Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Click Us!
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Human Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.
Axplora is your partner of choice for complex APIs.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CEP/COS
JDMF
NDC
KDMF
ASMF
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-04
Pay. Date : 2022-02-28
DMF Number : 6525
Submission : 1986-08-11
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-28
Pay. Date : 2013-01-16
DMF Number : 3963
Submission : 1980-10-10
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Dexamethasone Sodium Phosphate
Certificate Number : R1-CEP 1998-154 - Rev 06
Status : Valid
Issue Date : 2021-07-07
Type : Chemical
Substance Number : 549
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dexamethasone Sodium Phosphate
Certificate Number : R2-CEP 1992-014 - Rev 07
Status : Valid
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 549
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]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
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
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]Actylis
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]Solubilizers
Parenteral
Topical
Controlled & Modified Release
Emulsifying Agents
Surfactant & Foaming Agents
Thickeners and Stabilizers
Film Formers & Plasticizers
Co-Processed Excipients
Direct Compression
Rheology Modifiers
API Stability Enhancers
Digital Content
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
86
PharmaCompass offers a list of Dexamethasone Sodium Phosphate 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 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.
PharmaCompass also assists you with knowing the Dexamethasone Sodium Phosphate API Price utilized in the formulation of products. Dexamethasone Sodium Phosphate API Price is not always fixed or binding as the Dexamethasone Sodium Phosphate Price is obtained through a variety of data sources. The Dexamethasone Sodium Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexagel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexagel, including repackagers and relabelers. The FDA regulates Dexagel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexagel 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 Dexagel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexagel supplier is an individual or a company that provides Dexagel active pharmaceutical ingredient (API) or Dexagel finished formulations upon request. The Dexagel suppliers may include Dexagel API manufacturers, exporters, distributors and traders.
click here to find a list of Dexagel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexagel DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexagel active pharmaceutical ingredient (API) in detail. Different forms of Dexagel DMFs exist exist since differing nations have different regulations, such as Dexagel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexagel DMF submitted to regulatory agencies in the US is known as a USDMF. Dexagel USDMF includes data on Dexagel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexagel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexagel 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 Dexagel Drug Master File in Japan (Dexagel JDMF) empowers Dexagel 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 Dexagel JDMF during the approval evaluation for pharmaceutical products. At the time of Dexagel 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 Dexagel 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 Dexagel Drug Master File in Korea (Dexagel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexagel. The MFDS reviews the Dexagel KDMF as part of the drug registration process and uses the information provided in the Dexagel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexagel 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 Dexagel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexagel suppliers with KDMF on PharmaCompass.
A Dexagel CEP of the European Pharmacopoeia monograph is often referred to as a Dexagel Certificate of Suitability (COS). The purpose of a Dexagel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexagel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexagel to their clients by showing that a Dexagel CEP has been issued for it. The manufacturer submits a Dexagel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexagel CEP holder for the record. Additionally, the data presented in the Dexagel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexagel DMF.
A Dexagel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexagel 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 Dexagel suppliers with CEP (COS) on PharmaCompass.
A Dexagel written confirmation (Dexagel WC) is an official document issued by a regulatory agency to a Dexagel manufacturer, verifying that the manufacturing facility of a Dexagel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexagel APIs or Dexagel finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexagel WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexagel 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 Dexagel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexagel 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 Dexagel 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 Dexagel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexagel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexagel suppliers with NDC on PharmaCompass.
Dexagel 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 Dexagel 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 Dexagel GMP manufacturer or Dexagel GMP API supplier for your needs.
A Dexagel CoA (Certificate of Analysis) is a formal document that attests to Dexagel's compliance with Dexagel specifications and serves as a tool for batch-level quality control.
Dexagel CoA mostly includes findings from lab analyses of a specific batch. For each Dexagel 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.
Dexagel may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexagel EP), Dexagel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexagel USP).
