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