WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Nolvadex (tamoxifen) is licensed for oestrogen-receptor-positive breast cancer at every stage, from metastatic disease to five-year adjuvant and preventive therapy, and generic tamoxifen citrate tablets now carry the great majority of tender and formulary volume.

M Care Exports supplies Nolvadex (tamoxifen), marketed in the UK by AstraZeneca, alongside FDA- and MHRA-licensed generic tamoxifen citrate tablets. It is an oral selective oestrogen receptor modulator dosed once or twice daily for hormone-receptor-positive breast cancer. M Care is a merchant exporter: we source Nolvadex and generic tamoxifen through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Tamoxifen exporter and bulk supplier from India.

For hospital oncology pharmacy, wholesaler and tender-desk orders, M Care quotes tamoxifen against buyer specification: brand (Nolvadex) or generic, 10 mg or 20 mg film-coated tablets, and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because tamoxifen sits on the WHO Model List of Essential Medicines for hormone-receptor-positive breast cancer and generic supply is broad and mature, most tenders specify generic tamoxifen citrate by INN rather than brand; we confirm the buyer's formulary preference and any paediatric-oncology or oral-liquid requirement 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.

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At a glance

Selective oestrogen receptor modulator (SERM), sourced and documented for export.

Tamoxifen is a selective oestrogen receptor modulator (SERM): it competitively binds the oestrogen receptor, acting as an anti-oestrogen in breast tissue while producing partial oestrogen-agonist effects in the endometrium and bone. It is dosed orally, not injected, and needs no reconstitution. The FDA label's flagship indications are treatment of oestrogen-receptor-positive metastatic breast cancer in women and men, adjuvant treatment of early-stage oestrogen-receptor-positive breast cancer, risk reduction of invasive breast cancer after breast surgery and radiation for ductal carcinoma in situ, and reduction of breast cancer incidence in women at high risk. Nolvadex is supplied as 10 mg and 20 mg film-coated tamoxifen citrate tablets, taken once daily for adjuvant and preventive use, or as divided morning-and-evening doses above 20 mg per day in metastatic disease; a sugar-free oral solution (Soltamox, 10 mg per 5 mL) is separately licensed in the US for patients unable to swallow tablets.

Active ingredient

Tamoxifen citrate. Selective oestrogen receptor modulator (SERM).

Forms and strengths

10 mg film-coated tablet; 20 mg film-coated tablet.

Indications

Tamoxifen, a selective oestrogen receptor modulator indicated for oestrogen-receptor-positive metastatic and early-stage breast cancer, ductal carcinoma in situ risk reduction and preventive therapy in high-risk women. Supplied as originator Nolvadex and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Oral. Film-coated tablet.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 tamoxifen are mainly hospital and outpatient oncology pharmacies dispensing adjuvant and metastatic breast cancer therapy, national and regional MoH tender desks running oncology and NCD formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting breast cancer treatment access in markets where local registration is in place. Because tamoxifen is an oral essential medicine rather than a specialist infusion, it also features on primary and secondary-care formularies well beyond dedicated cancer centres.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on tamoxifen.

Tamoxifen dosing is indication-led: adjuvant and preventive therapy runs at a fixed 20 mg once daily for five years, while metastatic disease is dosed at 20 to 40 mg daily, with doses above 20 mg split into morning and evening administration rather than given as a single dose. Concomitant strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion) can blunt conversion to the active metabolite endoxifen, so a formulary substitution to one of these antidepressants during tamoxifen therapy is worth flagging to the prescriber. Tamoxifen carries a boxed warning for uterine malignancies, stroke and pulmonary embolism when used for risk reduction, so any abnormal vaginal bleeding, leg swelling or sudden breathlessness in a patient on therapy warrants prompt referral rather than routine follow-up. It is teratogenic and contraindicated in pregnancy, and co-administration with anastrozole is contraindicated. No cold-chain handling or reconstitution is required; tablets store at controlled room temperature.

Regulatory & quality

The documentation pack a regulator actually asks for.

As an oral solid dosage form, tamoxifen 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. Tamoxifen is listed on the WHO Model List of Essential Medicines, on the complementary list for hormone-receptor-positive metastatic breast cancer, first added in 1984 and re-endorsed in the Committee's 2015 review; patents have expired in most jurisdictions. On the brand-versus-generic question, Nolvadex remains AstraZeneca's branded originator product in the UK, while in the US, FDA-approved generic tamoxifen citrate tablets from multiple manufacturers are now the market standard and Nolvadex brand tablets are no longer commercially available there. Most GCC and African tenders we see specify generic tamoxifen citrate by INN rather than the Nolvadex brand, reflecting the drug's essential-medicine, off-patent status.

Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for tamoxifen.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Tamoxifen supply, the specific questions.

Does a generic version of Nolvadex exist?

Yes, and it accounts for most global supply. FDA-approved generic tamoxifen citrate tablets from multiple manufacturers are the current US market standard, where Nolvadex brand tablets are no longer commercially available; Nolvadex remains AstraZeneca's branded product in the UK and other markets. M Care checks the destination regulator's registration status before quoting brand or generic against a specific tender.

Can M Care supply Nolvadex to our market?

Yes, on an import basis. We source Nolvadex through AstraZeneca's licensed Indian distribution channels, and generic tamoxifen citrate tablets through licensed WHO-GMP manufacturer lines, dispatching against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.

What strengths and forms of tamoxifen are available?

10 mg and 20 mg film-coated tamoxifen citrate tablets, matching the Nolvadex strengths and the standard generic presentation. A branded sugar-free oral solution (Soltamox, 10 mg per 5 mL) is also FDA-licensed in the US for patients who cannot swallow tablets. Tell us your indication and dosing protocol and we quote the strength split accordingly.

Is tamoxifen on the WHO Essential Medicines List?

Yes. Tamoxifen has been listed on the WHO Model List of Essential Medicines since 1984, on the complementary list for treatment of hormone-receptor-positive metastatic breast cancer, and was specifically re-endorsed in the Expert Committee's 2015 review. Patents have expired in most jurisdictions, which is part of why generic supply is so broad.

Is tamoxifen safe in pregnancy?

No. Tamoxifen is teratogenic and contraindicated in pregnancy, and carries a boxed warning for uterine malignancies, stroke and pulmonary embolism when used for breast cancer risk reduction. Concurrent use with anastrozole is also contraindicated. Any patient of childbearing potential should be counselled on non-hormonal contraception before starting therapy.

What documentation does M Care provide with a tamoxifen 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. Because most GCC and African tenders specify generic tamoxifen citrate by INN, we also confirm the sourcing partner's WHO-GMP status and current registration in the buyer's market before quoting.

Sources and review

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.

Tamoxifen enquiry

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.

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