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