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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 100MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 250MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
USFDA APPLICATION NUMBER - 9866
Related Excipient Companies
Nanjing Well Pharmaceutical
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Parenteral
Solubilizers
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Hydrocortisone Sodium Succinate 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 Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocortisone Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier.
PharmaCompass also assists you with knowing the Hydrocortisone Sodium Succinate API Price utilized in the formulation of products. Hydrocortisone Sodium Succinate API Price is not always fixed or binding as the Hydrocortisone Sodium Succinate Price is obtained through a variety of data sources. The Hydrocortisone Sodium Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rapicort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rapicort, including repackagers and relabelers. The FDA regulates Rapicort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rapicort 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 Rapicort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rapicort supplier is an individual or a company that provides Rapicort active pharmaceutical ingredient (API) or Rapicort finished formulations upon request. The Rapicort suppliers may include Rapicort API manufacturers, exporters, distributors and traders.
click here to find a list of Rapicort suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rapicort DMF (Drug Master File) is a document detailing the whole manufacturing process of Rapicort active pharmaceutical ingredient (API) in detail. Different forms of Rapicort DMFs exist exist since differing nations have different regulations, such as Rapicort USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rapicort DMF submitted to regulatory agencies in the US is known as a USDMF. Rapicort USDMF includes data on Rapicort's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rapicort USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rapicort 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 Rapicort Drug Master File in Japan (Rapicort JDMF) empowers Rapicort 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 Rapicort JDMF during the approval evaluation for pharmaceutical products. At the time of Rapicort 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 Rapicort 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 Rapicort Drug Master File in Korea (Rapicort KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rapicort. The MFDS reviews the Rapicort KDMF as part of the drug registration process and uses the information provided in the Rapicort KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rapicort 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 Rapicort API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rapicort suppliers with KDMF on PharmaCompass.
A Rapicort CEP of the European Pharmacopoeia monograph is often referred to as a Rapicort Certificate of Suitability (COS). The purpose of a Rapicort CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rapicort EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rapicort to their clients by showing that a Rapicort CEP has been issued for it. The manufacturer submits a Rapicort CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rapicort CEP holder for the record. Additionally, the data presented in the Rapicort CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rapicort DMF.
A Rapicort CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rapicort 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 Rapicort suppliers with CEP (COS) on PharmaCompass.
A Rapicort written confirmation (Rapicort WC) is an official document issued by a regulatory agency to a Rapicort manufacturer, verifying that the manufacturing facility of a Rapicort active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rapicort APIs or Rapicort finished pharmaceutical products to another nation, regulatory agencies frequently require a Rapicort WC (written confirmation) as part of the regulatory process.
click here to find a list of Rapicort 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 Rapicort as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rapicort 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 Rapicort 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 Rapicort and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rapicort NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rapicort suppliers with NDC on PharmaCompass.
Rapicort 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 Rapicort 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 Rapicort GMP manufacturer or Rapicort GMP API supplier for your needs.
A Rapicort CoA (Certificate of Analysis) is a formal document that attests to Rapicort's compliance with Rapicort specifications and serves as a tool for batch-level quality control.
Rapicort CoA mostly includes findings from lab analyses of a specific batch. For each Rapicort 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.
Rapicort may be tested according to a variety of international standards, such as European Pharmacopoeia (Rapicort EP), Rapicort JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rapicort USP).
