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