Synopsis
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JDMF
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EU WC
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KDMF
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
API SUPPLIERS
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USDMF
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5319
Submission : 1984-04-06
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R0-CEP 2021-310 - Rev 00
Status : Valid
Issue Date : 2023-02-06
Type : Chemical
Substance Number : 1312
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Certificate Number : CEP 2016-337 - Rev 01
Status : Valid
Issue Date : 2024-01-09
Type : Chemical
Substance Number : 1312
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]VMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
VMF Number : 5602
Submission : 1997-09-05
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
VMF Number : 6493
Submission : 2022-12-01
Status :
Type : II
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Listed Suppliers
Chirogate is a professional Prostaglandin manufacturer.
About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. Focused on quality and compliance, it offers competitively priced p...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ilomedin
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 20mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ilomedin
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 20mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Not Marketed
Registration Country : Norway
Brand Name : Ventavis
Dosage Form : Solution For Inhalation
Dosage Strength : 10mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Not Marketed
Registration Country : Norway
Regulatory Info : Not Marketed
Registration Country : Norway
Brand Name : Ventavis
Dosage Form : Solution For Inhalation
Dosage Strength : 10mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Not Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ventavis
Dosage Form : Solution For Inhalation
Dosage Strength : 10mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Ventavis
Dosage Form : Solution For Inhalation
Dosage Strength : 20mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Ventavis
Dosage Form : Solution For Inhalation By Nebulizer
Dosage Strength : 10MCG
Packaging :
Approval Date : 18-09-2007
Application Number : 3255004
Regulatory Info : Authorized
Registration Country : Spain
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Topical
Solubilizers
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Dinoprost Tromethamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dinoprost Tromethamine manufacturer or Dinoprost Tromethamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dinoprost Tromethamine manufacturer or Dinoprost Tromethamine supplier.
A Dinoprost Tromethamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dinoprost Tromethamine, including repackagers and relabelers. The FDA regulates Dinoprost Tromethamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dinoprost Tromethamine 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 Dinoprost Tromethamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dinoprost Tromethamine supplier is an individual or a company that provides Dinoprost Tromethamine active pharmaceutical ingredient (API) or Dinoprost Tromethamine finished formulations upon request. The Dinoprost Tromethamine suppliers may include Dinoprost Tromethamine API manufacturers, exporters, distributors and traders.
click here to find a list of Dinoprost Tromethamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dinoprost Tromethamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dinoprost Tromethamine active pharmaceutical ingredient (API) in detail. Different forms of Dinoprost Tromethamine DMFs exist exist since differing nations have different regulations, such as Dinoprost Tromethamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dinoprost Tromethamine DMF submitted to regulatory agencies in the US is known as a USDMF. Dinoprost Tromethamine USDMF includes data on Dinoprost Tromethamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dinoprost Tromethamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dinoprost Tromethamine suppliers with USDMF on PharmaCompass.
A Dinoprost Tromethamine CEP of the European Pharmacopoeia monograph is often referred to as a Dinoprost Tromethamine Certificate of Suitability (COS). The purpose of a Dinoprost Tromethamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dinoprost Tromethamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dinoprost Tromethamine to their clients by showing that a Dinoprost Tromethamine CEP has been issued for it. The manufacturer submits a Dinoprost Tromethamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dinoprost Tromethamine CEP holder for the record. Additionally, the data presented in the Dinoprost Tromethamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dinoprost Tromethamine DMF.
A Dinoprost Tromethamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dinoprost Tromethamine 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 Dinoprost Tromethamine suppliers with CEP (COS) 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 Dinoprost Tromethamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dinoprost Tromethamine 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 Dinoprost Tromethamine 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 Dinoprost Tromethamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dinoprost Tromethamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dinoprost Tromethamine suppliers with NDC on PharmaCompass.
Dinoprost Tromethamine 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 Dinoprost Tromethamine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dinoprost Tromethamine GMP manufacturer or Dinoprost Tromethamine GMP API supplier for your needs.
A Dinoprost Tromethamine CoA (Certificate of Analysis) is a formal document that attests to Dinoprost Tromethamine's compliance with Dinoprost Tromethamine specifications and serves as a tool for batch-level quality control.
Dinoprost Tromethamine CoA mostly includes findings from lab analyses of a specific batch. For each Dinoprost Tromethamine 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.
Dinoprost Tromethamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Dinoprost Tromethamine EP), Dinoprost Tromethamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dinoprost Tromethamine USP).
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