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