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USDMF
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DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
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ABOUT THIS PAGE
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PharmaCompass offers a list of Hydrocortisone Sodium Succinate 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 Hydrocortisone Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier.
PharmaCompass also assists you with knowing the Hydrocortisone Sodium Succinate API Price utilized in the formulation of products. Hydrocortisone Sodium Succinate API Price is not always fixed or binding as the Hydrocortisone Sodium Succinate Price is obtained through a variety of data sources. The Hydrocortisone Sodium Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)-, including repackagers and relabelers. The FDA regulates Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- supplier is an individual or a company that provides Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- active pharmaceutical ingredient (API) or Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- finished formulations upon request. The Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- suppliers may include Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- API manufacturers, exporters, distributors and traders.
click here to find a list of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- DMF (Drug Master File) is a document detailing the whole manufacturing process of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- active pharmaceutical ingredient (API) in detail. Different forms of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- DMFs exist exist since differing nations have different regulations, such as Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- DMF submitted to regulatory agencies in the US is known as a USDMF. Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- USDMF includes data on Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)-'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- Drug Master File in Japan (Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- JDMF) empowers Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- JDMF during the approval evaluation for pharmaceutical products. At the time of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- suppliers with JDMF on PharmaCompass.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP of the European Pharmacopoeia monograph is often referred to as a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- Certificate of Suitability (COS). The purpose of a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- to their clients by showing that a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP has been issued for it. The manufacturer submits a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP holder for the record. Additionally, the data presented in the Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- DMF.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- suppliers with CEP (COS) on PharmaCompass.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- written confirmation (Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- WC) is an official document issued by a regulatory agency to a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- manufacturer, verifying that the manufacturing facility of a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- APIs or Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- finished pharmaceutical products to another nation, regulatory agencies frequently require a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- WC (written confirmation) as part of the regulatory process.
click here to find a list of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- suppliers with NDC on PharmaCompass.
Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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 Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- GMP manufacturer or Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- GMP API supplier for your needs.
A Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CoA (Certificate of Analysis) is a formal document that attests to Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)-'s compliance with Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- specifications and serves as a tool for batch-level quality control.
Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- CoA mostly includes findings from lab analyses of a specific batch. For each Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- 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.
Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- may be tested according to a variety of international standards, such as European Pharmacopoeia (Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- EP), Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pregn-4-ene-3,20-dione, 21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11beta)- USP).
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