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USDMF
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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
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Nanjing Well Pharmaceutical
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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, 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 Soldesam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Soldesam, including repackagers and relabelers. The FDA regulates Soldesam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Soldesam 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 Soldesam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Soldesam supplier is an individual or a company that provides Soldesam active pharmaceutical ingredient (API) or Soldesam finished formulations upon request. The Soldesam suppliers may include Soldesam API manufacturers, exporters, distributors and traders.
click here to find a list of Soldesam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Soldesam DMF (Drug Master File) is a document detailing the whole manufacturing process of Soldesam active pharmaceutical ingredient (API) in detail. Different forms of Soldesam DMFs exist exist since differing nations have different regulations, such as Soldesam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Soldesam DMF submitted to regulatory agencies in the US is known as a USDMF. Soldesam USDMF includes data on Soldesam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Soldesam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Soldesam 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 Soldesam Drug Master File in Japan (Soldesam JDMF) empowers Soldesam 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 Soldesam JDMF during the approval evaluation for pharmaceutical products. At the time of Soldesam 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 Soldesam 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 Soldesam Drug Master File in Korea (Soldesam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Soldesam. The MFDS reviews the Soldesam KDMF as part of the drug registration process and uses the information provided in the Soldesam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Soldesam 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 Soldesam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Soldesam suppliers with KDMF on PharmaCompass.
A Soldesam CEP of the European Pharmacopoeia monograph is often referred to as a Soldesam Certificate of Suitability (COS). The purpose of a Soldesam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Soldesam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Soldesam to their clients by showing that a Soldesam CEP has been issued for it. The manufacturer submits a Soldesam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Soldesam CEP holder for the record. Additionally, the data presented in the Soldesam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Soldesam DMF.
A Soldesam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Soldesam 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 Soldesam suppliers with CEP (COS) on PharmaCompass.
A Soldesam written confirmation (Soldesam WC) is an official document issued by a regulatory agency to a Soldesam manufacturer, verifying that the manufacturing facility of a Soldesam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Soldesam APIs or Soldesam finished pharmaceutical products to another nation, regulatory agencies frequently require a Soldesam WC (written confirmation) as part of the regulatory process.
click here to find a list of Soldesam 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 Soldesam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Soldesam 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 Soldesam 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 Soldesam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Soldesam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Soldesam suppliers with NDC on PharmaCompass.
Soldesam 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 Soldesam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Soldesam GMP manufacturer or Soldesam GMP API supplier for your needs.
A Soldesam CoA (Certificate of Analysis) is a formal document that attests to Soldesam's compliance with Soldesam specifications and serves as a tool for batch-level quality control.
Soldesam CoA mostly includes findings from lab analyses of a specific batch. For each Soldesam 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.
Soldesam may be tested according to a variety of international standards, such as European Pharmacopoeia (Soldesam EP), Soldesam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Soldesam USP).
