Lupron Depot, sold in the UK as Prostap and across the EU as Eligard, is a GnRH agonist licensed for advanced prostate cancer and, in lower depot strengths, for endometriosis and central precocious puberty, and generic leuprolide acetate injections are now approved alongside the originator brands.
M Care Exports supplies Lupron Depot (leuprolide acetate), marketed in the UK as Prostap and across continental Europe as Eligard, a depot gonadotropin-releasing hormone (GnRH) agonist dosed once every one, three, four or six months by intramuscular or subcutaneous injection. M Care is a merchant exporter: we source the originator brands and FDA and MHRA-approved generic leuprolide acetate injections through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Leuprolide exporter and bulk supplier from India.
For hospital oncology pharmacy, wholesaler and tender-desk orders, M Care quotes leuprolide against buyer specification: brand (Lupron Depot, Prostap or Eligard) or generic, strength and depot interval (1-month, 3-month, 4-month or 6-month), and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because leuprolide is a dual-chamber or reconstituted depot kit rather than a ready-to-use vial, and because the EMA has flagged handling errors with leuprorelin depot products, we confirm the buyer's preferred presentation and reconstitution training needs 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.
Gonadotropin-releasing hormone (GnRH) agonist; synthetic nonapeptide analogue, sourced and documented for export.
Leuprolide (leuprorelin outside the US) is a synthetic nonapeptide analogue of gonadotropin-releasing hormone (GnRH). Given continuously as a depot, it first stimulates then downregulates pituitary gonadotropin secretion, suppressing testicular testosterone and ovarian oestrogen production to near-castrate levels within roughly two to four weeks. It is injected, not taken orally, and depot presentations require reconstitution with the supplied diluent immediately before use. The flagship US label indication is advanced prostate cancer, and the UK/EU SmPC for the same molecule extends to endometriosis, hormone-responsive breast cancer in pre- and perimenopausal women, and central precocious puberty in children, so destination-country labelling should be checked before a quote is finalised. Lupron Depot, Prostap and Eligard are supplied across a strength range from 3.75 mg to 45 mg, matched to depot interval rather than a single fixed dose.
Active ingredient
Leuprolide acetate. Gonadotropin-releasing hormone (GnRH) agonist; synthetic nonapeptide analogue.
Forms and strengths
3.75 mg powder for prolonged-release suspension for injection, 1-month depot; 7.5 mg powder for depot suspension for injection, 1-month depot; 11.25 mg powder for prolonged-release suspension for injection, 3-month depot; 22.5 mg powder for depot suspension for injection, 3-month depot; 30 mg powder for depot suspension for injection, 4-month depot; 45 mg powder for depot suspension for injection, 6-month depot.
Indications
Leuprolide acetate (leuprorelin), a GnRH agonist depot injection indicated for advanced prostate cancer and, in lower-strength presentations, endometriosis and central precocious puberty. Supplied as originator Lupron Depot/Prostap/Eligard and licensed generic leuprolide acetate injection from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Intramuscular, Subcutaneous. Powder for prolonged-release suspension for injection (depot kit).
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 leuprolide are mainly hospital oncology and urology pharmacies managing advanced prostate cancer patients on androgen-deprivation therapy, gynaecology and reproductive-endocrinology units treating endometriosis, paediatric endocrinology clinics managing central precocious puberty, national and regional MoH tender desks running oncology and hormone-therapy formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting cancer-care access 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 leuprolide.
Leuprolide depot kits are reconstituted immediately before injection and, per the Lupron Depot label, the suspension must be administered within two hours of mixing; different depot strengths and brands are not interchangeable mid-course because their release characteristics differ, so a patient started on one presentation should stay on it. At treatment initiation in prostate cancer, leuprolide causes a transient testosterone surge ("flare") before suppression takes hold, so an anti-androgen is typically co-prescribed for the first two to four weeks to cover symptomatic patients, particularly those with vertebral metastases or urinary obstruction risk. UK/EU labelling for leuprorelin depot carries warnings for depression, seizure, idiopathic intracranial hypertension and reduced bone mineral density on long-term therapy, and the EMA has separately flagged handling errors with leuprorelin depot kits, so reconstitution training on the specific presentation supplied matters as much as the strength itself. Lupron Depot kits store at controlled room temperature (20 to 25 degrees C); buyers should confirm the storage condition printed on the specific brand and strength they order, as this can vary by presentation.
The documentation pack a regulator actually asks for.
Leuprorelin (the INN; leuprolide is the US adopted name for the same acetate salt) has been on the WHO Model List of Essential Medicines since 2015, listed for malignant neoplasms of breast and prostate in 7.5 mg and 22.5 mg prefilled-syringe strengths, which gives tender desks a defensible essential-medicines basis for including it on an oncology or hormone-therapy formulary. On the brand-versus-generic question, buyers genuinely have a choice: Lupron Depot (AbbVie, US), Prostap (Takeda, UK) and Eligard (Recordati, EU) remain the originator depot products, and FDA-approved generic leuprolide acetate injection is separately registered in the US from manufacturers including Sandoz and Amneal, though generic competition for the long-acting depot presentations specifically is narrower than for oral generics. Leuprolide is not a controlled substance and needs no narcotics licensing, but as a depot injectable it needs correct reconstitution documentation and cold-chain or controlled-room-temperature handling as specified by the individual brand, plus batch-level certificate of analysis and CDSCO export documentation from the Indian side. The EMA's referral on leuprorelin depot products found that handling errors had caused some patients to receive an incomplete dose, which is a live reason MoH and hospital tender desks now ask suppliers to confirm administration training and updated packaging alongside the standard regulatory dossier.
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 leuprolide.
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 leuprolide.
- 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.
Leuprolide supply, the specific questions.
Does a generic version of Lupron Depot exist?
Yes, in the US market. FDA-approved generic leuprolide acetate injection is registered from manufacturers including Sandoz and Amneal. Generic competition is narrower for the long-acting depot presentations than for oral medicines, and registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Lupron Depot, Prostap or Eligard to our market?
Yes, on an import basis. We source the originator brands through their licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths and dosing intervals are available?
Depot strengths span 3.75 mg to 45 mg, matched to a 1-month, 3-month, 4-month or 6-month injection interval depending on the brand and indication. Tell us the intended indication (prostate cancer, endometriosis or precocious puberty) and dosing schedule and we quote the strength accordingly.
Is leuprolide on the WHO Essential Medicines List?
Yes. Leuprorelin has been listed since 2015 for malignant neoplasms of breast and prostate, in 7.5 mg and 22.5 mg prefilled-syringe strengths. This gives tender desks a recognised essential-medicines basis for stocking it on an oncology formulary.
Why does leuprolide sometimes cause a testosterone flare at the start of treatment?
Leuprolide first stimulates the pituitary before downregulating it, so testosterone can rise transiently for the first one to two weeks of prostate cancer treatment before suppression takes hold. Prescribers typically cover this with a short course of anti-androgen therapy, particularly in patients with vertebral metastases or urinary obstruction risk. This is standard practice per the US and UK product labelling, not a supply issue.
What documentation and handling guidance does M Care provide with a leuprolide shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, CTD/eCTD-aligned dossier support where the destination regulator requires local registration, and the manufacturer's reconstitution and storage instructions for the specific brand and strength supplied, given the EMA's specific guidance on avoiding handling errors with leuprorelin depot kits.
Are Lupron Depot, Prostap and Eligard interchangeable?
They are the same active substance, leuprolide acetate, but the depot formulations release the drug at different rates and are not licensed as interchangeable mid-course. A patient started on one brand and strength should generally continue on that same presentation for the remainder of a treatment cycle, so pack-mix planning should reflect which specific product a tender or prescriber has specified.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.