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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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
38
PharmaCompass offers a list of Hydrocortisone Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A PRAMOSONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PRAMOSONE, including repackagers and relabelers. The FDA regulates PRAMOSONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PRAMOSONE 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 PRAMOSONE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A PRAMOSONE supplier is an individual or a company that provides PRAMOSONE active pharmaceutical ingredient (API) or PRAMOSONE finished formulations upon request. The PRAMOSONE suppliers may include PRAMOSONE API manufacturers, exporters, distributors and traders.
click here to find a list of PRAMOSONE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A PRAMOSONE DMF (Drug Master File) is a document detailing the whole manufacturing process of PRAMOSONE active pharmaceutical ingredient (API) in detail. Different forms of PRAMOSONE DMFs exist exist since differing nations have different regulations, such as PRAMOSONE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PRAMOSONE DMF submitted to regulatory agencies in the US is known as a USDMF. PRAMOSONE USDMF includes data on PRAMOSONE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PRAMOSONE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PRAMOSONE 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 PRAMOSONE Drug Master File in Japan (PRAMOSONE JDMF) empowers PRAMOSONE 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 PRAMOSONE JDMF during the approval evaluation for pharmaceutical products. At the time of PRAMOSONE 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 PRAMOSONE 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 PRAMOSONE Drug Master File in Korea (PRAMOSONE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PRAMOSONE. The MFDS reviews the PRAMOSONE KDMF as part of the drug registration process and uses the information provided in the PRAMOSONE KDMF to evaluate the safety and efficacy of the drug.
After submitting a PRAMOSONE 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 PRAMOSONE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PRAMOSONE suppliers with KDMF on PharmaCompass.
A PRAMOSONE CEP of the European Pharmacopoeia monograph is often referred to as a PRAMOSONE Certificate of Suitability (COS). The purpose of a PRAMOSONE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PRAMOSONE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PRAMOSONE to their clients by showing that a PRAMOSONE CEP has been issued for it. The manufacturer submits a PRAMOSONE CEP (COS) as part of the market authorization procedure, and it takes on the role of a PRAMOSONE CEP holder for the record. Additionally, the data presented in the PRAMOSONE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PRAMOSONE DMF.
A PRAMOSONE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PRAMOSONE 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 PRAMOSONE suppliers with CEP (COS) on PharmaCompass.
A PRAMOSONE written confirmation (PRAMOSONE WC) is an official document issued by a regulatory agency to a PRAMOSONE manufacturer, verifying that the manufacturing facility of a PRAMOSONE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting PRAMOSONE APIs or PRAMOSONE finished pharmaceutical products to another nation, regulatory agencies frequently require a PRAMOSONE WC (written confirmation) as part of the regulatory process.
click here to find a list of PRAMOSONE 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 PRAMOSONE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PRAMOSONE 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 PRAMOSONE 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 PRAMOSONE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PRAMOSONE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PRAMOSONE suppliers with NDC on PharmaCompass.
PRAMOSONE 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 PRAMOSONE GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right PRAMOSONE GMP manufacturer or PRAMOSONE GMP API supplier for your needs.
A PRAMOSONE CoA (Certificate of Analysis) is a formal document that attests to PRAMOSONE's compliance with PRAMOSONE specifications and serves as a tool for batch-level quality control.
PRAMOSONE CoA mostly includes findings from lab analyses of a specific batch. For each PRAMOSONE 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.
PRAMOSONE may be tested according to a variety of international standards, such as European Pharmacopoeia (PRAMOSONE EP), PRAMOSONE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PRAMOSONE USP).
