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