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API SUPPLIERS
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USDMF
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DOSAGE - AEROSOL, METERED;RECTAL - 10%
USFDA APPLICATION NUMBER - 17351
DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50218
DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
USFDA APPLICATION NUMBER - 50356
DOSAGE - AEROSOL, METERED;TOPICAL - 1%;1%
USFDA APPLICATION NUMBER - 86195
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ABOUT THIS PAGE
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PharmaCompass offers a list of Hydrocortisone Acetate 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 Acetate manufacturer or Hydrocortisone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Acetate manufacturer or Hydrocortisone Acetate supplier.
PharmaCompass also assists you with knowing the Hydrocortisone Acetate API Price utilized in the formulation of products. Hydrocortisone Acetate API Price is not always fixed or binding as the Hydrocortisone Acetate Price is obtained through a variety of data sources. The Hydrocortisone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A U-CORT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of U-CORT, including repackagers and relabelers. The FDA regulates U-CORT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. U-CORT 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 U-CORT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A U-CORT supplier is an individual or a company that provides U-CORT active pharmaceutical ingredient (API) or U-CORT finished formulations upon request. The U-CORT suppliers may include U-CORT API manufacturers, exporters, distributors and traders.
click here to find a list of U-CORT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A U-CORT DMF (Drug Master File) is a document detailing the whole manufacturing process of U-CORT active pharmaceutical ingredient (API) in detail. Different forms of U-CORT DMFs exist exist since differing nations have different regulations, such as U-CORT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A U-CORT DMF submitted to regulatory agencies in the US is known as a USDMF. U-CORT USDMF includes data on U-CORT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The U-CORT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of U-CORT 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 U-CORT Drug Master File in Japan (U-CORT JDMF) empowers U-CORT 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 U-CORT JDMF during the approval evaluation for pharmaceutical products. At the time of U-CORT 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 U-CORT 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 U-CORT Drug Master File in Korea (U-CORT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of U-CORT. The MFDS reviews the U-CORT KDMF as part of the drug registration process and uses the information provided in the U-CORT KDMF to evaluate the safety and efficacy of the drug.
After submitting a U-CORT 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 U-CORT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of U-CORT suppliers with KDMF on PharmaCompass.
A U-CORT CEP of the European Pharmacopoeia monograph is often referred to as a U-CORT Certificate of Suitability (COS). The purpose of a U-CORT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of U-CORT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of U-CORT to their clients by showing that a U-CORT CEP has been issued for it. The manufacturer submits a U-CORT CEP (COS) as part of the market authorization procedure, and it takes on the role of a U-CORT CEP holder for the record. Additionally, the data presented in the U-CORT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the U-CORT DMF.
A U-CORT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. U-CORT 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 U-CORT suppliers with CEP (COS) on PharmaCompass.
A U-CORT written confirmation (U-CORT WC) is an official document issued by a regulatory agency to a U-CORT manufacturer, verifying that the manufacturing facility of a U-CORT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting U-CORT APIs or U-CORT finished pharmaceutical products to another nation, regulatory agencies frequently require a U-CORT WC (written confirmation) as part of the regulatory process.
click here to find a list of U-CORT 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 U-CORT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for U-CORT 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 U-CORT 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 U-CORT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a U-CORT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of U-CORT suppliers with NDC on PharmaCompass.
U-CORT 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 U-CORT 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 U-CORT GMP manufacturer or U-CORT GMP API supplier for your needs.
A U-CORT CoA (Certificate of Analysis) is a formal document that attests to U-CORT's compliance with U-CORT specifications and serves as a tool for batch-level quality control.
U-CORT CoA mostly includes findings from lab analyses of a specific batch. For each U-CORT 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.
U-CORT may be tested according to a variety of international standards, such as European Pharmacopoeia (U-CORT EP), U-CORT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (U-CORT USP).
