Avodart (dutasteride) is licensed for symptomatic benign prostatic hyperplasia in men with an enlarged prostate, and FDA and MHRA-approved generic dutasteride capsules are available alongside the originator brand and the dutasteride/tamsulosin combination sold as Combodart or Jalyn.
Avodart (dutasteride), originated by GlaxoSmithKline (GSK) and also marketed with tamsulosin as Combodart or Jalyn, is a once-daily oral 5-alpha reductase inhibitor for benign prostatic hyperplasia. M Care Exports is a merchant exporter: we source the GSK brand and FDA and MHRA-approved generic dutasteride capsules through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Dutasteride exporter and bulk supplier from India.
For hospital urology, wholesaler and tender-desk orders, M Care quotes dutasteride capsules against buyer specification: brand (Avodart) or generic, monotherapy or the fixed-dose dutasteride/tamsulosin combination where a market authorises it, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because dutasteride carries handling and blood-donation precautions that differ from most oral solids, we confirm the buyer's packaging and patient-information-leaflet requirements before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
5-alpha reductase inhibitor (Type 1 and Type 2 isoenzyme), sourced and documented for export.
Dutasteride is a synthetic 4-azasteroid that inhibits both the Type 1 and Type 2 isoenzymes of 5-alpha reductase, blocking conversion of testosterone to dihydrotestosterone (DHT) and shrinking prostate volume over time. It is dosed orally as a soft gelatin capsule, not injected, and needs no reconstitution. The MHRA and FDA labels' flagship indication is symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, including a reduction in the risk of acute urinary retention and BPH-related surgery. Symptom response builds gradually: the UK SmPC states it can take up to six months before a response is achieved, though some improvement may be seen earlier. Avodart is supplied as a 0.5mg oblong soft gelatin capsule, taken once daily with or without food, swallowed whole and never chewed or opened.
Active ingredient
Dutasteride. 5-alpha reductase inhibitor (Type 1 and Type 2 isoenzyme).
Forms and strengths
0.5 mg soft gelatin capsule.
Indications
Dutasteride, a dual 5-alpha reductase inhibitor indicated for symptomatic benign prostatic hyperplasia in men with an enlarged prostate, used alone or combined with tamsulosin. Supplied as originator Avodart and licensed generic capsules from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Soft gelatin capsule.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for dutasteride are mainly hospital and community urology pharmacies managing men on long-term BPH therapy, national and regional MoH tender desks running non-communicable-disease and urology formulary lists, licensed pharmaceutical wholesalers and importers, and men's-health procurement programmes in markets where dutasteride or its combination product is registered locally.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on dutasteride.
Dutasteride is dosed at a flat 0.5mg once daily regardless of renal function or age, with no titration schedule, so pack planning is simpler than for most urology lines; the complexity sits in handling, not dosing. The capsule shell prevents contact with the drug in normal use, but a leaking or damaged capsule exposes skin to a compound absorbed transdermally, so patient counselling and pharmacy handling should flag that women, children and adolescents must not touch a leaking capsule. Dutasteride is contraindicated in pregnancy: male patients should use a condom during intercourse with a pregnant or potentially pregnant partner. Because the drug's elimination half-life runs three to five weeks, with detectable serum levels for four to six months after the last dose, men on dutasteride should not donate blood until six months after their last dose, to prevent transfusion exposure to a pregnant recipient. Dutasteride also lowers serum PSA by roughly half within three to six months of starting therapy, so any PSA drawn for prostate-cancer screening in a man on therapy needs doubling before comparison against a standard reference range. No cold-chain handling is required.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, dutasteride travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; UK SmPC storage guidance is do not store above 30 degrees Celsius, with a four-year shelf life at manufacture. Dutasteride does not appear on the current WHO Model List of Essential Medicines and it is not a controlled substance in the markets M Care serves, so buyers should treat it as a formulary-specific urology line rather than an EML-mandated agent when building a tender specification. On the brand-versus-generic question, Avodart remains the GSK originator; FDA-approved generic dutasteride entered the US market in 2015, and the UK market now carries several MHRA-licensed generic dutasteride lines (including Aurobindo, Strides and Ennogen), so buyers genuinely have a brand-or-generic choice for the monotherapy capsule. The fixed-dose dutasteride/tamsulosin combination is marketed in the UK as Combodart (GSK) and in the US as Jalyn; buyers in other regions should confirm local branding and registration status at enquiry stage, since M Care sources against the buyer's specification rather than assuming brand names carry across markets. Buyers running multi-year tenders should confirm lead times at quote stage, as with any generic line.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside dutasteride.
Alfuzosin
Another urology & nephrology line ordered on the same formularies.
Flavoxate
Another urology & nephrology line ordered on the same formularies.
Mirabegron
Another urology & nephrology line ordered on the same formularies.
All urology & nephrology
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for dutasteride.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Dutasteride supply, the specific questions.
Does a generic version of Avodart exist?
Yes. FDA-approved generic dutasteride capsules have been available in the US since 2015, and MHRA-licensed generic dutasteride is registered and marketed in the UK, including lines from Aurobindo, Strides and Ennogen. M Care sources either the GSK originator brand or licensed generic dutasteride against the buyer's specification.
What is the difference between dutasteride alone and Combodart or Jalyn?
Dutasteride alone (Avodart) is a single-ingredient 5-alpha reductase inhibitor. Combodart (UK) and Jalyn (US) are fixed-dose combinations of 0.5mg dutasteride and 0.4mg tamsulosin, indicated for symptomatic BPH where combination therapy is clinically appropriate. Buyers should specify which product a tender requires, since M Care sources them as separate lines and brand names differ by market.
Why does a men's prostate medicine carry a pregnancy warning?
Dutasteride is contraindicated in pregnancy because it can harm the sexual development of a male foetus if absorbed by a pregnant woman. The risk arises from skin contact with a leaking capsule or from semen exposure, so labelling instructs male patients to use a condom with a pregnant or potentially pregnant partner, and instructs women, children and adolescents to avoid contact with a leaking capsule.
How long does dutasteride take to improve BPH symptoms?
Response builds gradually. The UK SmPC states it can take up to six months of continuous once-daily dosing before the full response to treatment is achieved, so buyers and prescribers should not expect rapid symptom change in the first few weeks.
Does dutasteride affect PSA testing for prostate cancer screening?
Yes. Dutasteride lowers serum PSA by approximately 50% within three to six months of starting therapy. Any PSA result taken while a patient is on dutasteride should be doubled before comparison against a standard reference range, and a new baseline PSA should ideally be established once treatment has been running for several months.
Is dutasteride a controlled substance, and does it need cold-chain shipping?
No. Dutasteride is not a controlled substance in the markets M Care serves and, as an oral soft gelatin capsule, it ships and stores at standard ambient conditions (do not store above 30 degrees Celsius per UK labelling), not on a validated cold-chain lane.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
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