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