nintedanib Oral suspension 50 mg/ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #31060
This company is a contract development and manufacturing organization (CDMO) specializing in the production of high-potency and oncological oral liquid formulations. Established in recent years, the company operates primarily in the European Union and North America. Their core expertise lies in developing and manufacturing customized, high-quality, and cost-effective oral liquid products for patients requiring dose titration and tailored treatment plans. Their production lines focus on oncology, specifically targeting high-potency medications for oral administration. This CDMO has a strong emphasis on quality, with a state-of-the-art facility and robust quality systems. Their services encompass the entire drug development process from formulation and analytical development to clinical trials, regulatory support, and commercial manufacturing. This company is actively expanding its GMP-approved manufacturing facilities and strives to provide a full range of services to support partners in overcoming the unique challenges of developing high-potency oral liquid formulations.

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Nintedanib is a medication used to treat idiopathic pulmonary fibrosis as well as in combination therapies for certain types of non-small-cell lung cancer. The nintedanib suppliers and distributors market it as 100mg and 150mg capsules. The developer and the sole nintedanib manufacturer is Boehringer Ingelheim, who acquired approval to market drug in 2014, under the trade name Ofev (in some countries – Vergatef). Ofev is currently approved in over 70 countries, and due to the ongoing validity of the supplier’s patent, other nintedanib manufacturers have yet to join the market with their formulations. Costs of nintedanib are relatively high and depend on the concentration of the active ingredient. The retail prices per 60 (100mg) capsules fall into an approximate range of 1,000 EUR to 1,200 EUR, whereas the same amount of 150mg capsules cost around 2,000 EUR to 2,250 EUR. Pharmaceutical specialists are welcome to browse through offers of nintedanib capsules for sale from nintedanib suppliers and distributors on our pharmaceutical marketplace, or else seek out further useful medical information about the medication online at the official Ofev website.