Venclexta (venetoclax) is a BCL-2 inhibitor licensed for CLL/SLL and, in combination regimens, for newly diagnosed AML in patients ineligible for intensive chemotherapy, and every course starts with a mandatory ramp-up schedule to manage tumour lysis syndrome risk.
Venclexta (venetoclax) is AbbVie's originator BCL-2 inhibitor, supplied only through licensed distribution channels, not generic manufacture. M Care sources it as a merchant exporter for hospital pharmacies, oncology centres and tender desks across our 49 served markets, working on a quote basis against each buyer's import documentation.
Venetoclax exporter and bulk supplier from India.
For hospital and MoH tender volumes, the Mumbai desk quotes Venclexta against a specific market's import licence and cold-chain-free storage requirements, since venetoclax tablets do not need refrigeration. Lead times and batch allocation are confirmed once we have the buyer's licence, destination country and required pack count; we do not publish prices and each enquiry is priced individually through licensed Indian distribution channels of the originator.
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.
BCL-2 (B-cell lymphoma 2) inhibitor, selective apoptosis-restoring targeted oncology agent, sourced and documented for export.
Venetoclax is a selective, orally administered BCL-2 (B-cell lymphoma 2) inhibitor. It restores apoptosis in leukaemic cells that overexpress BCL-2 by displacing pro-apoptotic proteins from the BCL-2 protein, triggering programmed cell death.
Under the FDA label, Venclexta is indicated for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), in combination with obinutuzumab or rituximab or as monotherapy in defined settings, and in combination with azacitidine, decitabine or low-dose cytarabine for newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or with comorbidities precluding intensive induction chemotherapy. In February 2026 the FDA additionally approved venetoclax combined with acalabrutinib as a fixed-duration, all-oral regimen for previously untreated CLL. The EMA-approved Venclyxto label covers equivalent CLL and AML combination positioning under EU labelling; buyers should confirm the exact approved combination and line of therapy against destination-country labelling before tender submission.
Venclexta is supplied as film-coated tablets in 10 mg, 50 mg and 100 mg strengths, packaged for a fixed 5-week ramp-up schedule. Tablets are stored at or below 30C (86F), kept in the original container, and are not a cold-chain product.
Active ingredient
venetoclax. BCL-2 (B-cell lymphoma 2) inhibitor, selective apoptosis-restoring targeted oncology agent.
Forms and strengths
10 mg; 50 mg; 100 mg.
Indications
Oral BCL-2 inhibitor licensed for chronic lymphocytic leukaemia/small lymphocytic lymphoma and, in combination regimens, for newly diagnosed acute myeloid leukaemia in patients ineligible for intensive 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.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Hospital oncology pharmacies and NHS trust haematology units running CLL or AML protocols, MoH tender desks in the GCC and Africa procuring for public cancer centres, licensed wholesalers and importers stocking oral oncology lines, and NGO or humanitarian procurement bodies sourcing targeted haematology therapy for referral hospitals. Because venetoclax carries a mandatory TLS risk-assessment step before the first dose, buyers are typically tertiary or specialist oncology facilities rather than general pharmacy chains.
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 venetoclax.
Every venetoclax course, in both CLL/SLL and AML, starts with a 5-week dose ramp-up designed to reduce tumour burden gradually and cut tumour lysis syndrome (TLS) risk: 20 mg/day in week 1, 50 mg/day in week 2, 100 mg/day in week 3, 200 mg/day in week 4, then the target dose of 400 mg/day from week 5. AML regimens combined with a hypomethylating agent or low-dose cytarabine use a shorter 3- to 4-day ramp-up to the target dose; confirm the specific schedule against the combination regimen being tendered, since AML and CLL ramp-ups differ.
Tumour lysis syndrome is the dose-limiting risk. Changes in blood chemistry consistent with TLS can appear as early as 6 to 8 hours after the first dose and again at each dose increase through the ramp-up. Patients need a pre-dose TLS risk assessment (tumour burden, renal function), prophylactic hydration and anti-hyperuricaemic therapy before the first dose, and blood chemistry monitoring at each ramp-up step per the label's risk-tiered schedule.
Venclexta tablets are swallowed whole with food at approximately the same time each day; they are not to be chewed, crushed or broken outside specific circumstances described in the label. Grapefruit, Seville oranges and starfruit are contraindicated with venetoclax because of CYP3A interaction, and strong or moderate CYP3A inhibitors require dose reductions during ramp-up or hold decisions; procurement teams supporting therapy initiation should flag this to prescribing pharmacists.
Storage is room temperature, not cold chain: at or below 30C (86F), in the original container. This simplifies logistics into markets without validated cold-chain lanes but does not reduce the clinical monitoring burden around the ramp-up itself.
The documentation pack a regulator actually asks for.
Venetoclax moves through M Care's documentation chain as an ambient oral solid, not a biologic: CTD/eCTD-format dossiers, batch certificates of analysis, and import-licence-matched labelling are prepared for each destination market, without the temperature-excursion logging that a cold-chain biologic requires. As a merchant exporter M Care does not hold WHO-GMP or WHO-PQ certification itself and does not manufacture; product moves through WHO-GMP and, where applicable, EU-GMP-capable partner sites and licensed Indian distribution channels for this originator brand.
An FDA-approved generic version of venetoclax exists (Dr. Reddy's Laboratories, approved May 2026), but Venclexta's remaining US patents and regulatory exclusivity are expected to keep it off the market for several years; independent patent trackers put the earliest likely US generic launch around 2033. No generic or biosimilar venetoclax is commercially available today in the US, EU or other major destination markets M Care serves, so originator (AbbVie) supply remains the practical option for buyers. As venetoclax is a small-molecule oral tablet rather than a biologic, the applicable pathway for a copy product is a generic approval, not a biosimilar one. M Care tracks patent and generic-launch status across served markets and will update this position as it changes.
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 venetoclax.
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 venetoclax.
- 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.
Venetoclax supply, the specific questions.
Does a generic version of venetoclax exist?
An FDA-approved generic (Dr. Reddy's Laboratories, approved May 2026) exists, but Venclexta's remaining patents and regulatory exclusivity are expected to delay commercial launch by several years, with independent patent trackers estimating the earliest US market entry around 2033. No generic is commercially available today in the US, EU or other major destination markets, so supply in practice runs through licensed originator (AbbVie) distribution channels. M Care will update this position as generic availability changes.
Does Venclexta need cold-chain shipping?
No. Venetoclax tablets are stored and shipped at or below 30C (86F) in the original container. It does not require the temperature-monitored cold chain that biologic oncology products need.
Can M Care supply Venclexta to our market?
M Care sources Venclexta through licensed Indian distribution channels as a merchant exporter and quotes against your specific import licence, destination country and required pack count. Share your MoH or import authorisation and the Mumbai desk will confirm availability and lead time.
What indications is Venclexta licensed for?
Under FDA labelling, Venclexta is indicated for CLL/SLL (as monotherapy or combined with obinutuzumab, rituximab or, since February 2026, acalabrutinib in defined settings) and, combined with a hypomethylating agent or low-dose cytarabine, for newly diagnosed AML in adults unsuitable for intensive chemotherapy. EMA's Venclyxto label covers equivalent CLL and AML combination indications; confirm the approved combination and line of therapy against your destination country's labelling.
What monitoring does a hospital need before dispensing the first dose?
A pre-dose tumour lysis syndrome (TLS) risk assessment covering tumour burden and renal function, plus prophylactic hydration and anti-hyperuricaemic therapy. Blood chemistry is monitored at treatment start and at each dose increase through the 5-week (CLL/SLL) or 3- to 4-day (AML combination) ramp-up.
What tablet strengths does Venclexta come in?
10 mg, 50 mg and 100 mg film-coated tablets, packaged to match the fixed ramp-up dosing schedule from 20 mg/day up to the 400 mg/day target dose.
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.
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.