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