Sexual & Reproductive Health
PDE5 inhibitors and premature-ejaculation treatments supplied to the same documentation standard as the rest of our range, for markets where these products are registered.
This is a category where documentation, not list status, is the differentiator. Products here are heavily regulated and frequently counterfeited, so the procurement question is not price per tablet but verified assay, dissolution equivalence and traceable batch documentation from a manufacturer you can audit.
At a glance
- We supply vardenafil, tadalafil, dapoxetine and a tadalafil/dapoxetine combination tablet.
- We do not cite WHO Model List status in this category — the argument is the analytical standard.
- Every batch is released against a COA covering assay, related substances and dissolution.
- Combination products require their own registration and are not covered by the single-agent approval.
- This category is a known target for falsified products, so batch traceability matters more than usual.
01What the published guidance says
Every statement below is drawn from WHO or MSF published material and linked to its source. We summarise; we do not reproduce. Statements marked as our own are commercial positions, not clinical guidance.
Why the WHO Model List is narrow by design
WHO selects essential medicines on public health relevance, evidence of benefits and harms, and with consideration of costs, affordability and other relevant factors. The Model List represents only a small proportion of the medicines available globally and is revised every two years through an evidence-based process. We therefore do not present list status as supporting evidence for the products in this group — the analytical and documentation standard is the argument, and that is what a regulator will assess.
What we verify before dispatch
Each batch is released against its certificate of analysis covering assay, related substances and dissolution. Container-closure and stability data are supplied with the dossier package, together with registration support documents for national filings.
A category where documentation is the differentiator
Products in this category are frequently targeted by counterfeiters and are heavily regulated in most markets. The procurement priority is therefore not price per tablet but verified assay, dissolution equivalence and traceable batch documentation from a manufacturer you can audit.
02Products in this therapeutic group
Each entry links to its full specification page.
| Product | Dosage form | Presentation notes | Detail |
|---|---|---|---|
| Vardenafil 20mg Tablets | Tablet | View Vardenafil 20mg Tablets → | |
| Tadalafil 20mg Tablets | Tablet | View Tadalafil 20mg Tablets → | |
| Tadalafil and Dapoxetine compound tablets | Tablet | View Tadalafil and Dapoxetine compound tablets → | |
| Dapoxetine Hydrochloride 30mg Tablets | Tablet | View Dapoxetine Hydrochloride 30mg Tablets → |
4 products in this group · part of 186 finished dosage forms across 14 therapeutic areas.
03Specifying your order
The five things worth stating on a purchase order for this group, so the quotation comes back right first time.
Strength and form
State the milligram strength and the tablet format, including whether a film coat is required.
Dissolution profile
Specify the dissolution method and acceptance criteria your regulator expects, as these differ between markets.
Prescription labelling
Confirm the prescription-medicine labelling and patient information requirements for the destination market.
Combination registration
If you are ordering a combination product, confirm that it holds its own registration in your market.
Traceability
Specify the batch traceability information required, so the consignment can be verified against falsified-product alerts.
04How we supply it
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
PDE5 inhibitors
Vardenafil 20 mg and tadalafil 20 mg tablets.
Premature ejaculation
Dapoxetine hydrochloride 30 mg tablets.
Combination
Tadalafil and dapoxetine compound tablets, where registered in the destination market.
Documentation
COA with assay, related substances and dissolution data, plus stability packages, DMF and registration support documents.
05Safety, labelling & regulatory notes
Points worth carrying into your tender, label review or clinical briefing.
- These products are prescription medicines in most markets. Promotional material must not present them as general-wellness or over-the-counter items.
- PDE5 inhibitors have documented interactions with nitrates. Confirm the approved prescribing information for each destination market.
- This category is a known target for falsified products. Buyers should verify batch documentation and the manufacturer's authorisation for their market on every order.
- Confirm local registration status. Combination products in particular require their own approval and are not covered by the single-agent registration.
06Questions buyers ask
6 answers covering specification, documentation and regulatory questions for this group.
Which products do you supply in this category?
Do you cite WHO listing for these products?
What documentation accompanies an order?
Do you supply these as prescription-only presentations?
Can you supply tadalafil and dapoxetine as a combination tablet?
What dissolution data comes with the batch?
07Related therapeutic areas
Adjacent groups you may want to combine on one purchase order.
Request a quotation for Sexual Health
Send us the products, strengths and pack sizes you need, together with the destination country, and we will return a quotation with the documentation package and lead time. Registration support documents are provided with every order.
Request a quotation →