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DOSAGE - CAPSULE;ORAL - EQ 2.3MG BASE
USFDA APPLICATION NUMBER - 208462
DOSAGE - CAPSULE;ORAL - EQ 3MG BASE
USFDA APPLICATION NUMBER - 208462
DOSAGE - CAPSULE;ORAL - EQ 4MG BASE
USFDA APPLICATION NUMBER - 208462
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ABOUT THIS PAGE
A Ixazomib Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ixazomib Citrate, including repackagers and relabelers. The FDA regulates Ixazomib Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ixazomib Citrate 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 Ixazomib Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ixazomib Citrate supplier is an individual or a company that provides Ixazomib Citrate active pharmaceutical ingredient (API) or Ixazomib Citrate finished formulations upon request. The Ixazomib Citrate suppliers may include Ixazomib Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Ixazomib Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ixazomib Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ixazomib Citrate active pharmaceutical ingredient (API) in detail. Different forms of Ixazomib Citrate DMFs exist exist since differing nations have different regulations, such as Ixazomib Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ixazomib Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Ixazomib Citrate USDMF includes data on Ixazomib Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ixazomib Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ixazomib Citrate 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 Ixazomib Citrate Drug Master File in Korea (Ixazomib Citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ixazomib Citrate. The MFDS reviews the Ixazomib Citrate KDMF as part of the drug registration process and uses the information provided in the Ixazomib Citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ixazomib Citrate 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 Ixazomib Citrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ixazomib Citrate suppliers with KDMF on PharmaCompass.
A Ixazomib Citrate written confirmation (Ixazomib Citrate WC) is an official document issued by a regulatory agency to a Ixazomib Citrate manufacturer, verifying that the manufacturing facility of a Ixazomib Citrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ixazomib Citrate APIs or Ixazomib Citrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ixazomib Citrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Ixazomib Citrate 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 Ixazomib Citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ixazomib Citrate 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 Ixazomib Citrate 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 Ixazomib Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ixazomib Citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ixazomib Citrate suppliers with NDC on PharmaCompass.
Ixazomib Citrate 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 Ixazomib Citrate 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 Ixazomib Citrate GMP manufacturer or Ixazomib Citrate GMP API supplier for your needs.
A Ixazomib Citrate CoA (Certificate of Analysis) is a formal document that attests to Ixazomib Citrate's compliance with Ixazomib Citrate specifications and serves as a tool for batch-level quality control.
Ixazomib Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Ixazomib Citrate 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.
Ixazomib Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ixazomib Citrate EP), Ixazomib Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ixazomib Citrate USP).
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