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PharmaCompass offers a list of Paclitaxel 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 Paclitaxel manufacturer or Paclitaxel supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Paclitaxel manufacturer or Paclitaxel supplier.
PharmaCompass also assists you with knowing the Paclitaxel API Price utilized in the formulation of products. Paclitaxel API Price is not always fixed or binding as the Paclitaxel Price is obtained through a variety of data sources. The Paclitaxel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine, including repackagers and relabelers. The FDA regulates 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine supplier is an individual or a company that provides 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine active pharmaceutical ingredient (API) or 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine finished formulations upon request. The 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine suppliers may include 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine API manufacturers, exporters, distributors and traders.
click here to find a list of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine DMF (Drug Master File) is a document detailing the whole manufacturing process of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine active pharmaceutical ingredient (API) in detail. Different forms of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine DMFs exist exist since differing nations have different regulations, such as 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine DMF submitted to regulatory agencies in the US is known as a USDMF. 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine USDMF includes data on 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine Drug Master File in Japan (12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine JDMF) empowers 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine JDMF during the approval evaluation for pharmaceutical products. At the time of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine Drug Master File in Korea (12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. The MFDS reviews the 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine KDMF as part of the drug registration process and uses the information provided in the 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine KDMF to evaluate the safety and efficacy of the drug.
After submitting a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine API can apply through the Korea Drug Master File (KDMF).
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A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP of the European Pharmacopoeia monograph is often referred to as a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine Certificate of Suitability (COS). The purpose of a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine to their clients by showing that a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP has been issued for it. The manufacturer submits a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP (COS) as part of the market authorization procedure, and it takes on the role of a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP holder for the record. Additionally, the data presented in the 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine DMF.
A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine written confirmation (12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine WC) is an official document issued by a regulatory agency to a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine manufacturer, verifying that the manufacturing facility of a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine APIs or 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine finished pharmaceutical products to another nation, regulatory agencies frequently require a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine NDC to their finished compounded human drug products, they may choose to do so.
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12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine GMP manufacturer or 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine GMP API supplier for your needs.
A 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CoA (Certificate of Analysis) is a formal document that attests to 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine's compliance with 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine specifications and serves as a tool for batch-level quality control.
12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine CoA mostly includes findings from lab analyses of a specific batch. For each 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine 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.
12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine may be tested according to a variety of international standards, such as European Pharmacopoeia (12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine EP), 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine USP).