API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
19
PharmaCompass offers a list of Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate manufacturer or Prednisolone Hemisuccinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisolone Hemisuccinate manufacturer or Prednisolone Hemisuccinate supplier.
PharmaCompass also assists you with knowing the Prednisolone Hemisuccinate API Price utilized in the formulation of products. Prednisolone Hemisuccinate API Price is not always fixed or binding as the Prednisolone Hemisuccinate Price is obtained through a variety of data sources. The Prednisolone Hemisuccinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prednisolone Hemisuccinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prednisolone Hemisuccinate, including repackagers and relabelers. The FDA regulates Prednisolone Hemisuccinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prednisolone Hemisuccinate supplier is an individual or a company that provides Prednisolone Hemisuccinate active pharmaceutical ingredient (API) or Prednisolone Hemisuccinate finished formulations upon request. The Prednisolone Hemisuccinate suppliers may include Prednisolone Hemisuccinate API manufacturers, exporters, distributors and traders.
click here to find a list of Prednisolone Hemisuccinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prednisolone Hemisuccinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prednisolone Hemisuccinate active pharmaceutical ingredient (API) in detail. Different forms of Prednisolone Hemisuccinate DMFs exist exist since differing nations have different regulations, such as Prednisolone Hemisuccinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prednisolone Hemisuccinate DMF submitted to regulatory agencies in the US is known as a USDMF. Prednisolone Hemisuccinate USDMF includes data on Prednisolone Hemisuccinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prednisolone Hemisuccinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prednisolone Hemisuccinate suppliers with USDMF on PharmaCompass.
A Prednisolone Hemisuccinate CEP of the European Pharmacopoeia monograph is often referred to as a Prednisolone Hemisuccinate Certificate of Suitability (COS). The purpose of a Prednisolone Hemisuccinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prednisolone Hemisuccinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prednisolone Hemisuccinate to their clients by showing that a Prednisolone Hemisuccinate CEP has been issued for it. The manufacturer submits a Prednisolone Hemisuccinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prednisolone Hemisuccinate CEP holder for the record. Additionally, the data presented in the Prednisolone Hemisuccinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prednisolone Hemisuccinate DMF.
A Prednisolone Hemisuccinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate suppliers with CEP (COS) on PharmaCompass.
A Prednisolone Hemisuccinate written confirmation (Prednisolone Hemisuccinate WC) is an official document issued by a regulatory agency to a Prednisolone Hemisuccinate manufacturer, verifying that the manufacturing facility of a Prednisolone Hemisuccinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prednisolone Hemisuccinate APIs or Prednisolone Hemisuccinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Prednisolone Hemisuccinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prednisolone Hemisuccinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prednisolone Hemisuccinate suppliers with NDC on PharmaCompass.
Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate 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 Prednisolone Hemisuccinate GMP manufacturer or Prednisolone Hemisuccinate GMP API supplier for your needs.
A Prednisolone Hemisuccinate CoA (Certificate of Analysis) is a formal document that attests to Prednisolone Hemisuccinate's compliance with Prednisolone Hemisuccinate specifications and serves as a tool for batch-level quality control.
Prednisolone Hemisuccinate CoA mostly includes findings from lab analyses of a specific batch. For each Prednisolone Hemisuccinate 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.
Prednisolone Hemisuccinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prednisolone Hemisuccinate EP), Prednisolone Hemisuccinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prednisolone Hemisuccinate USP).