Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Regulatory Info : Deregistered
Registration Country : Sweden
Dexamethasone Sodium Metasulfobenzoate; Framycetin Sulfate; Gramicidin
Brand Name : Sofradex
Dosage Form : Eye/Ear Drops
Dosage Strength :
Packaging :
Approval Date : 09-12-1963
Application Number : 1.96E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Prescription
Registration Country : Denmark
Dexamethasone Sodium Phosphate
Brand Name : Oratories
Dosage Form : Eye Drops
Dosage Strength : 1mg/ml
Packaging :
Approval Date : 01-02-2018
Application Number : 28105891316
Regulatory Info : Prescription
Registration Country : Denmark
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oratoria
Dosage Form : Eye Drop
Dosage Strength : 1mg/ml
Packaging :
Approval Date : 09-02-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPH...DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML
USFDA APPLICATION NUMBER - 84916
DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPH...DOSAGE - INJECTABLE;INJECTION - EQ 4MG PHOSPHATE/ML
USFDA APPLICATION NUMBER - 87440
Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Solubilizers
Topical
API Stability Enhancers
Thickeners and Stabilizers
Controlled & Modified Release
Surfactant & Foaming Agents
Emulsifying Agents
Film Formers & Plasticizers
Fillers, Diluents & Binders
Rheology Modifiers
Taste Masking
Co-Processed Excipients
Direct Compression
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
25
PharmaCompass offers a list of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate manufacturer or Dexamethasone Sodium Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexamethasone Sodium Phosphate manufacturer or Dexamethasone Sodium Phosphate supplier.
A Decdan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Decdan, including repackagers and relabelers. The FDA regulates Decdan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Decdan 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 Decdan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Decdan supplier is an individual or a company that provides Decdan active pharmaceutical ingredient (API) or Decdan finished formulations upon request. The Decdan suppliers may include Decdan API manufacturers, exporters, distributors and traders.
click here to find a list of Decdan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Decdan DMF (Drug Master File) is a document detailing the whole manufacturing process of Decdan active pharmaceutical ingredient (API) in detail. Different forms of Decdan DMFs exist exist since differing nations have different regulations, such as Decdan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Decdan DMF submitted to regulatory agencies in the US is known as a USDMF. Decdan USDMF includes data on Decdan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Decdan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Decdan 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 Decdan Drug Master File in Japan (Decdan JDMF) empowers Decdan 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 Decdan JDMF during the approval evaluation for pharmaceutical products. At the time of Decdan 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 Decdan suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Decdan Drug Master File in Korea (Decdan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Decdan. The MFDS reviews the Decdan KDMF as part of the drug registration process and uses the information provided in the Decdan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Decdan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Decdan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Decdan suppliers with KDMF on PharmaCompass.
A Decdan CEP of the European Pharmacopoeia monograph is often referred to as a Decdan Certificate of Suitability (COS). The purpose of a Decdan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Decdan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Decdan to their clients by showing that a Decdan CEP has been issued for it. The manufacturer submits a Decdan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Decdan CEP holder for the record. Additionally, the data presented in the Decdan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Decdan DMF.
A Decdan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Decdan 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 Decdan suppliers with CEP (COS) on PharmaCompass.
A Decdan written confirmation (Decdan WC) is an official document issued by a regulatory agency to a Decdan manufacturer, verifying that the manufacturing facility of a Decdan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Decdan APIs or Decdan finished pharmaceutical products to another nation, regulatory agencies frequently require a Decdan WC (written confirmation) as part of the regulatory process.
click here to find a list of Decdan 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 Decdan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Decdan 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 Decdan 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 Decdan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Decdan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Decdan suppliers with NDC on PharmaCompass.
Decdan 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 Decdan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Decdan GMP manufacturer or Decdan GMP API supplier for your needs.
A Decdan CoA (Certificate of Analysis) is a formal document that attests to Decdan's compliance with Decdan specifications and serves as a tool for batch-level quality control.
Decdan CoA mostly includes findings from lab analyses of a specific batch. For each Decdan 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.
Decdan may be tested according to a variety of international standards, such as European Pharmacopoeia (Decdan EP), Decdan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Decdan USP).
