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Nintedanib API Manufacturers & Suppliers

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Commercial-scale Suppliers

Producer
Produced in  India
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Employees: 5000+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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ISO9001
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CoA

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GMP
FDA
ISO9001
CoA
Producer
Produced in  Czech Republic
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: CoA

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CoA
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Producer
Produced in  India
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Employees: 19

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CoA

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GMP
FDA
CoA
Distributor
Produced in  India
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Employees: 25

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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ISO9001

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GMP
FDA
MSDS
BSE/TSE
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CoA
Producer
Produced in  Taiwan
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Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
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CoA

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USDMF
CoA
Producer
Produced in  India
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Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
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CoA

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USDMF
CoA
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Producer
Produced in  India
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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CoA

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USDMF
CoA
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Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
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CoA

All certificates

USDMF
CoA
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Nintedanib | CAS No: 656247-17-5 | GMP-certified suppliers

A medication that treats idiopathic pulmonary fibrosis and other progressive interstitial lung diseases and supports therapy for previously treated adenocarcinoma‑type non‑small cell lung cancer.

Therapeutic categories

Antifibrotic AgentsAntineoplastic AgentsAntineoplastic and Immunomodulating AgentsCytochrome P-450 CYP3A SubstratesCytochrome P-450 CYP3A4 SubstratesCytochrome P-450 CYP3A4 Substrates (strength unknown)
Generic name
Nintedanib
Molecule type
small molecule
CAS number
656247-17-5
DrugBank ID
DB09079
Approval status
Approved drug
ATC code
L01EX09

Primary indications

  • Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease
  • It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype
  • In the EU, under the brand name Vargatef, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy

Product Snapshot

  • Oral small‑molecule tyrosine kinase inhibitor supplied as capsules
  • Used for idiopathic pulmonary fibrosis, systemic‑sclerosis associated interstitial lung disease, other chronic fibrosing ILDs with a progressive phenotype, and in the EU for combination use in certain previously treated adenocarcinoma NSCLC settings
  • Approved in the US, EU, and Canada

Clinical Overview

Nintedanib (CAS 656247-17-5) is an indolecarboxylic acid derivative and orally administered small molecule kinase inhibitor indicated for idiopathic pulmonary fibrosis, systemic‑sclerosis associated interstitial lung disease, and chronic fibrosing interstitial lung diseases with a progressive phenotype. In oncology, it is approved in the European Union under the brand Vargatef for use with docetaxel in adults with metastatic, locally advanced, or locally recurrent adenocarcinoma‑type non‑small cell lung cancer previously treated with first‑line therapy.

The pharmacological activity of nintedanib derives from competitive inhibition of receptor tyrosine kinases involved in fibrotic signaling and tumour angiogenesis. It targets PDGFR alpha and beta, FGFR 1–3, VEGFR 1–3, and FLT3, blocking ATP binding and reducing downstream proliferative and migratory signaling in lung fibroblasts. Additional inhibition of the non‑receptor tyrosine kinases Lck, Lyn, and Src further contributes to suppression of pathways implicated in fibrosis progression.

Pharmacodynamically, these actions slow structural lung decline in fibrotic disease and modulate endothelial and perivascular cell activity within tumour microenvironments. The compound is a substrate of CYP3A4, UGT1A1, OCT1, and P‑glycoprotein, and is also reported to inhibit OCT1 and P‑glycoprotein. These characteristics underscore the relevance of transporter and metabolic interactions, particularly in polypharmacy settings or when co‑administered with potent CYP3A4 modulators.

Nintedanib has a recognized risk of drug‑induced liver injury, especially during the first three months of treatment. Baseline and periodic liver function assessments are required. Use is not recommended in patients with moderate to severe hepatic impairment. Additional safety considerations include gastrointestinal adverse effects and potential bleeding risk, the latter relevant when combined with other agents affecting hemostasis.

For API procurement, suppliers should document impurity profiles, residual solvent controls, and stability data aligned with ICH expectations. Consistency in crystallinity, particle characteristics, and polymorph form is important to support reliable formulation performance and regulatory acceptance.

Identification & chemistry

Generic name Nintedanib
Molecule type Small molecule
CAS 656247-17-5
UNII G6HRD2P839
DrugBank ID DB09079

Pharmacology

SummaryNintedanib is a small‑molecule inhibitor of multiple receptor and non‑receptor tyrosine kinases that regulate pathways involved in fibrosis and angiogenesis. By blocking PDGFR, FGFR, VEGFR, FLT3, and selected Src‑family kinases, it suppresses fibroblast proliferation, migration, and pro‑angiogenic signalling. These combined effects underlie its use in fibrotic lung disease and certain oncology settings.
Mechanism of actionNintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis, so nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease.The specific RTKs that nintedanib inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, and Fns-Like tyrosine kinase-3 (FLT3).Nintedanib binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts. Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells. In addition to RTK inhibition, nintedanib also prevents the actions of the nRTKs Lck, Lyn, and Src.The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of nintedanib is unclear, but inhibition of the Src pathway by nintedanib has been shown to reduce lung fibrosis.
PharmacodynamicsNintedanib is a small molecule kinase inhibitor that inhibits upstream kinase activity to ultimately inhibit lung fibroblast proliferation and migration, as well as signalling pathways that promote the proliferation and survival of endothelial and perivascular cells in tumour tissues. Nintedanib poses a risk of drug-induced liver injury, especially within the first three months of therapy.Liver function tests should be conducted at baseline prior to beginning therapy, at regular intervals for the first three months of therapy, and as indicated thereafter in patients exhibiting symptoms of hepatic injury such as jaundice or right upper quadrant pain. It is not recommended to be used in patients with pre-existing moderate to severe hepatic impairment (Child Pugh class B or C).
Targets
TargetOrganismActions
Vascular endothelial growth factor receptor 1Humansinhibitor
Vascular endothelial growth factor receptor 2Humansinhibitor
Vascular endothelial growth factor receptor 3Humansinhibitor

ADME / PK

AbsorptionThe absolute bioavailability of nintedanib is low at approximately 4.7%, likely owing to substantial first-pass metabolism and the effects of p-glycoprotein (P-gp) transporters.T<sub>max</sub> following oral administration is reached after approximately 2 hours in fasted patients and approximately 4 hours in fed patients, regardless of the food consumed.Administration of nintedanib following a high-fat, high-calorie meal resulted in an increase in C<sub>max</sub> by approximately 15% and an increase in AUC by approximately 20%.Age, body weight, and smoking status have been found to alter exposure to nintedanib, but these effects are not significant enough to warrant dose alterations.
Half-lifeThe terminal elimination half-life of nintedanib is approximately 10-15 hours.In patients with idiopathic pulmonary fibrosis, the effective half-life of nintedanib has been estimated to be approximately 9.5 hours.
Protein bindingPlasma protein binding of nintedanib is high, with a bound fraction of 97.8%. Albumin is thought to be the major binding protein.
MetabolismNintedanib is predominantly metabolized via hydrolytic cleavage by esterases to its principle metabolite, BIBF 1202, which then undergoes glucuronidation via UGT enzymes in the intestines and liver (specifically UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10) to form BIBF 1202 glucuronide.The CYP450 enzyme system plays a minor role in nintedanib metabolism, with CYP3A4 believed to be the main contributor - the major CYP-dependent metabolite of nintedanib, a demethylated metabolite termed BIBF 1053, could not be detected in plasma during pharmacokinetic studies and was found only in small quantities in the feces (approximately 4% of total dose).CYP-dependent metabolism of nintedanib accounts for roughly 5% of total drug metabolism, as opposed to 25% for esterase cleavage.Other minor metabolites, M7 and M8, are found in very small quantities in the urine (0.03% and 0.01%, respectively), though their origin and relevance is currently unclear.
Route of eliminationNintedanib is eliminated primarily via fecal and biliary excretion, with 93.4% of radio labelled nintedanib found in feces within 120 hours following administration.Renal clearance accounts for a small portion of nintedanib's elimination, approximately 0.65% of the total dose, and excretion of unchanged nintedanib 48 hours after oral and intravenous doses was 0.05% and 1.4%, respectively.
Volume of distributionNintedanib appears to follow biphasic disposition kinetics - the observed volume of distribution following intravenous administration is 1050 L, indicating extensive distribution into peripheral tissues. In rats, nintedanib was shown to rapidly and homogeneously distribute into peripheral tissues with the exception of the CNS, suggestive of an inability of nintedanib to cross the blood-brain barrier.
ClearanceNintedanib is has a high total plasma clearance of approximately 1390 mL/min and a renal clearance of 20 mL/min.

Formulation & handling

  • Oral small‑molecule API with low aqueous solubility, typically formulated in soft‑gel or liquid‑filled capsules to support dissolution and consistent exposure.
  • Moderate lipophilicity (LogP ~2.8) and poor water solubility require solubilization approaches and protection from precipitation in gastric conditions.
  • Absorption is food‑dependent, so formulations should be designed to maintain performance under fed conditions and minimize variability.

Regulatory status

LifecycleThe API is in a mature phase in Canada, the US, and the EU, with several core U.S. patents already expired in 2024 and additional protections ending between 2026 and 2029. Remaining later‑expiring patents suggest a gradual shift toward broader generic competition as these protections lapse.
MarketsCanada, US, EU
Supply Chain
Supply chain summaryNintedanib is supplied by a single originator product alongside multiple generic-branded versions, indicating both innovator and non‑originator manufacturers in the market. Branded and generic presentations appear across the US, EU, and Canada, reflecting established global distribution. Several key US patents have recently expired, while others extend to 2026 and 2029, suggesting partial ongoing protection with existing or expanding generic competition in some markets.

Safety

ToxicityExperience with nintedanib overdose is limited, but patients who inadvertently received higher-than-intended doses during initial trials experienced adverse effects consistent with the known safety profile of nintedanib, for example elevated liver enzymes and significant gastrointestinal effects. There are no specific guidelines for the treatment of nintedanib overdose - in this case, therapy should be interrupted and general supportive measures employed as indicated.
High Level Warnings:
  • Overexposure has been associated with elevations in hepatic enzymes and pronounced gastrointestinal intolerance, reflecting the compound’s established safety profile
  • No compound‑specific remediation protocols are defined
  • Management in overdose settings relies on nonspecific supportive measures

Nintedanib is a type of Protein kinase inhibitors


Protein kinase inhibitors are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in targeted cancer therapies. These inhibitors specifically target and block the activity of protein kinases, enzymes that regulate various cellular processes, including cell growth, division, and signal transduction.

Protein kinase inhibitors function by binding to the active site of protein kinases, preventing them from phosphorylating specific proteins and disrupting intracellular signaling pathways. This targeted approach inhibits the uncontrolled growth and proliferation of cancer cells, ultimately leading to their death.

The development of protein kinase inhibitors has revolutionized cancer treatment by providing more effective and less toxic alternatives to traditional chemotherapy. These drugs have demonstrated impressive results in the treatment of various cancers, including lung, breast, and leukemia.

The pharmaceutical industry invests heavily in research and development to discover novel protein kinase inhibitors with improved potency, selectivity, and pharmacokinetic properties. High-throughput screening, computational modeling, and structure-activity relationship studies are employed to identify potential lead compounds.

The success of protein kinase inhibitors in treating cancer has spurred significant interest in this subcategory of APIs. Ongoing research aims to expand their applications to other diseases, such as autoimmune disorders and neurological conditions.

In conclusion, protein kinase inhibitors are a valuable class of pharmaceutical APIs with immense potential for targeted cancer therapies. Continued advancements in this field hold promise for improved treatment outcomes and enhanced patient care.


Nintedanib (Protein kinase inhibitors), classified under Anticancer drugs


Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.

Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.

These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.

Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.



Nintedanib API manufacturers & distributors

Compare qualified Nintedanib API suppliers worldwide. We currently have 8 companies offering Nintedanib API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
India India CoA, USDMF164 products
Producer
Taiwan Taiwan CoA, USDMF36 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
India India CoA, USDMF119 products
Producer
India India CoA, FDA, GMP515 products
Producer
India India CoA, FDA, GMP, ISO900154 products
Producer
India India CoA, USDMF219 products
Producer
Czech Republic Czech Republic CoA144 products

When sending a request, specify which Nintedanib API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Nintedanib API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

Frequently asked questions about Nintedanib API


Sourcing

What matters most when sourcing GMP-grade Nintedanib?
When sourcing GMP‑grade Nintedanib, ensure the manufacturer complies with applicable GMP and regulatory requirements for Canada, the US, and the EU. Confirm that the supplier’s quality documentation and regulatory status support use in these regions. Assess supply reliability given the presence of both originator and generic manufacturers and the ongoing but declining patent coverage through 2026 and 2029.
Which documents are typically required when sourcing Nintedanib API?
Request the core API documentation set: CoA (8 companies), USDMF (4 companies), GMP (3 companies), FDA (3 companies), ISO9001 (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Nintedanib API?
Known or reported manufacturers for Nintedanib: Global Pharma Tek, SETV Global, Veeprho Group, Shilpa Medicare Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Nintedanib API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Nintedanib manufacturers?
Audit reports may be requested for Nintedanib: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Nintedanib API on Pharmaoffer?
Reported supplier count for Nintedanib: 8 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Nintedanib API?
Production countries reported for Nintedanib: India (6 producers), Czech Republic (1 producer), Taiwan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Nintedanib usually hold?
Common certifications for Nintedanib suppliers: CoA (8 companies), USDMF (4 companies), GMP (3 companies), FDA (3 companies), ISO9001 (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Nintedanib (CAS 656247-17-5) used for?
Nintedanib is used to treat idiopathic pulmonary fibrosis, systemic‑sclerosis–associated interstitial lung disease, and other chronic fibrosing interstitial lung diseases with a progressive phenotype. In the European Union, it is also approved with docetaxel for adults with metastatic, locally advanced, or locally recurrent adenocarcinoma‑type non‑small cell lung cancer previously treated with first‑line therapy. Its therapeutic effects arise from inhibition of multiple receptor and non‑receptor tyrosine kinases involved in fibrotic signaling and tumour angiogenesis.
Which therapeutic class does Nintedanib fall into?
Nintedanib belongs to the following therapeutic categories: Antifibrotic Agents, Antineoplastic Agents, Antineoplastic and Immunomodulating Agents, Cytochrome P-450 CYP3A Substrates, Cytochrome P-450 CYP3A4 Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Nintedanib mainly prescribed for?
The primary indications for Nintedanib: Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease, It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype, In the EU, under the brand name Vargatef, Nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Nintedanib work?
Nintedanib is a small molecule, competitive, triple angiokinase inhibitor that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Many of these RTKs are implicated in lung fibrosis and tumour angiogenesis, so Nintedanib is therefore used in the treatment of proliferative diseases such as idiopathic pulmonary fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease.The specific RTKs that Nintedanib inhibits are platelet-derived growth factor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, and Fns-Like tyrosine kinase-3 (FLT3).Nintedanib binds to the ATP-binding pocket of these receptors and inhibits their activity, thereby blocking signalling cascades that result in the proliferation and migration of lung fibroblasts. Nintedanib also inhibits kinase signalling pathways in various cells within tumour tissues, including endothelial cells, pericytes, smooth muscle cells, and cells contributing to angiogenesis, culminating in an inhibition of cell proliferation and apoptosis of affected tumour cells. In addition to RTK inhibition, Nintedanib also prevents the actions of the nRTKs Lck, Lyn, and Src.The contribution of the inhibition of Lck and Lyn towards the therapeutic efficacy of Nintedanib is unclear, but inhibition of the Src pathway by Nintedanib has been shown to reduce lung fibrosis.
What should someone know about the safety or toxicity profile of Nintedanib?
Nintedanib’s safety profile is characterized by a recognized risk of drug‑induced liver injury, with elevations in hepatic enzymes most likely early in therapy, warranting baseline and periodic liver function monitoring and avoidance in moderate to severe hepatic impairment. Gastrointestinal intolerance is common and may be pronounced with overexposure. The drug can increase bleeding risk, which is relevant when used with other agents affecting hemostasis. In overdose, no compound‑specific measures exist, and management relies on nonspecific supportive care.
What are important formulation and handling considerations for Nintedanib as an API?
Nintedanib’s low aqueous solubility and moderate lipophilicity require solubilization strategies, commonly implemented through soft‑gel or liquid‑filled capsule systems that enhance dissolution and limit precipitation in gastric conditions. Formulations should maintain consistent performance under fed conditions because absorption increases with food. Handling should minimize moisture exposure and ensure uniform dispersion of the API within the fill matrix. The API’s high protein binding and extensive first‑pass metabolism do not directly alter formulation needs but reinforce the importance of achieving reliable oral absorption.
Is Nintedanib a small molecule?
Nintedanib is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Nintedanib?
Yes. Its low aqueous solubility and moderate lipophilicity require protection against precipitation and support for adequate dissolution, which is why it is commonly delivered in soft‑gel or liquid‑filled capsules. The API should be formulated to maintain performance under fed conditions, as absorption is food‑dependent and variability can arise if dissolution changes with gastric contents. Stability considerations therefore focus on maintaining the solubilized state and preventing changes that could reduce exposure.

Regulatory

Where is Nintedanib approved or in use globally?
Nintedanib is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Nintedanib right now?
Nintedanib is authorized for use in Canada, the United States, and the European Union. Its regulatory status in these regions reflects established review and approval pathways. Patent considerations vary by jurisdiction and proceed independently of these regulatory decisions.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Nintedanib procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Nintedanib. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Nintedanib included in the PRO Data Insights coverage?
PRO Data Insights coverage for Nintedanib: 372 verified transactions across 144 suppliers and 80 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Nintedanib?
Market report availability for Nintedanib: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.