chlorhexidine — for umbilical cord care, added in 2013. MSF specifies a 3 g gel applied once daily for seven days to the tip, stump and base of the cord. WHO eEML — Chlorhexidine (umbilical cord care)
- Monitoring and the antidote Patellar reflex, blood pressure, heart and respiratory rate are checked every 15 minutes during the first hour, then hourly, with urine output checked hourly. If signs of overdose appear, magnesium sulfate is stopped and 1 g calcium gluconate given by slow intravenous injection as the antidote. MSF also notes magnesium sulfate should not be combined with nifedipine. MSF Essential Drugs — Magnesium sulfate injectable
- MSF's own warning: check the ampoule strength Because magnesium sulfate is supplied in several strengths, MSF explicitly instructs users to check the strength of the ampoule carefully before use, noting that 1 g ampoules exist alongside the 5 g presentation it describes. MSF Essential Drugs — Magnesium sulfate injectable
Each point above is reproduced because it has a practical consequence for Progesterone Suppository 25mg: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.
Progesterone Suppository 25mg — Supply Parameters
| Product Name | Progesterone Suppository 25mg (Vaginal Progesterone Suppository) |
| Specification | Each suppository contains: Progesterone 25mg in a suitable suppository base (e.g., cocoa butter or polyethylene glycol) |
| Dosage Form | Vaginal Suppository (for vaginal administration) |
| Active Ingredient | Progesterone (Natural Micronized Progesterone) |
| Pharmacological Class | Hormone / Progestogen (Natural Progesterone / Luteal Phase Hormone) |
| Route of Administration | Vaginal administration. Insert deep into the vagina. Typically used once or twice daily, as directed by a healthcare professional. |
| Storage | Store in a cool place or refrigerate (2°C to 8°C per label). Keep away from heat and direct sunlight. Keep suppositories in their sealed packaging until use. |
| Therapeutic group | Maternal & Newborn — Maternal & Newborn |
| 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: Metronidazole Suppository 500mg, Chlorhexidine Acetate Suppository 20mg, Erythromycin Suppositories 100mg, Martrine Suppository 50mg, Clotrimazole Vaginal Suppositories 150mg, hCG Injection 5000 IU, Magnesium Sulphate BP 10% 10mL.
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.
Release testing for Progesterone Suppository 25mg follows the monograph you nominate — USP, EP, BP or CP. If the presentation is not covered by a monograph, the specification is frozen in writing with your quality team before the batch is manufactured.
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 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)
- Testing for heavy metals and elemental impurities
- Testing for packaging integrity and seal testing
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Packaging, Labelling & Export
- Pack size: Individually sealed suppositories (blister or foil pouch); typically 10 or 20 suppositories per box. Non-standard pack sizes can be quoted against your artwork.
- Storage: Store in a cool place or refrigerate (2°C to 8°C per label). 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.
Registration, Dossier & Tender Support
The legal manufacturer named on every document for Progesterone Suppository 25mg is Sinophare Bio-technology Co., Ltd., DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. The same entity appears on the GMP certificate and on the dossier submitted to your regulator.
- 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.
- CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
Progesterone Suppository 25mg is presented here against obstetric and newborn-care medicines named in the WHO Model List. Inclusion in an essential-medicines list does not authorise sale in any particular country — the marketing authorisation for that market is a separate step.
Frequently Asked Questions
What pack size is available for Progesterone Suppository 25mg?
Standard commercial packaging for this line is Individually sealed suppositories (blister or foil pouch); typically 10 or 20 suppositories per box. Alternative pack sizes are produced to your specification and are supported by the corresponding stability data.
What documentation comes with a shipment of Progesterone Suppository 25mg?
The documentation set for every shipment includes the certificate of analysis (description, identification, assay, related substances), stability data for the marketed pack, and the site GMP certificate. Shelf life: 36 months.
Does the batch documentation for Progesterone Suppository 25mg support a registration filing?
The documentation set for every shipment includes the certificate of analysis (description, identification, assay, related substances), stability data for the marketed pack, and the 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 magnesium sulfate in the strengths used in obstetric protocols?
Yes. We supply magnesium sulfate injection and will mark the ampoule strength prominently, because MSF explicitly warns users to check the ampoule strength before use.
Can you supply chlorhexidine for umbilical cord care?
Yes — chlorhexidine 7.1% digluconate delivering 4% chlorhexidine, the concentration and indication carried in section 22.7 of the WHO Model List.
Related Maternal & Newborn Products
- Metronidazole Suppository 500mg — 500mg
- Chlorhexidine Acetate Suppository 20mg — 20mg
- Erythromycin Suppositories 100mg — 100mg
- Martrine Suppository 50mg — 50mg
- Clotrimazole Vaginal Suppositories 150mg — 150mg
- hCG Injection 5000 IU — 5000IU
Browse the full Maternal & Newborn range; all Suppositories; the complete product catalogue.
Request a Quotation for Progesterone Suppository 25mg
Tell us the monograph, pack size and quantity required for Progesterone Suppository 25mg 25mg, together with the destination market, and the quotation will state lead time and the documents that ship with the batch. Samples for registration can be added to the same order.
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.
