X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
28
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 Glycort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycort, including repackagers and relabelers. The FDA regulates Glycort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycort 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 Glycort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycort supplier is an individual or a company that provides Glycort active pharmaceutical ingredient (API) or Glycort finished formulations upon request. The Glycort suppliers may include Glycort API manufacturers, exporters, distributors and traders.
click here to find a list of Glycort suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycort DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycort active pharmaceutical ingredient (API) in detail. Different forms of Glycort DMFs exist exist since differing nations have different regulations, such as Glycort USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycort DMF submitted to regulatory agencies in the US is known as a USDMF. Glycort USDMF includes data on Glycort's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycort USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycort 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 Glycort Drug Master File in Japan (Glycort JDMF) empowers Glycort 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 Glycort JDMF during the approval evaluation for pharmaceutical products. At the time of Glycort 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 Glycort 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 Glycort Drug Master File in Korea (Glycort KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glycort. The MFDS reviews the Glycort KDMF as part of the drug registration process and uses the information provided in the Glycort KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glycort 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 Glycort API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glycort suppliers with KDMF on PharmaCompass.
A Glycort CEP of the European Pharmacopoeia monograph is often referred to as a Glycort Certificate of Suitability (COS). The purpose of a Glycort CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glycort EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glycort to their clients by showing that a Glycort CEP has been issued for it. The manufacturer submits a Glycort CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glycort CEP holder for the record. Additionally, the data presented in the Glycort CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glycort DMF.
A Glycort CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glycort 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 Glycort suppliers with CEP (COS) on PharmaCompass.
A Glycort written confirmation (Glycort WC) is an official document issued by a regulatory agency to a Glycort manufacturer, verifying that the manufacturing facility of a Glycort active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glycort APIs or Glycort finished pharmaceutical products to another nation, regulatory agencies frequently require a Glycort WC (written confirmation) as part of the regulatory process.
click here to find a list of Glycort 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 Glycort as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glycort 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 Glycort 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 Glycort and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glycort NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glycort suppliers with NDC on PharmaCompass.
Glycort 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 Glycort 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 Glycort GMP manufacturer or Glycort GMP API supplier for your needs.
A Glycort CoA (Certificate of Analysis) is a formal document that attests to Glycort's compliance with Glycort specifications and serves as a tool for batch-level quality control.
Glycort CoA mostly includes findings from lab analyses of a specific batch. For each Glycort 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.
Glycort may be tested according to a variety of international standards, such as European Pharmacopoeia (Glycort EP), Glycort JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glycort USP).
Market Place
