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

Votrient (pazopanib) is now available as an FDA-approved generic alongside the originator brand, so hospital buyers can choose branded Novartis stock or a licensed generic tablet for the same renal cell carcinoma and sarcoma indications.

Votrient (pazopanib), originated by GlaxoSmithKline and now marketed by Novartis, treats advanced renal cell carcinoma and certain soft-tissue sarcomas. Generic pazopanib tablets are also FDA-approved from multiple manufacturers, including Indian majors such as Torrent, Aurobindo and Sun Pharma. M Care is a merchant exporter: we source both the originator brand and licensed generic pazopanib through CDSCO-licensed Indian channels and dispatch against buyer specification, never claiming to manufacture either.

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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

Pazopanib exporter and bulk supplier from India.

For tender and bulk hospital supply, M Care quotes pazopanib against the buyer's own specification: originator Votrient where the tender calls for the brand, or a named generic manufacturer where an INN-based or lowest-landed-cost tender applies. Because pazopanib is now multi-sourced, we can usually offer several manufacturer options against the same enquiry, each backed by its own CoA and regulatory dossier, so MoH and NGO procurement desks can compare on documentation and lead time rather than a single fixed source.

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

Multi-target tyrosine kinase inhibitor (VEGFR-1/2/3, PDGFR-alpha/beta, c-KIT), sourced and documented for export.

Pazopanib is an oral multi-target tyrosine kinase inhibitor (TKI). It blocks VEGFR-1, -2 and -3, PDGFR-alpha and -beta, and c-KIT, which starves tumours of the blood supply and signalling they depend on.

It is FDA-approved for advanced renal cell carcinoma and for advanced soft-tissue sarcoma in patients who have already had chemotherapy (or who progressed within 12 months of neoadjuvant or adjuvant treatment); the EMA EPAR licenses pazopanib for the same two disease areas in the EU (first-line advanced RCC, or after prior cytokine therapy; and selected advanced soft-tissue sarcoma subtypes after prior chemotherapy). Other licensed indications, if any, follow destination-country labelling.

Pazopanib is supplied as 200 mg and 400 mg film-coated tablets, taken orally once daily without food, at least one hour before or two hours after a meal. It is an oral solid dosage form: no cold chain is required, and it is stored at controlled room temperature per the manufacturer's labelling, not refrigerated.

Active ingredient

pazopanib hydrochloride. Multi-target tyrosine kinase inhibitor (VEGFR-1/2/3, PDGFR-alpha/beta, c-KIT).

Forms and strengths

200 mg tablet; 400 mg tablet.

Indications

Indicated for advanced renal cell carcinoma and for advanced soft-tissue sarcoma in patients who have received prior chemotherapy.

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 pazopanib typically include NHS trust oncology pharmacies, MoH cancer-centre tender desks across the GCC and Africa, licensed importers and wholesalers stocking oncology ranges, and hospital pharmacists managing individual patient or named-patient supply. Because both branded Votrient and generic pazopanib are available, tender desks often request both options in the same enquiry so they can compare price and lead time against a like-for-like specification.

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 pazopanib.

Pazopanib carries a boxed hepatotoxicity warning. Liver function tests (ALT, AST and bilirubin) should be checked before starting treatment, then at regular intervals through the early weeks of therapy and periodically thereafter for as long as the patient remains on drug; dose is interrupted, reduced or discontinued according to the degree of ALT and bilirubin elevation seen. Pharmacies dispensing pazopanib should flag it for structured LFT monitoring at intake, the same way they would for other hepatotoxic oncology orals.

Standard dosing is 800 mg once daily, taken on an empty stomach. Tablets must be swallowed whole; they must not be crushed or split, because breaking the tablet changes the absorption rate and increases systemic exposure compared with the intact tablet. This is a common substitution error worth flagging to ward staff moving a patient from another TKI regimen.

Dose reduction is required in moderate hepatic impairment (typically to 200 mg daily per label guidance), and pazopanib should not be used in patients with severe hepatic impairment. Strong CYP3A4 inhibitors and inducers both affect pazopanib exposure significantly, so a medicines-reconciliation check for interacting co-medication is worth doing at dispensing, not just at prescribing.

Because generic pazopanib is now FDA-approved from several manufacturers, substitution between brand and generic is a straightforward INN-level swap for tender purposes; the clinical monitoring burden (LFTs, blood pressure, QT considerations) is unchanged regardless of which manufacturer's tablet is dispensed.

Regulatory & quality

The documentation pack a regulator actually asks for.

As an oral solid, pazopanib does not carry cold-chain requirements; the documentation chain M Care builds around each shipment centres on batch-level CoA, 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. We do not hold WHO-GMP or WHO-PQ status ourselves; every batch we export originates from a WHO-GMP or, where applicable, EU-GMP-capable manufacturing partner, and we pass on that manufacturer's own certification rather than claiming it as our own.

On the brand-versus-generic question: Votrient remains available as Novartis-branded stock, and FDA-approved generic pazopanib is now supplied by multiple manufacturers, several of them Indian (Torrent, Aurobindo, Sun Pharma among others). We present this honestly to buyers as a genuine choice rather than steering tender desks toward one or the other; which option suits a given tender usually comes down to the tender's own brand-versus-generic specification and the buyer's cost and lead-time priorities.

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 pazopanib.
  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

Pazopanib supply, the specific questions.

Is there a generic version of Votrient (pazopanib)?

Yes. Generic pazopanib tablets are FDA-approved from several manufacturers, including Indian majors such as Torrent, Aurobindo and Sun Pharma, alongside originator Votrient from Novartis. Both are available through M Care's licensed export channels.

Can M Care supply Votrient to our market?

Yes. M Care sources Votrient and generic pazopanib through licensed Indian distribution channels and dispatches against your import basis and documentation requirements; we do not manufacture either product ourselves.

Does pazopanib need cold-chain shipping?

No. Pazopanib tablets are an oral solid dosage form stored at controlled room temperature per the manufacturer's labelling, not a cold-chain product.

What liver monitoring does pazopanib require?

Pazopanib carries a boxed hepatotoxicity warning. Liver function tests are checked before starting treatment and at regular intervals during therapy, with dose interruption, reduction or discontinuation guided by the degree of ALT and bilirubin elevation.

What strengths of pazopanib tablets are available?

Pazopanib is marketed as 200 mg and 400 mg film-coated tablets, both available through M Care against a standard 800 mg once-daily regimen or reduced-dose regimens.

What documentation does M Care provide with a pazopanib shipment?

Batch-level certificate of analysis, CDSCO export documentation, and CTD or eCTD-format dossier support where the destination regulator requires it for registration.

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 2026-08-28.

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.

Pazopanib enquiry

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