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Looking for 50-04-4 / Cortisone API manufacturers, exporters & distributors?

Cortisone manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cortisone 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 Cortisone manufacturer or Cortisone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cortisone manufacturer or Cortisone supplier.

PharmaCompass also assists you with knowing the Cortisone API Price utilized in the formulation of products. Cortisone API Price is not always fixed or binding as the Cortisone Price is obtained through a variety of data sources. The Cortisone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cortisone

Synonyms

Cortisone 21-acetate, 50-04-4, Cortone acetate, Incortin, Biocort acetate, Artriona

Cas Number

50-04-4

Unique Ingredient Identifier (UNII)

883WKN7W8X

About Cortisone

A naturally occurring glucocorticoid that has been used in replacement therapy for ADRENAL INSUFFICIENCY and as an anti-inflammatory agent. Cortisone itself is inactive; it is converted in the liver to the active metabolite HYDROCORTISONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p726)

11-Dehydro-17-hydroxycorticosterone acetate Manufacturers

A 11-Dehydro-17-hydroxycorticosterone acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 11-Dehydro-17-hydroxycorticosterone acetate, including repackagers and relabelers. The FDA regulates 11-Dehydro-17-hydroxycorticosterone acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 11-Dehydro-17-hydroxycorticosterone acetate 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 11-Dehydro-17-hydroxycorticosterone acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

11-Dehydro-17-hydroxycorticosterone acetate Suppliers

A 11-Dehydro-17-hydroxycorticosterone acetate supplier is an individual or a company that provides 11-Dehydro-17-hydroxycorticosterone acetate active pharmaceutical ingredient (API) or 11-Dehydro-17-hydroxycorticosterone acetate finished formulations upon request. The 11-Dehydro-17-hydroxycorticosterone acetate suppliers may include 11-Dehydro-17-hydroxycorticosterone acetate API manufacturers, exporters, distributors and traders.

click here to find a list of 11-Dehydro-17-hydroxycorticosterone acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

11-Dehydro-17-hydroxycorticosterone acetate USDMF

A 11-Dehydro-17-hydroxycorticosterone acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of 11-Dehydro-17-hydroxycorticosterone acetate active pharmaceutical ingredient (API) in detail. Different forms of 11-Dehydro-17-hydroxycorticosterone acetate DMFs exist exist since differing nations have different regulations, such as 11-Dehydro-17-hydroxycorticosterone acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 11-Dehydro-17-hydroxycorticosterone acetate DMF submitted to regulatory agencies in the US is known as a USDMF. 11-Dehydro-17-hydroxycorticosterone acetate USDMF includes data on 11-Dehydro-17-hydroxycorticosterone acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 11-Dehydro-17-hydroxycorticosterone acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 11-Dehydro-17-hydroxycorticosterone acetate suppliers with USDMF on PharmaCompass.

11-Dehydro-17-hydroxycorticosterone acetate JDMF

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 11-Dehydro-17-hydroxycorticosterone acetate Drug Master File in Japan (11-Dehydro-17-hydroxycorticosterone acetate JDMF) empowers 11-Dehydro-17-hydroxycorticosterone acetate 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 11-Dehydro-17-hydroxycorticosterone acetate JDMF during the approval evaluation for pharmaceutical products. At the time of 11-Dehydro-17-hydroxycorticosterone acetate 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 11-Dehydro-17-hydroxycorticosterone acetate suppliers with JDMF on PharmaCompass.

11-Dehydro-17-hydroxycorticosterone acetate CEP

A 11-Dehydro-17-hydroxycorticosterone acetate CEP of the European Pharmacopoeia monograph is often referred to as a 11-Dehydro-17-hydroxycorticosterone acetate Certificate of Suitability (COS). The purpose of a 11-Dehydro-17-hydroxycorticosterone acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 11-Dehydro-17-hydroxycorticosterone acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 11-Dehydro-17-hydroxycorticosterone acetate to their clients by showing that a 11-Dehydro-17-hydroxycorticosterone acetate CEP has been issued for it. The manufacturer submits a 11-Dehydro-17-hydroxycorticosterone acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 11-Dehydro-17-hydroxycorticosterone acetate CEP holder for the record. Additionally, the data presented in the 11-Dehydro-17-hydroxycorticosterone acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 11-Dehydro-17-hydroxycorticosterone acetate DMF.

A 11-Dehydro-17-hydroxycorticosterone acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 11-Dehydro-17-hydroxycorticosterone acetate 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 11-Dehydro-17-hydroxycorticosterone acetate suppliers with CEP (COS) on PharmaCompass.

11-Dehydro-17-hydroxycorticosterone acetate NDC

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 11-Dehydro-17-hydroxycorticosterone acetate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 11-Dehydro-17-hydroxycorticosterone acetate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 11-Dehydro-17-hydroxycorticosterone acetate 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 11-Dehydro-17-hydroxycorticosterone acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 11-Dehydro-17-hydroxycorticosterone acetate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 11-Dehydro-17-hydroxycorticosterone acetate suppliers with NDC on PharmaCompass.

11-Dehydro-17-hydroxycorticosterone acetate GMP

11-Dehydro-17-hydroxycorticosterone acetate 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 11-Dehydro-17-hydroxycorticosterone acetate 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 11-Dehydro-17-hydroxycorticosterone acetate GMP manufacturer or 11-Dehydro-17-hydroxycorticosterone acetate GMP API supplier for your needs.

11-Dehydro-17-hydroxycorticosterone acetate CoA

A 11-Dehydro-17-hydroxycorticosterone acetate CoA (Certificate of Analysis) is a formal document that attests to 11-Dehydro-17-hydroxycorticosterone acetate's compliance with 11-Dehydro-17-hydroxycorticosterone acetate specifications and serves as a tool for batch-level quality control.

11-Dehydro-17-hydroxycorticosterone acetate CoA mostly includes findings from lab analyses of a specific batch. For each 11-Dehydro-17-hydroxycorticosterone acetate 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.

11-Dehydro-17-hydroxycorticosterone acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (11-Dehydro-17-hydroxycorticosterone acetate EP), 11-Dehydro-17-hydroxycorticosterone acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (11-Dehydro-17-hydroxycorticosterone acetate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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