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