Synopsis
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JDMF
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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
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USDMF
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41559
Submission : 2025-06-17
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-26
Pay. Date : 2018-12-20
DMF Number : 33361
Submission : 2019-01-02
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-27
Pay. Date : 2018-03-30
DMF Number : 32511
Submission : 2018-03-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
With Fermion, start the journey of your innovative API.
Nintedanib esylate hemihydrate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2024-11-01
Registration Number : Su163-37-ND
Manufacturer Name : Fermion Oy, Hanko plant
Manufacturer Address : Orioninkatu 2, Hanko Pohjoinen, 10960, Finland
With Fermion, start the journey of your innovative API.
Nintedanib esylate hemihydrate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-01-12
Registration Number : Su163-23-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Lääketehtaantie 2, Oulu, FI-90660, Finland
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Nintedanib
Dosage Form : Oral
Dosage Strength : 100 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Nintedanib
Dosage Form : Oral
Dosage Strength : 150 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Nintedanib Esylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nintedanib Esylate manufacturer or Nintedanib Esylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nintedanib Esylate manufacturer or Nintedanib Esylate supplier.
A Nintedanib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nintedanib, including repackagers and relabelers. The FDA regulates Nintedanib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nintedanib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Nintedanib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nintedanib supplier is an individual or a company that provides Nintedanib active pharmaceutical ingredient (API) or Nintedanib finished formulations upon request. The Nintedanib suppliers may include Nintedanib API manufacturers, exporters, distributors and traders.
click here to find a list of Nintedanib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nintedanib DMF (Drug Master File) is a document detailing the whole manufacturing process of Nintedanib active pharmaceutical ingredient (API) in detail. Different forms of Nintedanib DMFs exist exist since differing nations have different regulations, such as Nintedanib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nintedanib DMF submitted to regulatory agencies in the US is known as a USDMF. Nintedanib USDMF includes data on Nintedanib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nintedanib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nintedanib suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nintedanib Drug Master File in Korea (Nintedanib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nintedanib. The MFDS reviews the Nintedanib KDMF as part of the drug registration process and uses the information provided in the Nintedanib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nintedanib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Nintedanib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nintedanib suppliers with KDMF on PharmaCompass.
A Nintedanib written confirmation (Nintedanib WC) is an official document issued by a regulatory agency to a Nintedanib manufacturer, verifying that the manufacturing facility of a Nintedanib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nintedanib APIs or Nintedanib finished pharmaceutical products to another nation, regulatory agencies frequently require a Nintedanib WC (written confirmation) as part of the regulatory process.
click here to find a list of Nintedanib suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nintedanib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nintedanib API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Nintedanib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Nintedanib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nintedanib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nintedanib suppliers with NDC on PharmaCompass.
Nintedanib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Nintedanib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nintedanib GMP manufacturer or Nintedanib GMP API supplier for your needs.
A Nintedanib CoA (Certificate of Analysis) is a formal document that attests to Nintedanib's compliance with Nintedanib specifications and serves as a tool for batch-level quality control.
Nintedanib CoA mostly includes findings from lab analyses of a specific batch. For each Nintedanib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Nintedanib may be tested according to a variety of international standards, such as European Pharmacopoeia (Nintedanib EP), Nintedanib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nintedanib USP).
