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PharmaCompass offers a list of Methylprednisolone 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 Methylprednisolone manufacturer or Methylprednisolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylprednisolone manufacturer or Methylprednisolone supplier.
PharmaCompass also assists you with knowing the Methylprednisolone API Price utilized in the formulation of products. Methylprednisolone API Price is not always fixed or binding as the Methylprednisolone Price is obtained through a variety of data sources. The Methylprednisolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione, including repackagers and relabelers. The FDA regulates 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione supplier is an individual or a company that provides 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione active pharmaceutical ingredient (API) or 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione finished formulations upon request. The 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione suppliers may include 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione API manufacturers, exporters, distributors and traders.
click here to find a list of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione DMF (Drug Master File) is a document detailing the whole manufacturing process of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione active pharmaceutical ingredient (API) in detail. Different forms of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione DMFs exist exist since differing nations have different regulations, such as 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione DMF submitted to regulatory agencies in the US is known as a USDMF. 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione USDMF includes data on 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione Drug Master File in Korea (11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione. The MFDS reviews the 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione KDMF as part of the drug registration process and uses the information provided in the 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione KDMF to evaluate the safety and efficacy of the drug.
After submitting a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione API can apply through the Korea Drug Master File (KDMF).
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A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP of the European Pharmacopoeia monograph is often referred to as a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione Certificate of Suitability (COS). The purpose of a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione to their clients by showing that a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP has been issued for it. The manufacturer submits a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP (COS) as part of the market authorization procedure, and it takes on the role of a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP holder for the record. Additionally, the data presented in the 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione DMF.
A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione written confirmation (11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione WC) is an official document issued by a regulatory agency to a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione manufacturer, verifying that the manufacturing facility of a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione APIs or 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione finished pharmaceutical products to another nation, regulatory agencies frequently require a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione WC (written confirmation) as part of the regulatory process.
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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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione NDC to their finished compounded human drug products, they may choose to do so.
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11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione GMP manufacturer or 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione GMP API supplier for your needs.
A 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CoA (Certificate of Analysis) is a formal document that attests to 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione's compliance with 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione specifications and serves as a tool for batch-level quality control.
11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione CoA mostly includes findings from lab analyses of a specific batch. For each 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione 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.
11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione may be tested according to a variety of international standards, such as European Pharmacopoeia (11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione EP), 11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione JP (Japanese Pharmacopeia) and the US Pharmacopoeia (11-beta,17,21-Trihydroxy-6-alpha-methylpregna-1,4-diene-3,20-dione USP).