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