Tecentriq (atezolizumab) is a PD-L1 checkpoint inhibitor with FDA and EMA approvals across lung, liver, skin and other solid tumours, and every vial moves as a 2-8C cold-chain biologic from first mile to last.
Tecentriq (atezolizumab) is Genentech's PD-L1 checkpoint inhibitor, licensed across non-small cell and small cell lung cancer, hepatocellular carcinoma and other solid tumours depending on destination-market labelling. M Care sources it through licensed Indian distribution channels as a merchant exporter, not a manufacturer, and moves it as a validated cold-chain biologic to hospital pharmacies, tender desks and importers across our 49 markets.
Atezolizumab exporter and bulk supplier from India.
For MoH tenders, NGO procurement (Global Fund, UNICEF, MSF, CHAI-linked buyers) and multi-site hospital group orders, the Mumbai desk quotes Tecentriq against a firm delivery schedule and a validated cold-chain lane, not a spot price list. Because atezolizumab is a patented biologic, supply runs through Genentech's licensed Indian distribution network rather than generic manufacturing, so lead times are set by allocation and import documentation rather than production capacity. We handle CTD/eCTD-aligned dossier support, batch-level cold-chain records and destination import paperwork as part of the same order, and can structure phased dispatch against a tender delivery calendar.
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.
PD-L1 (programmed death-ligand 1) blocking humanised monoclonal antibody, checkpoint inhibitor, sourced and documented for export.
Atezolizumab is a humanised monoclonal antibody that binds PD-L1, blocking its interaction with PD-1 and B7.1 receptors on T cells. This restores T-cell-mediated anti-tumour activity that PD-L1 expression on tumour or tumour-infiltrating immune cells would otherwise suppress.
Under the FDA label, Tecentriq monotherapy is indicated for metastatic NSCLC after progression on platinum-based chemotherapy (and after targeted therapy in EGFR/ALK-aberrant disease), and in combination with carboplatin and etoposide for first-line extensive-stage small cell lung cancer, with a lurbinectedin-combination maintenance option after induction. It is also FDA-approved in combination with bevacizumab for unresectable or metastatic hepatocellular carcinoma with no prior systemic treatment. Under the EMA SmPC, licensed indications include locally advanced or metastatic urothelial carcinoma after platinum chemotherapy or in cisplatin-ineligible patients with PD-L1 expression 5% or higher, first-line metastatic non-squamous NSCLC in combination with bevacizumab, paclitaxel and carboplatin, and NSCLC monotherapy after prior chemotherapy. Other licensed indications apply per destination-country labelling, so we confirm the exact indication set against the importing market's approved SmPC or label before dossier submission.
Tecentriq is supplied as a concentrate for solution for infusion in single-dose vials, administered intravenously by infusion, never as a bolus injection. (A separate co-formulation with hyaluronidase, marketed as Tecentriq Hybreza in the US and Tecentriq SC in the EU, is approved for subcutaneous administration in some markets; this is a distinct product from the IV vials covered here.) It is a refrigerated biologic requiring storage at 2-8C in the original carton, protected from light, and must never be frozen or shaken. Every M Care lane for this product runs on validated cold-chain logistics with temperature logging from dispatch to destination pharmacy.
Active ingredient
atezolizumab. PD-L1 (programmed death-ligand 1) blocking humanised monoclonal antibody, checkpoint inhibitor.
Forms and strengths
840 mg/14 mL vial; 1200 mg/20 mL vial.
Indications
PD-L1 checkpoint inhibitor licensed for NSCLC, small cell lung cancer and hepatocellular carcinoma under the FDA label, with additional EMA-approved indications including urothelial carcinoma and triple-negative breast cancer; the exact indication set depends on destination-country registration.
Administration
intravenous. Concentrate for solution for infusion, single-dose vial.
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 Tecentriq through the Mumbai desk are typically oncology-centre hospital pharmacies, MoH cancer-treatment tender desks in GCC and African markets, licensed importers and wholesalers holding the destination country's oncology-biologic import permit, and NGO or donor-funded procurement bodies sourcing for public cancer programmes. Because it is a refrigerated IV biologic under patent, every buyer needs a validated cold-chain receiving capability and the correct import licence for a specialty oncology biologic before we confirm an order.
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 atezolizumab.
Dose selection depends on the destination label and indication. Both the FDA label and the EMA SmPC list three interchangeable fixed-dose IV regimens: 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks, with the choice set by the accompanying treatment protocol. Confirm which schedule the prescribing protocol specifies before dispensing, since combination regimens (with bevacizumab, with carboplatin/etoposide, with paclitaxel/carboplatin/bevacizumab) each anchor to a specific cycle length.
This IV formulation is given by infusion only; a separate subcutaneous co-formulation (Tecentriq Hybreza, with hyaluronidase-tqjs) is approved in some markets but is a distinct product not covered by this listing. The first IV infusion is given over 60 minutes; if tolerated without an infusion-related reaction, every subsequent infusion may be shortened to 30 minutes. No dose reduction for atezolizumab itself is recommended on either label; toxicity is managed by interruption or discontinuation, not dose-splitting.
Vials must stay at 2-8C from the moment they leave the cold store, in the original carton, protected from light, never frozen and never shaken. Reconstituted infusion bags have their own use-in-use window per the label; hospital pharmacy should verify the current in-use stability window against the label version supplied with each batch rather than assume it is unchanged release to release.
As with any PD-L1/PD-1 checkpoint inhibitor, monitor for immune-mediated adverse reactions, pneumonitis, hepatitis, colitis, endocrinopathies and infusion-related reactions, per the label's dedicated warnings section. There is no licensed biosimilar to atezolizumab in any major market; every unit dispensed is originator Tecentriq.
The documentation pack a regulator actually asks for.
Atezolizumab moves through the same documentation chain as any refrigerated oncology biologic: batch release documentation from the originator's licensed distribution channel, cold-chain temperature logs covering the full transit, and CTD/eCTD-format dossier support for destination-country registration or import-licence renewal. M Care sources WHO-GMP-aligned product through licensed Indian channels and holds CDSCO export licensure; we do not hold WHO-GMP or WHO-PQ status ourselves and do not manufacture atezolizumab or any product we export.
Tecentriq remains under patent protection and there is no FDA-licensed or EMA-authorised biosimilar to atezolizumab at present. Buyers sourcing this molecule are sourcing originator brand only; there is no generic or biosimilar substitution choice to present. Because supply runs through Genentech's licensed distribution network rather than open generic manufacturing, allocation and batch traceability documentation matter more than they do for a generic oncology molecule, and we build that into the tender submission from the outset.
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 atezolizumab.
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 atezolizumab.
- 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.
Atezolizumab supply, the specific questions.
Is there a generic or biosimilar version of Tecentriq (atezolizumab)?
No. Atezolizumab is still under patent protection and there is no FDA-licensed or EMA-authorised biosimilar on the market. Every unit M Care supplies is originator Tecentriq sourced through Genentech's licensed Indian distribution channels, not a generic manufacturer.
How is Tecentriq stored and shipped, and can M Care guarantee cold chain to my market?
Tecentriq must stay at 2-8C in its original carton, protected from light, from the moment it leaves cold storage until it reaches the hospital pharmacy. M Care runs validated cold-chain lanes with temperature logging across our export markets and builds the logistics plan around this product's storage requirement before quoting a delivery schedule.
Can M Care supply Tecentriq to my country?
M Care exports on an import basis: we supply against your country's import licence and registration status for this product, not as a domestic seller. Tell us the destination market and buyer type (hospital, MoH tender, importer) and the Mumbai desk will confirm the import route and documentation needed.
What indications is Tecentriq licensed for?
Licensed indications vary by regulator. Under the FDA label they include metastatic NSCLC after platinum chemotherapy, first-line extensive-stage small cell lung cancer in combination with chemotherapy, and hepatocellular carcinoma in combination with bevacizumab. Under the EMA SmPC they include urothelial carcinoma, first-line non-squamous NSCLC in combination with bevacizumab/paclitaxel/carboplatin, and NSCLC monotherapy after prior chemotherapy. We confirm the exact indication set against the importing market's approved label before dossier submission.
Does M Care hold WHO-GMP or WHO-PQ status for this product?
No. M Care is a merchant exporter, not a manufacturer. We source atezolizumab through Genentech's licensed Indian distribution channels and hold CDSCO export licensure and ISO 9001:2015 certification; WHO-GMP and WHO-PQ status sits with the originator's manufacturing sites, not with M Care.
What dosing schedule does Tecentriq use?
Atezolizumab is dosed on one of three interchangeable IV schedules: 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks, per both the FDA label and the EMA SmPC. The first infusion runs over 60 minutes; later infusions may be shortened to 30 minutes if the first was tolerated. The prescribing protocol determines which schedule applies.
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.