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