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KDMF
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API SUPPLIERS
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USDMF
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EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Minakem
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
46
PharmaCompass offers a list of Prednisolone 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 Prednisolone Sodium Phosphate manufacturer or Prednisolone Sodium Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisolone Sodium Phosphate manufacturer or Prednisolone Sodium Phosphate supplier.
A Solucort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solucort, including repackagers and relabelers. The FDA regulates Solucort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solucort 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 Solucort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Solucort supplier is an individual or a company that provides Solucort active pharmaceutical ingredient (API) or Solucort finished formulations upon request. The Solucort suppliers may include Solucort API manufacturers, exporters, distributors and traders.
click here to find a list of Solucort suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Solucort DMF (Drug Master File) is a document detailing the whole manufacturing process of Solucort active pharmaceutical ingredient (API) in detail. Different forms of Solucort DMFs exist exist since differing nations have different regulations, such as Solucort USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solucort DMF submitted to regulatory agencies in the US is known as a USDMF. Solucort USDMF includes data on Solucort's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solucort USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Solucort 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 Solucort Drug Master File in Japan (Solucort JDMF) empowers Solucort 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 Solucort JDMF during the approval evaluation for pharmaceutical products. At the time of Solucort 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 Solucort suppliers with JDMF on PharmaCompass.
A Solucort CEP of the European Pharmacopoeia monograph is often referred to as a Solucort Certificate of Suitability (COS). The purpose of a Solucort CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Solucort EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Solucort to their clients by showing that a Solucort CEP has been issued for it. The manufacturer submits a Solucort CEP (COS) as part of the market authorization procedure, and it takes on the role of a Solucort CEP holder for the record. Additionally, the data presented in the Solucort CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Solucort DMF.
A Solucort CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Solucort 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 Solucort suppliers with CEP (COS) on PharmaCompass.
A Solucort written confirmation (Solucort WC) is an official document issued by a regulatory agency to a Solucort manufacturer, verifying that the manufacturing facility of a Solucort active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Solucort APIs or Solucort finished pharmaceutical products to another nation, regulatory agencies frequently require a Solucort WC (written confirmation) as part of the regulatory process.
click here to find a list of Solucort 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 Solucort as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Solucort 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 Solucort 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 Solucort and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Solucort NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Solucort suppliers with NDC on PharmaCompass.
Solucort 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 Solucort GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Solucort GMP manufacturer or Solucort GMP API supplier for your needs.
A Solucort CoA (Certificate of Analysis) is a formal document that attests to Solucort's compliance with Solucort specifications and serves as a tool for batch-level quality control.
Solucort CoA mostly includes findings from lab analyses of a specific batch. For each Solucort 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.
Solucort may be tested according to a variety of international standards, such as European Pharmacopoeia (Solucort EP), Solucort JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Solucort USP).
