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