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PharmaCompass offers a list of Abiraterone Acetate 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 Abiraterone Acetate manufacturer or Abiraterone Acetate supplier for your needs.
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PharmaCompass also assists you with knowing the Abiraterone Acetate API Price utilized in the formulation of products. Abiraterone Acetate API Price is not always fixed or binding as the Abiraterone Acetate Price is obtained through a variety of data sources. The Abiraterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DSSTox_CID_28969 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_28969, including repackagers and relabelers. The FDA regulates DSSTox_CID_28969 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_28969 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 DSSTox_CID_28969 supplier is an individual or a company that provides DSSTox_CID_28969 active pharmaceutical ingredient (API) or DSSTox_CID_28969 finished formulations upon request. The DSSTox_CID_28969 suppliers may include DSSTox_CID_28969 API manufacturers, exporters, distributors and traders.
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A DSSTox_CID_28969 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_28969 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_28969 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_28969 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSSTox_CID_28969 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_28969 USDMF includes data on DSSTox_CID_28969's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_28969 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 DSSTox_CID_28969 Drug Master File in Japan (DSSTox_CID_28969 JDMF) empowers DSSTox_CID_28969 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 DSSTox_CID_28969 JDMF during the approval evaluation for pharmaceutical products. At the time of DSSTox_CID_28969 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 DSSTox_CID_28969 Drug Master File in Korea (DSSTox_CID_28969 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DSSTox_CID_28969. The MFDS reviews the DSSTox_CID_28969 KDMF as part of the drug registration process and uses the information provided in the DSSTox_CID_28969 KDMF to evaluate the safety and efficacy of the drug.
After submitting a DSSTox_CID_28969 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 DSSTox_CID_28969 API can apply through the Korea Drug Master File (KDMF).
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A DSSTox_CID_28969 written confirmation (DSSTox_CID_28969 WC) is an official document issued by a regulatory agency to a DSSTox_CID_28969 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_28969 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_28969 APIs or DSSTox_CID_28969 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_28969 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 DSSTox_CID_28969 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_28969 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 DSSTox_CID_28969 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 DSSTox_CID_28969 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_28969 NDC to their finished compounded human drug products, they may choose to do so.
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DSSTox_CID_28969 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 DSSTox_CID_28969 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 DSSTox_CID_28969 GMP manufacturer or DSSTox_CID_28969 GMP API supplier for your needs.
A DSSTox_CID_28969 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_28969's compliance with DSSTox_CID_28969 specifications and serves as a tool for batch-level quality control.
DSSTox_CID_28969 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_28969 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.
DSSTox_CID_28969 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_28969 EP), DSSTox_CID_28969 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_28969 USP).
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