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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
Related Excipient Companies
Nanjing Well Pharmaceutical
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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 Hydrocortisone Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone Succinate, including repackagers and relabelers. The FDA regulates Hydrocortisone Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone Succinate 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 Hydrocortisone Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone Succinate supplier is an individual or a company that provides Hydrocortisone Succinate active pharmaceutical ingredient (API) or Hydrocortisone Succinate finished formulations upon request. The Hydrocortisone Succinate suppliers may include Hydrocortisone Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocortisone Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocortisone Succinate active pharmaceutical ingredient (API) in detail. Different forms of Hydrocortisone Succinate DMFs exist exist since differing nations have different regulations, such as Hydrocortisone Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocortisone Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocortisone Succinate USDMF includes data on Hydrocortisone Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocortisone Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocortisone Succinate 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 Hydrocortisone Succinate Drug Master File in Japan (Hydrocortisone Succinate JDMF) empowers Hydrocortisone Succinate 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 Hydrocortisone Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydrocortisone Succinate 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 Hydrocortisone Succinate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Hydrocortisone Succinate Drug Master File in Korea (Hydrocortisone Succinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydrocortisone Succinate. The MFDS reviews the Hydrocortisone Succinate KDMF as part of the drug registration process and uses the information provided in the Hydrocortisone Succinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydrocortisone Succinate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Hydrocortisone Succinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydrocortisone Succinate suppliers with KDMF on PharmaCompass.
A Hydrocortisone Succinate CEP of the European Pharmacopoeia monograph is often referred to as a Hydrocortisone Succinate Certificate of Suitability (COS). The purpose of a Hydrocortisone Succinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydrocortisone Succinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydrocortisone Succinate to their clients by showing that a Hydrocortisone Succinate CEP has been issued for it. The manufacturer submits a Hydrocortisone Succinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydrocortisone Succinate CEP holder for the record. Additionally, the data presented in the Hydrocortisone Succinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydrocortisone Succinate DMF.
A Hydrocortisone Succinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydrocortisone Succinate 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 Hydrocortisone Succinate suppliers with CEP (COS) on PharmaCompass.
A Hydrocortisone Succinate written confirmation (Hydrocortisone Succinate WC) is an official document issued by a regulatory agency to a Hydrocortisone Succinate manufacturer, verifying that the manufacturing facility of a Hydrocortisone Succinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydrocortisone Succinate APIs or Hydrocortisone Succinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydrocortisone Succinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydrocortisone Succinate 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 Hydrocortisone Succinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydrocortisone Succinate 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 Hydrocortisone Succinate 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 Hydrocortisone Succinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydrocortisone Succinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydrocortisone Succinate suppliers with NDC on PharmaCompass.
Hydrocortisone Succinate 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 Hydrocortisone Succinate 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 Hydrocortisone Succinate GMP manufacturer or Hydrocortisone Succinate GMP API supplier for your needs.
A Hydrocortisone Succinate CoA (Certificate of Analysis) is a formal document that attests to Hydrocortisone Succinate's compliance with Hydrocortisone Succinate specifications and serves as a tool for batch-level quality control.
Hydrocortisone Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Hydrocortisone Succinate 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.
Hydrocortisone Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydrocortisone Succinate EP), Hydrocortisone Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydrocortisone Succinate USP).
