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Details
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Specifications
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CAS Number
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656247-18-6
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Molecular Formula
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C33H39N5O7S
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Molecular Weight
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649.76 g/mol.
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Synonyms
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Nintedanib ethanesulfonate
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Chemical Name
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(Z)-methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl) acetamido) phenyl) amino) (phenyl) methylene)-2-oxoindoline-6-carboxylate ethane sulfonate
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Common name
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Nintedanib esylate
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Therapeutic use
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Idiopathic pulmonary fibrosis (IPF), Non-small-cell lung cancer
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Background
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Nintedanib was approved in March 2020 in the United States for use to treat chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first treatment for this group of fibrosing lung diseases that worsen over time that was approved by the U.S. Food and Drug Administration (FDA).
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Grade
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In-house
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Polymorph
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Form I
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GTI
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-
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Nitrosamines
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-
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DMF Availability
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-
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Manufacturing batch size
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-
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Production capacity
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-
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Stability data
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-
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*Â
Disclaimer:Â
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Nintedanib esylate is a triple angiokinase inhibitor, an oral small-molecule active pharmaceutical ingredient (API) used mainly to treat progressive scarring diseases of the lung. It blocks three growth-factor receptor families that drive tissue scarring and abnormal blood-vessel growth, which helps slow the progression of lung fibrosis. The reference brands are Ofev and Vargatef, and Nintedanib is one of the leading molecules in the fast-growing interstitial lung disease (ILD) market.
Shilpa Pharma is a trusted Nintedanib esylate API manufacturer and supplier in India, producing this molecule at cGMP-compliant, globally audited facilities. Backed by strong process chemistry and specialty API expertise, Shilpa Pharma supports generic developers and innovator companies with high-purity Nintedanib esylate API and full documentation support.
Key specifications
As a science-led pharmaceutical API manufacturer in India, Shilpa Pharma combines strong process chemistry, tight quality control, and world-class API manufacturing in India to deliver Nintedanib esylate that meets demanding international standards.
Nintedanib esylate API is used to manufacture prescription medicines for fibrotic lung diseases and certain cancers. Approved uses of Nintedanib-based drugs include idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases with a progressive phenotype (progressive pulmonary fibrosis), and systemic sclerosis-associated interstitial lung disease (SSc-ILD). In the European Union, Nintedanib is also used, in combination with docetaxel, to treat certain types of advanced non-small cell lung cancer (NSCLC).
The molecule belongs to the tyrosine kinase inhibitor class and is often called a triple angiokinase inhibitor. In simple terms, it blocks three families of growth-factor receptors (VEGFR, FGFR, and PDGFR) that signal cells to form scar tissue and new blood vessels. By calming these signals, Nintedanib slows the build-up of fibrosis in the lungs and limits the blood supply that tumours need to grow.
For formulation, Nintedanib esylate is developed as an oral soft capsule, commonly in 100 mg and 150 mg strengths taken twice daily. Shilpa Pharma supplies Nintedanib esylate API with controlled particle size and consistent solid-state quality to support stable, reproducible formulation development, and offers related API intermediates and integrated CDMO services for scale-up and commercial supply.
Nintedanib is a potent kinase inhibitor, so it must be handled with the right safety controls during manufacturing. Shilpa Pharma produces Nintedanib esylate API under controlled cGMP conditions, using trained personnel, containment systems, and protective measures that safeguard both product quality and operator safety. These are the same disciplined standards Shilpa Pharma applies across its specialty and potent API work.
On product safety, Shilpa Pharma places strong focus on impurity control and full analytical characterisation. Sensitive analytical methods keep impurities, including any genotoxic impurities, within safe, regulator-approved limits, and every batch is supported by complete quality and stability documentation.
From a clinical reference point, Nintedanib medicines carry important prescribing precautions. The most common effect is diarrhoea, and prescribers also monitor for liver enzyme changes, bleeding and clotting risks, and embryo-foetal toxicity, which means the drug can harm an unborn baby. This information is shared only as scientific reference for drug developers and is not medical advice.
Shilpa Pharma supplies Nintedanib esylate API strictly to licensed pharmaceutical manufacturers, biotech firms, and authorised partners, with full documentation to support safe and compliant use in finished drug products.
Nintedanib esylate API pricing is shared on request. Because API cost depends on order volume, delivery timelines, target market, and regulatory requirements, Shilpa Pharma provides a customised quotation for every enquiry rather than a fixed list price.
To receive current Nintedanib esylate API pricing, availability, and documentation (including DMF status and technical data), please contact the Shilpa Pharma team. Minimum order quantities apply, and Shilpa Pharma partners exclusively with pharmaceutical manufacturers, biotech companies, and authorised trading firms.
Email: info@shilpapharma.com | Request a Quote
Choosing the right Nintedanib esylate API supplier means choosing quality, compliance, and reliability. Here is why global pharmaceutical companies trust Shilpa Pharma:
With decades of proven expertise and world-class API manufacturing in India, Shilpa Pharma is the partner of choice for companies developing advanced therapies for lung fibrosis and interstitial lung disease. For a single-source Nintedanib esylate API supplier or a long-term manufacturing partner, Shilpa Pharma delivers integrity, quality, and global performance.
Partner with a trusted Nintedanib esylate manufacturer in India. Contact Shilpa Pharma today.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
