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Drugs in Development
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methyl 1-acetyl-3-(methoxy(phenyl)methylene)-2-oxo...
CAS Number : 1168152-07-5
End Use API : Nintedanib Esylate
About The Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services co...
With Fermion, start the journey of your innovative API.
N-(4-aminophenyl)-N-methyl-2-(4-methylpiperazin-1-...
CAS Number : 262368-30-9
End Use API : Nintedanib Esylate
About The Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services co...
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A Nintedanib Esylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nintedanib Esylate, including repackagers and relabelers. The FDA regulates Nintedanib Esylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nintedanib Esylate 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 Esylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nintedanib Esylate supplier is an individual or a company that provides Nintedanib Esylate active pharmaceutical ingredient (API) or Nintedanib Esylate finished formulations upon request. The Nintedanib Esylate suppliers may include Nintedanib Esylate API manufacturers, exporters, distributors and traders.
click here to find a list of Nintedanib Esylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nintedanib Esylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nintedanib Esylate active pharmaceutical ingredient (API) in detail. Different forms of Nintedanib Esylate DMFs exist exist since differing nations have different regulations, such as Nintedanib Esylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nintedanib Esylate DMF submitted to regulatory agencies in the US is known as a USDMF. Nintedanib Esylate USDMF includes data on Nintedanib Esylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nintedanib Esylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nintedanib Esylate 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 Esylate Drug Master File in Korea (Nintedanib Esylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nintedanib Esylate. The MFDS reviews the Nintedanib Esylate KDMF as part of the drug registration process and uses the information provided in the Nintedanib Esylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nintedanib Esylate 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 Esylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nintedanib Esylate suppliers with KDMF on PharmaCompass.
A Nintedanib Esylate written confirmation (Nintedanib Esylate WC) is an official document issued by a regulatory agency to a Nintedanib Esylate manufacturer, verifying that the manufacturing facility of a Nintedanib Esylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nintedanib Esylate APIs or Nintedanib Esylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Nintedanib Esylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Nintedanib Esylate 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 Esylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nintedanib Esylate 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 Esylate 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 Esylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nintedanib Esylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nintedanib Esylate suppliers with NDC on PharmaCompass.
Nintedanib Esylate 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 Esylate 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 Nintedanib Esylate GMP manufacturer or Nintedanib Esylate GMP API supplier for your needs.
A Nintedanib Esylate CoA (Certificate of Analysis) is a formal document that attests to Nintedanib Esylate's compliance with Nintedanib Esylate specifications and serves as a tool for batch-level quality control.
Nintedanib Esylate CoA mostly includes findings from lab analyses of a specific batch. For each Nintedanib Esylate 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 Esylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Nintedanib Esylate EP), Nintedanib Esylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nintedanib Esylate USP).
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