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Looking for 2392-39-4 / Dexamethasone Sodium Phosphate API manufacturers, exporters & distributors?

Dexamethasone Sodium Phosphate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Dexamethasone Sodium Phosphate

Synonyms

2392-39-4, Dexamethasone 21-phosphate disodium salt, Dalalone, Dexadreson, Dexamethasone disodium phosphate, Megacort

Cas Number

2392-39-4

Unique Ingredient Identifier (UNII)

AI9376Y64P

About Dexamethasone Sodium Phosphate

Dexamethasone Sodium Phosphate is a sodium phosphate salt form of Dexamethasone, a synthetic adrenal corticosteroid with potent anti-inflammatory properties. In addition to binding to specific nuclear steroid receptors, dexamethasone also interferes with NF-kB activation and apoptotic pathways. This agent lacks the salt-retaining properties of other related adrenal hormones. (NCI04)

Dexamethasone Sodium Phosphate Manufacturers

A Dexamethasone Sodium Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexamethasone Sodium Phosphate, including repackagers and relabelers. The FDA regulates Dexamethasone Sodium Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dexamethasone Sodium Phosphate Suppliers

A Dexamethasone Sodium Phosphate supplier is an individual or a company that provides Dexamethasone Sodium Phosphate active pharmaceutical ingredient (API) or Dexamethasone Sodium Phosphate finished formulations upon request. The Dexamethasone Sodium Phosphate suppliers may include Dexamethasone Sodium Phosphate API manufacturers, exporters, distributors and traders.

click here to find a list of Dexamethasone Sodium Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Dexamethasone Sodium Phosphate USDMF

A Dexamethasone Sodium Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexamethasone Sodium Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Dexamethasone Sodium Phosphate DMFs exist exist since differing nations have different regulations, such as Dexamethasone Sodium Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dexamethasone Sodium Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Dexamethasone Sodium Phosphate USDMF includes data on Dexamethasone Sodium Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexamethasone Sodium Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dexamethasone Sodium Phosphate suppliers with USDMF on PharmaCompass.

Dexamethasone Sodium Phosphate JDMF

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 Dexamethasone Sodium Phosphate Drug Master File in Japan (Dexamethasone Sodium Phosphate JDMF) empowers Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate suppliers with JDMF on PharmaCompass.

Dexamethasone Sodium Phosphate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Dexamethasone Sodium Phosphate Drug Master File in Korea (Dexamethasone Sodium Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexamethasone Sodium Phosphate. The MFDS reviews the Dexamethasone Sodium Phosphate KDMF as part of the drug registration process and uses the information provided in the Dexamethasone Sodium Phosphate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Dexamethasone Sodium Phosphate suppliers with KDMF on PharmaCompass.

Dexamethasone Sodium Phosphate CEP

A Dexamethasone Sodium Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Dexamethasone Sodium Phosphate Certificate of Suitability (COS). The purpose of a Dexamethasone Sodium Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexamethasone Sodium Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexamethasone Sodium Phosphate to their clients by showing that a Dexamethasone Sodium Phosphate CEP has been issued for it. The manufacturer submits a Dexamethasone Sodium Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexamethasone Sodium Phosphate CEP holder for the record. Additionally, the data presented in the Dexamethasone Sodium Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexamethasone Sodium Phosphate DMF.

A Dexamethasone Sodium Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate suppliers with CEP (COS) on PharmaCompass.

Dexamethasone Sodium Phosphate WC

A Dexamethasone Sodium Phosphate written confirmation (Dexamethasone Sodium Phosphate WC) is an official document issued by a regulatory agency to a Dexamethasone Sodium Phosphate manufacturer, verifying that the manufacturing facility of a Dexamethasone Sodium Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexamethasone Sodium Phosphate APIs or Dexamethasone Sodium Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexamethasone Sodium Phosphate WC (written confirmation) as part of the regulatory process.

click here to find a list of Dexamethasone Sodium Phosphate suppliers with Written Confirmation (WC) on PharmaCompass.

Dexamethasone Sodium Phosphate NDC

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 Dexamethasone Sodium Phosphate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dexamethasone Sodium Phosphate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Dexamethasone Sodium Phosphate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Dexamethasone Sodium Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexamethasone Sodium Phosphate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Dexamethasone Sodium Phosphate suppliers with NDC on PharmaCompass.

Dexamethasone Sodium Phosphate GMP

Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate GMP manufacturer or Dexamethasone Sodium Phosphate GMP API supplier for your needs.

Dexamethasone Sodium Phosphate CoA

A Dexamethasone Sodium Phosphate CoA (Certificate of Analysis) is a formal document that attests to Dexamethasone Sodium Phosphate's compliance with Dexamethasone Sodium Phosphate specifications and serves as a tool for batch-level quality control.

Dexamethasone Sodium Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Dexamethasone Sodium Phosphate 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.

Dexamethasone Sodium Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexamethasone Sodium Phosphate EP), Dexamethasone Sodium Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexamethasone Sodium Phosphate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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