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