API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
68
PharmaCompass offers a list of Albendazole 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 Albendazole manufacturer or Albendazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Albendazole manufacturer or Albendazole supplier.
PharmaCompass also assists you with knowing the Albendazole API Price utilized in the formulation of products. Albendazole API Price is not always fixed or binding as the Albendazole Price is obtained through a variety of data sources. The Albendazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Biwom manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biwom, including repackagers and relabelers. The FDA regulates Biwom manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biwom 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 Biwom manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biwom supplier is an individual or a company that provides Biwom active pharmaceutical ingredient (API) or Biwom finished formulations upon request. The Biwom suppliers may include Biwom API manufacturers, exporters, distributors and traders.
click here to find a list of Biwom suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Biwom DMF (Drug Master File) is a document detailing the whole manufacturing process of Biwom active pharmaceutical ingredient (API) in detail. Different forms of Biwom DMFs exist exist since differing nations have different regulations, such as Biwom USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Biwom DMF submitted to regulatory agencies in the US is known as a USDMF. Biwom USDMF includes data on Biwom's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Biwom USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Biwom suppliers with USDMF on PharmaCompass.
A Biwom CEP of the European Pharmacopoeia monograph is often referred to as a Biwom Certificate of Suitability (COS). The purpose of a Biwom CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Biwom EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Biwom to their clients by showing that a Biwom CEP has been issued for it. The manufacturer submits a Biwom CEP (COS) as part of the market authorization procedure, and it takes on the role of a Biwom CEP holder for the record. Additionally, the data presented in the Biwom CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Biwom DMF.
A Biwom CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Biwom 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 Biwom suppliers with CEP (COS) on PharmaCompass.
A Biwom written confirmation (Biwom WC) is an official document issued by a regulatory agency to a Biwom manufacturer, verifying that the manufacturing facility of a Biwom active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Biwom APIs or Biwom finished pharmaceutical products to another nation, regulatory agencies frequently require a Biwom WC (written confirmation) as part of the regulatory process.
click here to find a list of Biwom 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 Biwom as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Biwom 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 Biwom 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 Biwom and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Biwom NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Biwom suppliers with NDC on PharmaCompass.
Biwom 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 Biwom 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 Biwom GMP manufacturer or Biwom GMP API supplier for your needs.
A Biwom CoA (Certificate of Analysis) is a formal document that attests to Biwom's compliance with Biwom specifications and serves as a tool for batch-level quality control.
Biwom CoA mostly includes findings from lab analyses of a specific batch. For each Biwom 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.
Biwom may be tested according to a variety of international standards, such as European Pharmacopoeia (Biwom EP), Biwom JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Biwom USP).