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API SUPPLIERS
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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Drugs in Development
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DOSAGE - TABLET;ORAL - 3MG
USFDA APPLICATION NUMBER - 212018
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 212018
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 212018
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ABOUT THIS PAGE
A Erdafitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erdafitinib, including repackagers and relabelers. The FDA regulates Erdafitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erdafitinib 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 Erdafitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Erdafitinib supplier is an individual or a company that provides Erdafitinib active pharmaceutical ingredient (API) or Erdafitinib finished formulations upon request. The Erdafitinib suppliers may include Erdafitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Erdafitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Erdafitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Erdafitinib 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 Erdafitinib 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 Erdafitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Erdafitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Erdafitinib suppliers with NDC on PharmaCompass.
Erdafitinib 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 Erdafitinib 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 Erdafitinib GMP manufacturer or Erdafitinib GMP API supplier for your needs.
A Erdafitinib CoA (Certificate of Analysis) is a formal document that attests to Erdafitinib's compliance with Erdafitinib specifications and serves as a tool for batch-level quality control.
Erdafitinib CoA mostly includes findings from lab analyses of a specific batch. For each Erdafitinib 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.
Erdafitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Erdafitinib EP), Erdafitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Erdafitinib USP).
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