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USDMF
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DOSAGE - INJECTABLE;INJECTION - 20MG/ML
USFDA APPLICATION NUMBER - 11757
DOSAGE - INJECTABLE;INJECTION - 40MG/ML
USFDA APPLICATION NUMBER - 11757
DOSAGE - INJECTABLE;INJECTION - 80MG/ML
USFDA APPLICATION NUMBER - 11757
Related Excipient Companies
Nanjing Well Pharmaceutical
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PharmaCompass offers a list of Methylprednisolone Acetate 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 Acetate manufacturer or Methylprednisolone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylprednisolone Acetate manufacturer or Methylprednisolone Acetate supplier.
PharmaCompass also assists you with knowing the Methylprednisolone Acetate API Price utilized in the formulation of products. Methylprednisolone Acetate API Price is not always fixed or binding as the Methylprednisolone Acetate Price is obtained through a variety of data sources. The Methylprednisolone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Medrol Enpak manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medrol Enpak, including repackagers and relabelers. The FDA regulates Medrol Enpak manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medrol Enpak 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 Medrol Enpak manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Medrol Enpak supplier is an individual or a company that provides Medrol Enpak active pharmaceutical ingredient (API) or Medrol Enpak finished formulations upon request. The Medrol Enpak suppliers may include Medrol Enpak API manufacturers, exporters, distributors and traders.
click here to find a list of Medrol Enpak suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medrol Enpak DMF (Drug Master File) is a document detailing the whole manufacturing process of Medrol Enpak active pharmaceutical ingredient (API) in detail. Different forms of Medrol Enpak DMFs exist exist since differing nations have different regulations, such as Medrol Enpak USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medrol Enpak DMF submitted to regulatory agencies in the US is known as a USDMF. Medrol Enpak USDMF includes data on Medrol Enpak's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medrol Enpak USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medrol Enpak suppliers with USDMF on PharmaCompass.
A Medrol Enpak CEP of the European Pharmacopoeia monograph is often referred to as a Medrol Enpak Certificate of Suitability (COS). The purpose of a Medrol Enpak CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Medrol Enpak EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Medrol Enpak to their clients by showing that a Medrol Enpak CEP has been issued for it. The manufacturer submits a Medrol Enpak CEP (COS) as part of the market authorization procedure, and it takes on the role of a Medrol Enpak CEP holder for the record. Additionally, the data presented in the Medrol Enpak CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Medrol Enpak DMF.
A Medrol Enpak CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Medrol Enpak 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 Medrol Enpak suppliers with CEP (COS) on PharmaCompass.
A Medrol Enpak written confirmation (Medrol Enpak WC) is an official document issued by a regulatory agency to a Medrol Enpak manufacturer, verifying that the manufacturing facility of a Medrol Enpak active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Medrol Enpak APIs or Medrol Enpak finished pharmaceutical products to another nation, regulatory agencies frequently require a Medrol Enpak WC (written confirmation) as part of the regulatory process.
click here to find a list of Medrol Enpak 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 Medrol Enpak as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Medrol Enpak 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 Medrol Enpak 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 Medrol Enpak and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medrol Enpak NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Medrol Enpak suppliers with NDC on PharmaCompass.
Medrol Enpak 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 Medrol Enpak 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 Medrol Enpak GMP manufacturer or Medrol Enpak GMP API supplier for your needs.
A Medrol Enpak CoA (Certificate of Analysis) is a formal document that attests to Medrol Enpak's compliance with Medrol Enpak specifications and serves as a tool for batch-level quality control.
Medrol Enpak CoA mostly includes findings from lab analyses of a specific batch. For each Medrol Enpak 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.
Medrol Enpak may be tested according to a variety of international standards, such as European Pharmacopoeia (Medrol Enpak EP), Medrol Enpak JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medrol Enpak USP).
