Ofev (nintedanib) is an oral antifibrotic capsule taken twice daily with food for idiopathic pulmonary fibrosis and other progressive fibrosing lung diseases, and it is bought as originator Ofev or as a registered generic depending on the destination.
M Care Exports supplies Ofev (nintedanib), made by Boehringer Ingelheim, and Indian-made nintedanib capsules, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Ofev 100 mg or 150 mg, tell us the destination and the registration route, and we quote the originator or a version your regulator accepts.
Also marketed as Vargatef.
Nintedanib exporter and bulk supplier from India.
"We need a partner for nintedanib" is a typical importer enquiry, usually from a respiratory or pulmonology formulary. M Care is a merchant-exporter: we quote originator Ofev and Indian-made lines (for example Nintena, Nintib and Nindanib) against your specification. The quote depends on originator or Indian-made, strength, pack type (blister or bottle), quantity and what your regulator will register. Indian-made lines are offered only for destinations whose registration accepts them, and we do not claim any of these brands is registered in a given country. Nintedanib is a room-temperature capsule, so the logistics question is moisture protection and remaining shelf life at arrival, not a temperature lane.
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.
Tyrosine kinase inhibitor, antifibrotic, sourced and documented for export.
Nintedanib is a tyrosine kinase inhibitor, supplied as nintedanib esilate in soft capsules. Per the FDA label, Ofev is indicated for idiopathic pulmonary fibrosis (IPF), for chronic fibrosing interstitial lung diseases with a progressive phenotype, and to slow the rate of decline in pulmonary function in systemic sclerosis-associated interstitial lung disease (SSc-ILD). The EU SmPC covers the same adult uses and extends to children and adolescents aged 6 to 17 for progressive fibrosing ILDs and to patients aged 6 and over for SSc-ILD, so labelling differs by region. The adult dose is 150 mg twice daily about 12 hours apart with food, and 100 mg twice daily is the reduced dose. Capsules come in 100 mg and 150 mg, and the EU SmPC also lists a 25 mg capsule, used in its weight-based paediatric dosing table. In the EU the same molecule is also authorised as Vargatef, an oncology product used with docetaxel for adenocarcinoma non-small cell lung cancer after first-line chemotherapy, per the EMA. Vargatef is a separate EU product with its own indication, not an alternative name for Ofev.
Active ingredient
Nintedanib esilate. Tyrosine kinase inhibitor, antifibrotic.
Forms and strengths
100 mg soft capsule; 150 mg soft capsule.
Indications
Nintedanib is an oral tyrosine kinase inhibitor, marketed as Ofev for idiopathic pulmonary fibrosis and progressive fibrosing interstitial lung diseases. Dosed twice daily with food.
Administration
Oral. Soft capsule.
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 pharmacists and respiratory or rheumatology formulary leads, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Ofev 150 mg" or "We need a partner for nintedanib capsules for a tender". Per the EU SmPC, treatment is started by physicians experienced in these lung diseases, and the capsules are taken by mouth twice daily, so volume buyers care about continuity of supply, pack type and shelf life at delivery. Each destination has its own registration 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.
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 nintedanib.
Four points matter at the counter. First, dosing: both the US label and the EU SmPC give 150 mg twice daily about 12 hours apart, with 100 mg twice daily as the reduced dose after adverse reactions. Mild hepatic impairment (Child-Pugh A) takes 100 mg twice daily, and moderate or severe impairment is not recommended. Second, liver tests: both documents call for checks before starting and during the early months, with drug-induced liver injury reported, including severe cases with fatal outcome. Third, tolerability: diarrhoea, nausea and vomiting are common, and the label advises treatment at first signs with adequate hydration. Fourth, handling: capsules are swallowed whole with food, not chewed, opened or crushed, and hands are washed if the contents touch the skin. Nintedanib can cause foetal harm, so highly effective contraception is advised during treatment and for at least 3 months after the last dose. Per the EU SmPC, treatment is initiated by physicians experienced in managing these diseases.
The documentation pack a regulator actually asks for.
Nintedanib needs no cold chain. The EU SmPC says do not store above 25°C and protect from moisture, in the original blister or in a tightly closed bottle, with a shelf life of 3 years for the 100 mg and 150 mg capsules. The US label sets storage at 20 to 25°C with excursions to 15 to 30°C and asks for protection from high humidity. For a bulk order that means checking remaining shelf life on arrival and keeping stock sealed in original packs. The EU marketing authorisation holder for Ofev is Boehringer Ingelheim International GmbH, authorised on 14 January 2015 per the EMA. For generics, the EMA lists Nintedanib Accord as a generic of Ofev, authorised on 19 April 2024, and DailyMed carries multiple generic nintedanib capsule labels beside the Ofev label. M Care documentation covers batch certificates of analysis, CDSCO export documents and destination-aligned dossier support where the regulator requires it. The manufacturer's WHO-GMP status is confirmed per line before quoting.
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 nintedanib.
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 nintedanib.
- 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.
Nintedanib supply, the specific questions.
What is the Ofev price, and what sets it for an importer?
We do not publish an Ofev price, because the landed cost depends on the destination. The main drivers are originator Ofev or an Indian-made line, strength (100 mg or 150 mg) and pack type, order quantity, the registration route in your country, shelf life required at arrival, and the Incoterms. Nintedanib needs no cold chain, which removes one cost line that biologics carry. M Care Exports quotes per destination. Send the strength, quantity and port, and we return an offer.
Is there a generic Ofev, and what is the situation in the US, EU and India?
Yes in the US and EU. DailyMed lists several generic nintedanib capsule labels beside the Boehringer Ingelheim Ofev label. In the EU, the EMA lists Nintedanib Accord as a generic of Ofev, authorised on 19 April 2024. For India, we cite no Indian regulator page here; what we can say is that Indian-made nintedanib lines (for example Nintena and Nintib) are on the M Care supplier roster for destinations whose registration accepts them. We do not claim any of these brands is registered in a given destination.
What is the difference between Ofev 100 mg and Ofev 150 mg?
Both are soft capsules of the same molecule. The label dose is 150 mg twice daily about 12 hours apart with food. The 100 mg capsule is the reduced dose, used after adverse reactions or in mild hepatic impairment (Child-Pugh A), per the US label and EU SmPC. The EU SmPC also lists a 25 mg capsule, used in its weight-based paediatric dosing table. Dosing is the prescriber's decision, and we supply to the destination's label. Tell us which strengths your tender specifies.
What is Ofev used for, and what are the 150 mg capsules for?
Per the FDA label, Ofev is indicated for idiopathic pulmonary fibrosis, for chronic fibrosing interstitial lung diseases with a progressive phenotype, and to slow the decline in lung function in systemic sclerosis-associated ILD. The EU SmPC adds paediatric use from age 6 for progressive fibrosing ILDs and SSc-ILD. The 150 mg capsule is the standard adult dose strength for all of these uses. Labelling differs by country, so we confirm the destination label before quoting.
What are the side effects of Ofev that a pharmacy should know about?
The US label lists diarrhoea, nausea, abdominal pain and vomiting as the most common adverse reactions, with treatment at first signs using adequate hydration advised. It also warns of elevated liver enzymes and drug-induced liver injury, embryo-fetal toxicity, arterial thromboembolic events, bleeding risk, gastrointestinal perforation and nephrotic range proteinuria. The US label has no boxed warning. This is not a substitute for the full prescribing information, which the prescriber and dispensing pharmacist should read for the destination's version.
What is the generic name of Ofev?
The generic (non-proprietary) name of Ofev is nintedanib, supplied as nintedanib esilate in the EU SmPC. Vargatef contains the same active substance but is a separate EU oncology product, authorised with docetaxel for adenocarcinoma non-small cell lung cancer after first-line chemotherapy. If your tender is written by molecule, send the wording and we quote nintedanib as originator Ofev or as an Indian-made line where your regulator accepts it.
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.
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