X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
23
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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Abiraterone Acetate manufacturer or Abiraterone Acetate supplier.
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 Abiraterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abiraterone Acetate, including repackagers and relabelers. The FDA regulates Abiraterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abiraterone Acetate 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 Abiraterone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abiraterone Acetate supplier is an individual or a company that provides Abiraterone Acetate active pharmaceutical ingredient (API) or Abiraterone Acetate finished formulations upon request. The Abiraterone Acetate suppliers may include Abiraterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Abiraterone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abiraterone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Abiraterone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Abiraterone Acetate DMFs exist exist since differing nations have different regulations, such as Abiraterone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abiraterone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Abiraterone Acetate USDMF includes data on Abiraterone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abiraterone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abiraterone Acetate 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 Abiraterone Acetate Drug Master File in Japan (Abiraterone Acetate JDMF) empowers Abiraterone Acetate 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 Abiraterone Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Abiraterone Acetate 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 Abiraterone Acetate 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 Abiraterone Acetate Drug Master File in Korea (Abiraterone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Abiraterone Acetate. The MFDS reviews the Abiraterone Acetate KDMF as part of the drug registration process and uses the information provided in the Abiraterone Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Abiraterone Acetate 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 Abiraterone Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Abiraterone Acetate suppliers with KDMF on PharmaCompass.
A Abiraterone Acetate written confirmation (Abiraterone Acetate WC) is an official document issued by a regulatory agency to a Abiraterone Acetate manufacturer, verifying that the manufacturing facility of a Abiraterone Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Abiraterone Acetate APIs or Abiraterone Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Abiraterone Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Abiraterone Acetate 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 Abiraterone Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Abiraterone Acetate 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 Abiraterone Acetate 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 Abiraterone Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Abiraterone Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Abiraterone Acetate suppliers with NDC on PharmaCompass.
Abiraterone Acetate 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 Abiraterone Acetate 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 Abiraterone Acetate GMP manufacturer or Abiraterone Acetate GMP API supplier for your needs.
A Abiraterone Acetate CoA (Certificate of Analysis) is a formal document that attests to Abiraterone Acetate's compliance with Abiraterone Acetate specifications and serves as a tool for batch-level quality control.
Abiraterone Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Abiraterone Acetate 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.
Abiraterone Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Abiraterone Acetate EP), Abiraterone Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Abiraterone Acetate USP).
Market Place
