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