Lorviqua and Lorbrena are the EU/UK and US names for Pfizer's lorlatinib, an ALK tyrosine kinase inhibitor for ALK-positive non-small cell lung cancer, supplied as 25 mg and 100 mg film-coated tablets and dosed at 100 mg once daily.
M Care Exports supplies Lorviqua and Lorbrena (lorlatinib), the Pfizer ALK inhibitor, to oncology pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for lorlatinib 100 mg or 25 mg tablets, send the destination, the strength and the quantity, and we quote per destination.
Lorlatinib exporter and bulk supplier from India.
"We need a partner for Lorviqua" is a typical enquiry from a hospital oncology pharmacy or a tender desk, and "I'm looking for Lorbrena" is the same request under the US name. M Care is a merchant-exporter: we quote the originator product against your specification and confirm which strength and pack your destination registers. The labels set dose reductions at 75 mg and 50 mg once daily and say tablets must not be split, and both reduced doses are multiples of the 25 mg strength, so a formulary often needs both strengths. The US label stores lorlatinib at controlled room temperature and the UK SmPC sets no special storage conditions, so there is no cold-chain lane to price. The quote turns on strength, pack, quantity and the registration route in the destination. If you also stock EGFR therapy, our osimertinib page covers that lane separately.
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.
ALK tyrosine kinase inhibitor, antineoplastic, sourced and documented for export.
Lorlatinib is a kinase inhibitor sold as Lorbrena in the US and as Lorviqua in the EU and UK. The US label (Pfizer, revised January 2026) lists one indication: adults with metastatic non-small cell lung cancer (NSCLC) whose tumours are ALK-positive, as detected by an FDA-approved test. The EMA page for Lorviqua lists monotherapy in adults with advanced ALK-positive NSCLC in three settings: no prior ALK inhibitor, progression after alectinib or ceritinib as the first ALK inhibitor, or progression after crizotinib plus at least one other ALK inhibitor. The UK SmPC lists monotherapy in adults with ALK-positive advanced NSCLC not previously treated with an ALK inhibitor or whose disease has progressed after prior treatment with an ALK inhibitor. The US label describes a 25 mg tan round film-coated tablet and a 100 mg lavender oval film-coated tablet, supplied in bottles of 30 (25 mg and 100 mg) or 120 (25 mg). The UK SmPCs describe light pink 25 mg and dark pink 100 mg tablets in blister packs of 90 (25 mg) and 30 (100 mg), and note that not all pack sizes may be marketed.
Active ingredient
Lorlatinib. ALK tyrosine kinase inhibitor, antineoplastic.
Forms and strengths
25 mg film-coated tablet; 100 mg film-coated tablet.
Indications
Lorlatinib is an ALK tyrosine kinase inhibitor for adults with ALK-positive non-small cell lung cancer, marketed by Pfizer as Lorbrena in the US and Lorviqua in the EU and UK. Supplied to regulated and semi-regulated markets by M Care Exports.
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.
Buyers are hospital oncology pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Lorviqua 100 mg" or "We need a partner for lorlatinib for a cancer-centre tender". Each destination has its own route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. Where a product is not registered in a destination, the route to import depends on that regulator and we confirm it per enquiry. The labels give lorlatinib once daily for as long as the patient benefits without unacceptable toxicity, so a tender quote should set out a quantity plan across the year, with the 25 mg strength planned for dose reductions.
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 lorlatinib.
The recommended dose in the US and UK labels is 100 mg orally once daily, with or without food, swallowed whole. Dose reductions are 75 mg, then 50 mg once daily, which is why the 25 mg tablet matters on a formulary. The US label gives 50 mg daily for severe hepatic impairment (Child-Pugh C) and 75 mg daily for creatinine clearance of 15 to under 30 mL/min. The labels require monitoring. The US label has warnings for central nervous system effects, hyperlipidaemia, atrioventricular block, interstitial lung disease or pneumonitis, hypertension and hyperglycaemia, plus embryo-fetal toxicity. The UK SmPC adds decreased left ventricular ejection fraction and elevated pancreatic enzymes, and gives lipids before starting and at 2, 4 and 8 weeks, ECG before starting and monthly, blood pressure after 2 weeks and at least monthly, and fasting glucose before starting and periodically. Concomitant strong CYP3A inducers are contraindicated in both labels, and the US label cites serious hepatotoxicity. Check the patient's medicine list before dispensing.
The documentation pack a regulator actually asks for.
The US label stores lorlatinib at 20 to 25 °C, with excursions permitted from 15 to 30 °C. The UK SmPC states that no special storage conditions are required and gives a shelf life of 3 years. The UK marketing authorisation holder is Pfizer Limited and the first UK authorisation date shown is 6 May 2019. The EMA page lists Pfizer Europe MA EEIG as the EU holder and states that Lorviqua received a conditional marketing authorisation valid throughout the EU on 6 May 2019; the page was last updated on 3 July 2026. The US label names Pfizer Laboratories Div Pfizer Inc, and Drugs@FDA lists both strengths under Pfizer's NDA 210868 as prescription products. The US label we read carries no boxed warning. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it, and makes no claim for M Care itself beyond merchant-exporter documentation.
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 lorlatinib.
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 lorlatinib.
- 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.
Lorlatinib supply, the specific questions.
What decides the landed price of Lorviqua or Lorbrena for an importer?
We do not publish prices. The landed cost depends on the strength (100 mg or 25 mg), the pack, the quantity, whether the line is the originator product, the registration route in your destination and Incoterms. Lorlatinib needs no cold chain on the US and UK labels we read, so freight is simpler than for biologicals. M Care Exports quotes per destination once you send the strength, volume and country.
What is the lorlatinib brand name, Lorviqua or Lorbrena?
Both names cover the same active substance, lorlatinib, from Pfizer. Lorbrena is the name on the US label. Lorviqua is the name on the EMA and UK emc listings. Both come as 25 mg and 100 mg film-coated tablets, though tablet colour and pack counts differ between the US and UK labels. Which name and pack you can import depends on what your destination registers, and we confirm that before quoting.
Is there a Lorbrena generic or a generic lorlatinib?
We found no approved generic lorlatinib in the US, EU or UK sources we checked. Drugs@FDA lists only Pfizer's Lorbrena application, the EMA page for Lorviqua does not mention a generic, and the UK emc lists only Pfizer's Lorviqua tablets. Patent position is a legal matter that changes, so we do not rely on it for supply. If you are looking for lorlatinib, M Care Exports confirms what is available per destination before quoting.
What is the lorlatinib dose?
The recommended dose in the US label and the UK SmPC is 100 mg taken orally once daily. Dose reductions for adverse reactions are 75 mg, then 50 mg once daily. The US label also gives 50 mg daily for severe hepatic impairment and 75 mg daily for creatinine clearance of 15 to under 30 mL/min. The prescriber sets the dose, and the label of your destination governs use.
What are the main lorlatinib side-effect warnings in the label?
The US label lists central nervous system effects, hyperlipidaemia, atrioventricular block, interstitial lung disease or pneumonitis, hypertension and hyperglycaemia, plus serious hepatotoxicity with strong CYP3A inducers and embryo-fetal toxicity. Strong CYP3A inducers are contraindicated. The UK SmPC sets monitoring of lipids, ECG, blood pressure and glucose. Full adverse-reaction detail is in the current label, and clinical questions belong with the prescriber.
What is the difference between Lorviqua 25 mg and 100 mg, and does it need a cold chain?
Both are lorlatinib film-coated tablets in different strengths. The 100 mg tablet is the standard once-daily dose. The labels set dose reductions at 75 mg and 50 mg and say tablets must not be split, so those doses are made up from 25 mg tablets. Neither needs refrigeration: the US label gives 20 to 25 °C and the UK SmPC requires no special storage, with a 3-year shelf life. Pack counts differ between the US bottles and the UK blister packs, so tell us the pack your destination registers.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.