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