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