API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
78
PharmaCompass offers a list of Isoproterenol 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 Isoproterenol manufacturer or Isoproterenol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isoproterenol manufacturer or Isoproterenol supplier.
PharmaCompass also assists you with knowing the Isoproterenol API Price utilized in the formulation of products. Isoproterenol API Price is not always fixed or binding as the Isoproterenol Price is obtained through a variety of data sources. The Isoproterenol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aludrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aludrine, including repackagers and relabelers. The FDA regulates Aludrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aludrine 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 Aludrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aludrine supplier is an individual or a company that provides Aludrine active pharmaceutical ingredient (API) or Aludrine finished formulations upon request. The Aludrine suppliers may include Aludrine API manufacturers, exporters, distributors and traders.
click here to find a list of Aludrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aludrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Aludrine active pharmaceutical ingredient (API) in detail. Different forms of Aludrine DMFs exist exist since differing nations have different regulations, such as Aludrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aludrine DMF submitted to regulatory agencies in the US is known as a USDMF. Aludrine USDMF includes data on Aludrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aludrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aludrine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Aludrine Drug Master File in Japan (Aludrine JDMF) empowers Aludrine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Aludrine JDMF during the approval evaluation for pharmaceutical products. At the time of Aludrine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Aludrine suppliers with JDMF on PharmaCompass.
A Aludrine CEP of the European Pharmacopoeia monograph is often referred to as a Aludrine Certificate of Suitability (COS). The purpose of a Aludrine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aludrine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aludrine to their clients by showing that a Aludrine CEP has been issued for it. The manufacturer submits a Aludrine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aludrine CEP holder for the record. Additionally, the data presented in the Aludrine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aludrine DMF.
A Aludrine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aludrine 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 Aludrine suppliers with CEP (COS) on PharmaCompass.
A Aludrine written confirmation (Aludrine WC) is an official document issued by a regulatory agency to a Aludrine manufacturer, verifying that the manufacturing facility of a Aludrine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aludrine APIs or Aludrine finished pharmaceutical products to another nation, regulatory agencies frequently require a Aludrine WC (written confirmation) as part of the regulatory process.
click here to find a list of Aludrine 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 Aludrine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aludrine 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 Aludrine 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 Aludrine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aludrine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aludrine suppliers with NDC on PharmaCompass.
Aludrine 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 Aludrine 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 Aludrine GMP manufacturer or Aludrine GMP API supplier for your needs.
A Aludrine CoA (Certificate of Analysis) is a formal document that attests to Aludrine's compliance with Aludrine specifications and serves as a tool for batch-level quality control.
Aludrine CoA mostly includes findings from lab analyses of a specific batch. For each Aludrine 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.
Aludrine may be tested according to a variety of international standards, such as European Pharmacopoeia (Aludrine EP), Aludrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aludrine USP).