Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Parenteral
Solubilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
53
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 Solu-Cortef manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solu-Cortef, including repackagers and relabelers. The FDA regulates Solu-Cortef manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solu-Cortef 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 Solu-Cortef manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Solu-Cortef supplier is an individual or a company that provides Solu-Cortef active pharmaceutical ingredient (API) or Solu-Cortef finished formulations upon request. The Solu-Cortef suppliers may include Solu-Cortef API manufacturers, exporters, distributors and traders.
click here to find a list of Solu-Cortef suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Solu-Cortef DMF (Drug Master File) is a document detailing the whole manufacturing process of Solu-Cortef active pharmaceutical ingredient (API) in detail. Different forms of Solu-Cortef DMFs exist exist since differing nations have different regulations, such as Solu-Cortef USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solu-Cortef DMF submitted to regulatory agencies in the US is known as a USDMF. Solu-Cortef USDMF includes data on Solu-Cortef's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solu-Cortef USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Solu-Cortef 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 Solu-Cortef Drug Master File in Japan (Solu-Cortef JDMF) empowers Solu-Cortef 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 Solu-Cortef JDMF during the approval evaluation for pharmaceutical products. At the time of Solu-Cortef 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 Solu-Cortef 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 Solu-Cortef Drug Master File in Korea (Solu-Cortef KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Solu-Cortef. The MFDS reviews the Solu-Cortef KDMF as part of the drug registration process and uses the information provided in the Solu-Cortef KDMF to evaluate the safety and efficacy of the drug.
After submitting a Solu-Cortef 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 Solu-Cortef API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Solu-Cortef suppliers with KDMF on PharmaCompass.
A Solu-Cortef CEP of the European Pharmacopoeia monograph is often referred to as a Solu-Cortef Certificate of Suitability (COS). The purpose of a Solu-Cortef CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Solu-Cortef EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Solu-Cortef to their clients by showing that a Solu-Cortef CEP has been issued for it. The manufacturer submits a Solu-Cortef CEP (COS) as part of the market authorization procedure, and it takes on the role of a Solu-Cortef CEP holder for the record. Additionally, the data presented in the Solu-Cortef CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Solu-Cortef DMF.
A Solu-Cortef CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Solu-Cortef 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 Solu-Cortef suppliers with CEP (COS) on PharmaCompass.
A Solu-Cortef written confirmation (Solu-Cortef WC) is an official document issued by a regulatory agency to a Solu-Cortef manufacturer, verifying that the manufacturing facility of a Solu-Cortef active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Solu-Cortef APIs or Solu-Cortef finished pharmaceutical products to another nation, regulatory agencies frequently require a Solu-Cortef WC (written confirmation) as part of the regulatory process.
click here to find a list of Solu-Cortef 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 Solu-Cortef as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Solu-Cortef 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 Solu-Cortef 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 Solu-Cortef and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Solu-Cortef NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Solu-Cortef suppliers with NDC on PharmaCompass.
Solu-Cortef 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 Solu-Cortef 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 Solu-Cortef GMP manufacturer or Solu-Cortef GMP API supplier for your needs.
A Solu-Cortef CoA (Certificate of Analysis) is a formal document that attests to Solu-Cortef's compliance with Solu-Cortef specifications and serves as a tool for batch-level quality control.
Solu-Cortef CoA mostly includes findings from lab analyses of a specific batch. For each Solu-Cortef 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.
Solu-Cortef may be tested according to a variety of international standards, such as European Pharmacopoeia (Solu-Cortef EP), Solu-Cortef JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Solu-Cortef USP).
