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- 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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