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DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0.125MG BASE
USFDA APPLICATION NUMBER - 203496
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0.25MG BASE
USFDA APPLICATION NUMBER - 203496
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1MG BASE
USFDA APPLICATION NUMBER - 203496
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2.5MG BASE
USFDA APPLICATION NUMBER - 203496
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 203496
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ABOUT THIS PAGE
A Treprostinil Diolamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Treprostinil Diolamine, including repackagers and relabelers. The FDA regulates Treprostinil Diolamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Treprostinil Diolamine 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 Treprostinil Diolamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Treprostinil Diolamine supplier is an individual or a company that provides Treprostinil Diolamine active pharmaceutical ingredient (API) or Treprostinil Diolamine finished formulations upon request. The Treprostinil Diolamine suppliers may include Treprostinil Diolamine API manufacturers, exporters, distributors and traders.
click here to find a list of Treprostinil Diolamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Treprostinil Diolamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Treprostinil Diolamine active pharmaceutical ingredient (API) in detail. Different forms of Treprostinil Diolamine DMFs exist exist since differing nations have different regulations, such as Treprostinil Diolamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Treprostinil Diolamine DMF submitted to regulatory agencies in the US is known as a USDMF. Treprostinil Diolamine USDMF includes data on Treprostinil Diolamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Treprostinil Diolamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Treprostinil Diolamine suppliers with USDMF on PharmaCompass.
A Treprostinil Diolamine written confirmation (Treprostinil Diolamine WC) is an official document issued by a regulatory agency to a Treprostinil Diolamine manufacturer, verifying that the manufacturing facility of a Treprostinil Diolamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Treprostinil Diolamine APIs or Treprostinil Diolamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Treprostinil Diolamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Treprostinil Diolamine 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 Treprostinil Diolamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Treprostinil Diolamine 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 Treprostinil Diolamine 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 Treprostinil Diolamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Treprostinil Diolamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Treprostinil Diolamine suppliers with NDC on PharmaCompass.
Treprostinil Diolamine 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 Treprostinil Diolamine 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 Treprostinil Diolamine GMP manufacturer or Treprostinil Diolamine GMP API supplier for your needs.
A Treprostinil Diolamine CoA (Certificate of Analysis) is a formal document that attests to Treprostinil Diolamine's compliance with Treprostinil Diolamine specifications and serves as a tool for batch-level quality control.
Treprostinil Diolamine CoA mostly includes findings from lab analyses of a specific batch. For each Treprostinil Diolamine 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.
Treprostinil Diolamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Treprostinil Diolamine EP), Treprostinil Diolamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Treprostinil Diolamine USP).
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