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