X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
63
PharmaCompass offers a list of Alvimopan 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 Alvimopan manufacturer or Alvimopan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alvimopan manufacturer or Alvimopan supplier.
PharmaCompass also assists you with knowing the Alvimopan API Price utilized in the formulation of products. Alvimopan API Price is not always fixed or binding as the Alvimopan Price is obtained through a variety of data sources. The Alvimopan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alvimopan Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alvimopan Dihydrate, including repackagers and relabelers. The FDA regulates Alvimopan Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alvimopan Dihydrate 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 Alvimopan Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alvimopan Dihydrate supplier is an individual or a company that provides Alvimopan Dihydrate active pharmaceutical ingredient (API) or Alvimopan Dihydrate finished formulations upon request. The Alvimopan Dihydrate suppliers may include Alvimopan Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Alvimopan Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alvimopan Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Alvimopan Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Alvimopan Dihydrate DMFs exist exist since differing nations have different regulations, such as Alvimopan Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alvimopan Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Alvimopan Dihydrate USDMF includes data on Alvimopan Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alvimopan Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alvimopan Dihydrate suppliers with USDMF on PharmaCompass.
A Alvimopan Dihydrate written confirmation (Alvimopan Dihydrate WC) is an official document issued by a regulatory agency to a Alvimopan Dihydrate manufacturer, verifying that the manufacturing facility of a Alvimopan Dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alvimopan Dihydrate APIs or Alvimopan Dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Alvimopan Dihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Alvimopan Dihydrate 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 Alvimopan Dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alvimopan Dihydrate 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 Alvimopan Dihydrate 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 Alvimopan Dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alvimopan Dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alvimopan Dihydrate suppliers with NDC on PharmaCompass.
Alvimopan Dihydrate 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 Alvimopan Dihydrate 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 Alvimopan Dihydrate GMP manufacturer or Alvimopan Dihydrate GMP API supplier for your needs.
A Alvimopan Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Alvimopan Dihydrate's compliance with Alvimopan Dihydrate specifications and serves as a tool for batch-level quality control.
Alvimopan Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Alvimopan Dihydrate 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.
Alvimopan Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Alvimopan Dihydrate EP), Alvimopan Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alvimopan Dihydrate USP).
Market Place
