US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Adapalene 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 Adapalene manufacturer or Adapalene supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Adapalene manufacturer or Adapalene supplier.
PharmaCompass also assists you with knowing the Adapalene API Price utilized in the formulation of products. Adapalene API Price is not always fixed or binding as the Adapalene Price is obtained through a variety of data sources. The Adapalene Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Adapalene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adapalene, including repackagers and relabelers. The FDA regulates Adapalene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adapalene 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 Adapalene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Adapalene supplier is an individual or a company that provides Adapalene active pharmaceutical ingredient (API) or Adapalene finished formulations upon request. The Adapalene suppliers may include Adapalene API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Adapalene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Adapalene DMF (Drug Master File) is a document detailing the whole manufacturing process of Adapalene active pharmaceutical ingredient (API) in detail. Different forms of Adapalene DMFs exist exist since differing nations have different regulations, such as Adapalene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adapalene DMF submitted to regulatory agencies in the US is known as a USDMF. Adapalene USDMF includes data on Adapalene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adapalene USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Adapalene Drug Master File in Japan (Adapalene JDMF) empowers Adapalene API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Adapalene JDMF during the approval evaluation for pharmaceutical products. At the time of Adapalene JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 Adapalene Drug Master File in Korea (Adapalene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Adapalene. The MFDS reviews the Adapalene KDMF as part of the drug registration process and uses the information provided in the Adapalene KDMF to evaluate the safety and efficacy of the drug.
After submitting a Adapalene 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 Adapalene API can apply through the Korea Drug Master File (KDMF).
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A Adapalene CEP of the European Pharmacopoeia monograph is often referred to as a Adapalene Certificate of Suitability (COS). The purpose of a Adapalene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Adapalene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Adapalene to their clients by showing that a Adapalene CEP has been issued for it. The manufacturer submits a Adapalene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Adapalene CEP holder for the record. Additionally, the data presented in the Adapalene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Adapalene DMF.
A Adapalene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Adapalene CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Adapalene written confirmation (Adapalene WC) is an official document issued by a regulatory agency to a Adapalene manufacturer, verifying that the manufacturing facility of a Adapalene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Adapalene APIs or Adapalene finished pharmaceutical products to another nation, regulatory agencies frequently require a Adapalene 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 Adapalene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Adapalene 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 Adapalene 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 Adapalene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Adapalene NDC to their finished compounded human drug products, they may choose to do so.
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Adapalene 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 Adapalene 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 Adapalene GMP manufacturer or Adapalene GMP API supplier for your needs.
A Adapalene CoA (Certificate of Analysis) is a formal document that attests to Adapalene's compliance with Adapalene specifications and serves as a tool for batch-level quality control.
Adapalene CoA mostly includes findings from lab analyses of a specific batch. For each Adapalene 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.
Adapalene may be tested according to a variety of international standards, such as European Pharmacopoeia (Adapalene EP), Adapalene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Adapalene USP).