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