Generic megestrol acetate is FDA-licensed for palliative treatment of advanced breast and endometrial carcinoma, and the originator brand Megace, UK-licensed for hormone-dependent neoplasms including breast cancer, sits alongside it on hospital and hospice formularies.
M Care Exports supplies Megace (megestrol acetate), a synthetic progestin licensed for the UK market by Bausch Health Ireland as Megace 160 mg tablets, alongside FDA-approved generic megestrol acetate tablets and oral suspension marketed in the US as Megace ES by Par Pharmaceutical. The UK Megace SmPC licenses it for hormone-dependent neoplasms including breast cancer; the US generic label additionally covers palliative treatment of advanced, recurrent, inoperable or metastatic endometrial carcinoma, and separately AIDS-related anorexia, cachexia or unexplained weight loss. M Care is a merchant exporter: we source Megace and generic megestrol through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Megestrol exporter and bulk supplier from India.
For hospital oncology pharmacy, hospice and tender-desk orders, M Care quotes megestrol acetate against buyer specification: brand (Megace) or generic, tablet strength (20 mg, 40 mg or 160 mg) or oral suspension (40 mg/mL or the non-interchangeable 125 mg/mL Megace ES concentration), and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the two oral-suspension concentrations are not mL-for-mL substitutable and each indication carries its own dosing range, we confirm the buyer's intended indication and formulation 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.
Synthetic progestin; antineoplastic and appetite-stimulant progestogen, sourced and documented for export.
Megestrol acetate is a synthetic progestin with antineoplastic activity against hormone-responsive breast and endometrial tumours, working partly by modifying other steroid hormone activity and by a direct cytotoxic effect on tumour cells; in AIDS-related wasting its appetite-stimulant effect is used separately, at a different dose range, for anorexia and cachexia. It is dosed orally as a tablet or oral suspension, not injected, and needs no reconstitution. The FDA generic label's two oncology indications are palliative treatment of advanced, recurrent, inoperable or metastatic carcinoma of the breast (160 mg/day) and of the endometrium (40-320 mg/day in divided doses), with a minimum two-month treatment period recommended before assessing efficacy. Megace is supplied as 20 mg and 40 mg generic tablets, a 160 mg branded tablet (Megace, UK), a 40 mg/mL generic oral suspension, and the branded 125 mg/mL Megace ES suspension for AIDS-related wasting, which is not substitutable on a millilitre basis with the lower-strength suspension.
Active ingredient
Megestrol acetate. Synthetic progestin; antineoplastic and appetite-stimulant progestogen.
Forms and strengths
20 mg tablet; 40 mg tablet; 160 mg tablet; 40 mg/mL oral suspension; 125 mg/mL oral suspension.
Indications
Megestrol acetate, a synthetic progestin indicated for palliative treatment of advanced, recurrent, inoperable or metastatic carcinoma of the breast or endometrium, and separately for AIDS-related anorexia, cachexia or unexplained significant weight loss. Supplied as originator-descended Megace and licensed generic tablets and oral suspension from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Tablet and oral suspension.
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 megestrol acetate are mainly hospital oncology and palliative-care pharmacies managing advanced breast or endometrial carcinoma, hospice and supportive-care formulary teams treating cancer- or HIV-related wasting, national and regional MoH tender desks running oncology and palliative-care formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting HIV-wasting management in markets where local registration is in place.
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 megestrol.
Megestrol dosing splits sharply by indication and formulation: breast carcinoma is dosed at 160 mg/day (40 mg four times daily), endometrial carcinoma at 40-320 mg/day in divided doses, and AIDS-related anorexia or cachexia at an initial 800 mg/day of the 40 mg/mL suspension or a 625 mg/day dose of the 125 mg/mL Megace ES suspension, so a tender specifying "megestrol suspension" without a concentration is ambiguous and should be queried before quoting. The two suspension strengths are not interchangeable on a millilitre-for-millilitre basis; dispensing the wrong concentration under-doses or overdoses the patient. Megestrol is not licensed as a prophylactic weight-loss agent, and treatable causes of weight loss (infection, malabsorption, endocrine or renal disease, malignancy) should be excluded before initiation. Thromboembolic phenomena, including thrombophlebitis and pulmonary embolism, have been reported with megestrol, some fatal, so patients with a history of thromboembolic disease warrant close surveillance. No cold-chain handling or reconstitution is required; tablets and suspension both travel on ambient-temperature logistics.
The documentation pack a regulator actually asks for.
As an oral solid or oral liquid dosage form, megestrol travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Megestrol acetate does not appear on the current WHO Model List of Essential Medicines, so buyers should treat it as a formulary-specific palliative and supportive-care agent rather than an EML-listed oncology first-line drug when building a tender specification. On the brand-versus-generic question, Megace is the UK-licensed brand, marketed there by Bausch Health Ireland, and Megace ES is the US brand marketed by Par Pharmaceutical; separately registered FDA-approved generic megestrol acetate tablets (20 mg, 40 mg) and 40 mg/mL oral suspension are also available in the US, while the UK electronic Medicines Compendium currently lists a single licensed megestrol product, so UK buyers should not assume generic competition is available there in the way it is in the US. Megestrol is not a scheduled or controlled substance in the markets we ship to.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 megestrol.
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 megestrol.
- 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.
Megestrol supply, the specific questions.
Does a generic version of Megace exist?
Yes, in the US. FDA-approved generic megestrol acetate tablets (20 mg, 40 mg) and 40 mg/mL oral suspension are separately manufactured and registered alongside the Megace and Megace ES brands. In the UK, the electronic Medicines Compendium currently lists a single licensed megestrol product, the Bausch Health 160 mg tablet, so buyers should not assume the same generic choice is available there.
Can M Care supply Megace to our market?
Yes, on an import basis. We source Megace through its licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths and formulations of megestrol are available, and why are there two suspension strengths?
20 mg and 40 mg generic tablets, the 160 mg branded Megace tablet, a 40 mg/mL generic oral suspension, and the 125 mg/mL Megace ES oral suspension used for AIDS-related wasting. The two suspension strengths are dosed differently and are not interchangeable on a millilitre-for-millilitre basis, so a tender or prescription should specify the concentration intended, not just "megestrol suspension". Tell us your indication, breast carcinoma, endometrial carcinoma or wasting, and we quote the strength and formulation accordingly.
Is megestrol acetate safe in pregnancy?
No. UK labelling advises against use in pregnancy and breastfeeding, noting a risk of fetal genital abnormalities if exposure occurs during the first four months. This should be flagged clearly on any dispensing record for a patient of childbearing potential, and treatable causes of weight loss should always be excluded before initiating megestrol for wasting.
What documentation does M Care provide with a megestrol shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. We also confirm current strength and formulation availability given megestrol's two non-interchangeable oral suspension concentrations.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.