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