Synopsis
0
CEP/COS
0
JDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
With Fermion, start the journey of your innovative API.
KDMF 
ASMF
Veranova: A CDMO that manages complexity with confidence.
ROW
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
With Fermion, start the journey of your innovative API.
ASMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
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]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
60
PharmaCompass offers a list of Nintedanib Esylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,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.
PharmaCompass also assists you with knowing the Nintedanib Esylate API Price utilized in the formulation of products. Nintedanib Esylate API Price is not always fixed or binding as the Nintedanib Esylate Price is obtained through a variety of data sources. The Nintedanib Esylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A OFEV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of OFEV, including repackagers and relabelers. The FDA regulates OFEV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. OFEV 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 OFEV manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A OFEV supplier is an individual or a company that provides OFEV active pharmaceutical ingredient (API) or OFEV finished formulations upon request. The OFEV suppliers may include OFEV API manufacturers, exporters, distributors and traders.
click here to find a list of OFEV suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A OFEV DMF (Drug Master File) is a document detailing the whole manufacturing process of OFEV active pharmaceutical ingredient (API) in detail. Different forms of OFEV DMFs exist exist since differing nations have different regulations, such as OFEV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A OFEV DMF submitted to regulatory agencies in the US is known as a USDMF. OFEV USDMF includes data on OFEV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The OFEV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of OFEV 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 OFEV Drug Master File in Korea (OFEV KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of OFEV. The MFDS reviews the OFEV KDMF as part of the drug registration process and uses the information provided in the OFEV KDMF to evaluate the safety and efficacy of the drug.
After submitting a OFEV 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 OFEV API can apply through the Korea Drug Master File (KDMF).
click here to find a list of OFEV suppliers with KDMF on PharmaCompass.
A OFEV written confirmation (OFEV WC) is an official document issued by a regulatory agency to a OFEV manufacturer, verifying that the manufacturing facility of a OFEV active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting OFEV APIs or OFEV finished pharmaceutical products to another nation, regulatory agencies frequently require a OFEV WC (written confirmation) as part of the regulatory process.
click here to find a list of OFEV 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 OFEV as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for OFEV 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 OFEV 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 OFEV and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a OFEV NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of OFEV suppliers with NDC on PharmaCompass.
OFEV 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 OFEV GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right OFEV GMP manufacturer or OFEV GMP API supplier for your needs.
A OFEV CoA (Certificate of Analysis) is a formal document that attests to OFEV's compliance with OFEV specifications and serves as a tool for batch-level quality control.
OFEV CoA mostly includes findings from lab analyses of a specific batch. For each OFEV 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.
OFEV may be tested according to a variety of international standards, such as European Pharmacopoeia (OFEV EP), OFEV JP (Japanese Pharmacopeia) and the US Pharmacopoeia (OFEV USP).
