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Dapoxetine hydrochloride is a short-acting SSRI approved for premature ejaculation in men aged 18 to 64. It comes as film-coated tablets in two strengths, 30 mg and 60 mg. Whether a batch performs the way the reference product does usually comes down to four things: assay, related substances, dissolution profile, and the documentation that sits behind them. What follows is what buyers normally confirm before a first order.
Dapoxetine is a selective serotonin reuptake inhibitor developed specifically for on-demand use. The compound was originally synthesized at Eli Lilly, transferred to Johnson & Johnson in 2003, and reached its first market approval in Finland and Sweden in February 2009 under the brand name Priligy. It is classified under ATC code G04BX14, other urologicals.
The mechanism is standard SSRI pharmacology. Dapoxetine inhibits the neuronal reuptake of serotonin, increasing serotonergic activity at pre- and post-synaptic receptors, which in turn delays the ejaculatory reflex.
What separates dapoxetine from older SSRIs is its pharmacokinetics. Absorption is fast, with peak plasma concentrations reached in roughly one to two hours, and elimination is rapid, with an initial half-life of about 1.5 to 1.6 hours. That profile is what makes on-demand dosing possible. A conventional SSRI with a 24-hour half-life would not work for an occasional need.
Absolute bioavailability is 42 percent, with a wide range of 15 to 76 percent between individuals. Plasma protein binding exceeds 99 percent. Clearance runs through multiple enzyme systems, mainly CYP2D6, CYP3A4 and FMO1.
Buyers comparing quotations need the same set of parameters from every supplier. These are the standard ones for dapoxetine hydrochloride.
Chemical name: (+)-(S)-N,N-dimethyl-(α)-[2-(1-naphthalenyloxy)ethyl]benzenemethanamine hydrochloride
CAS number: 129938-20-1 for the hydrochloride salt. The free base is 119356-77-3.
Molecular formula: C21H23NO·HCl
Molecular weight: 341.88
ATC code: G04BX14
Dosage form: film-coated tablet
Strengths: 30 mg and 60 mg, expressed as dapoxetine base, supplied as the hydrochloride salt
Specification basis: confirm whether your market requires a pharmacopoeial monograph or an in-house specification, and ask which analytical methods the supplier's specification is built on before contracting
Legal status: prescription only in the markets where it is approved
The strength figure matters commercially. A 30 mg tablet contains 30 mg of dapoxetine base, not 30 mg of the hydrochloride salt. The salt conversion factor is small but real, and a supplier quoting on the wrong basis will produce a tablet that is under-strength when assayed against the label claim.
The dosing logic explains why only two strengths exist and why both are ordered together rather than separately.
Recommended starting dose is 30 mg, taken approximately one to three hours before sexual activity. If the response is insufficient and side effects remain tolerable, the dose can be raised to a maximum of 60 mg. The maximum dosing frequency is once every 24 hours.
The tablet is swallowed whole with at least a full glass of water. It can be taken with or without food. A high-fat meal reduces peak concentration by about 10 percent and slightly delays the time to peak, changes that are not considered clinically meaningful.
Dapoxetine is not indicated for men under 18 or over 64, and it is contraindicated with monoamine oxidase inhibitors, with other SSRIs, with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir and clarithromycin-class agents, and in moderate to severe hepatic impairment. Alcohol is to be avoided during treatment because it compounds the risk of syncope and nervous system effects.
The most frequently reported adverse events in controlled trials, occurring in 5 percent or more of patients, are headache, dizziness, nausea, diarrhoea, insomnia and fatigue. Nausea and dizziness are the events most often leading to discontinuation.
Four test items account for most batch rejections and most complaints after delivery. Ask for the actual data, not a statement that the specification is met.
Assay. Content should sit within the compendial limits across the shelf life, not just at release. A batch released at 99 percent with a downward trend can fall below specification before expiry in a hot, humid market.
Related substances. The specified impurities for dapoxetine are dapoxetine-N-oxide, desmethyldapoxetine and didesmethyldapoxetine. Desmethyldapoxetine is pharmacologically equipotent to the parent compound, so its limit is not a formality. Impurity profiles also reveal whether the manufacturer controls the chiral centre, since dapoxetine is the (S)-enantiomer and the (R)-form is an impurity of process origin.
Dissolution. This is the parameter that separates a technically compliant tablet from a commercially usable one. A profile that matches the reference product across the pH range, and stays matched after accelerated stability, is what supports a biowaiver or a bridging study in your registration file. Ask for the full profile in three media, not a single-point result.
Content uniformity and moisture. Low-dose tablets are sensitive to blend uniformity and to water uptake during coating and storage. Both affect dissolution on stability.
The document set is usually the real differentiator between suppliers quoting similar prices. A manufacturer with a mature file can shorten your registration timeline by months.
Batch certificate of analysis, for the specific batch, not a representative sample from a previous campaign.
GMP certificate covering the tablet line, issued by a recognized authority, with the scope wording checked against the dosage form you are buying.
Drug master file or certificate of suitability, where the market you are registering in requires one. For a finished tablet this sits alongside the module 3 dossier rather than replacing it.
CTD module 3 content, including process validation summary, analytical method validation and specification justification.
Stability data at long-term and accelerated conditions, matched to the climatic zone of your market. Zone IVb buyers should ask specifically for 30 degrees Celsius at 75 percent relative humidity data.
Elemental impurity assessment per ICH Q3D and a nitrosamine risk evaluation. Regulators now expect the nitrosamine statement as a matter of routine, and a supplier who has to generate it after you ask will delay your filing.
Packaging configuration, minimum order quantity and lead time in writing, with the packaging material specified. Blister and bottle formats are not interchangeable for registration purposes.
Loncom manufactures dapoxetine hydrochloride tablets in 30 mg and 60 mg strengths. The product is approved and marketed in China, which means the formulation, the manufacturing process and the analytical methods have been reviewed by a national regulatory authority and the line is under routine inspection.
For overseas buyers, that domestic approval is a starting point rather than an end point. It confirms the product exists as a registered, commercially supplied tablet, and it gives you a documented process to review. What it does not replace is the market-specific filing work your own registration will require.
【To be completed by Loncom: annual tablet capacity and current free capacity for this product; GMP certificate reference and issuing authority; whether a DMF or CEP is held and in which jurisdictions; available pack sizes; minimum order quantity and standard lead time; whether reference product comparative dissolution data is available for licensing partners.】
Dapoxetine is not a treatment for erectile dysfunction, and it is not interchangeable with daily-dosed SSRIs used for depression. It is contraindicated in men with a history of mania or bipolar disorder, and it should not be combined with recreational serotonergic drugs. Buyers sourcing for markets where the indication is not approved should confirm the regulatory pathway before contracting, because the tablet cannot be sold on the strength of another country's approval.
Product data in this article is drawn from the Priligy (dapoxetine hydrochloride) prescribing information, the Australian product information for Priligy, and the approved Chinese labelling for dapoxetine hydrochloride tablets. Regulatory dates are as published by the respective authorities.
Consistent tablets are not the result of better claims. They are the result of a validated process that produces the same dissolution curve on the tenth batch as it did on the first.
What is Dapoxetine HCl Tablets used for?
Dapoxetine Hydrochloride Tablets are used for the treatment of premature ejaculation in adult men where approved by local regulatory authorities. Use should follow the locally approved prescribing information.
What strengths are available for Dapoxetine Tablets?
Dapoxetine tablets are available in strengths such as 30 mg and 60 mg in certain markets. Actual availability depends on the manufacturer's product portfolio and applicable market authorization.
How can pharmaceutical companies source Dapoxetine HCl Tablets?
Pharmaceutical companies, distributors and potential licensing partners can contact Bestcomm Pharma to confirm product availability, specifications, quality documentation and regulatory requirements for their target markets.
Does Bestcomm Pharma support international pharmaceutical cooperation?
Bestcomm Pharma offers an integrated pharmaceutical platform spanning drug development, manufacturing and commercialization. Potential partners can discuss suitable supply, regulatory collaboration, MAH cooperation and other feasible business arrangements, subject to product availability and applicable regulations.
