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Find Hydrocortisone manufacturers, exporters & distributors on PharmaCompass

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  • SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%
  • OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
  • CREAM;TOPICAL - 1%
  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 20MG
  • TABLET;ORAL - 5MG

Looking for 50-23-7 / Hydrocortisone API manufacturers, exporters & distributors?

Hydrocortisone manufacturers, exporters & distributors 1

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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.

API | Excipient name

Hydrocortisone

Synonyms

Cortisol, 50-23-7, Acticort, Cetacort, Cortef, Hydrasson

Cas Number

50-23-7

Unique Ingredient Identifier (UNII)

WI4X0X7BPJ

About Hydrocortisone

The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

11beta-Hydroxycortisone Manufacturers

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

11beta-Hydroxycortisone Suppliers

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

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

11beta-Hydroxycortisone USDMF

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

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

click here to find a list of 11beta-Hydroxycortisone suppliers with USDMF on PharmaCompass.

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

11beta-Hydroxycortisone KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 11beta-Hydroxycortisone Drug Master File in Korea (11beta-Hydroxycortisone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 11beta-Hydroxycortisone. The MFDS reviews the 11beta-Hydroxycortisone KDMF as part of the drug registration process and uses the information provided in the 11beta-Hydroxycortisone KDMF to evaluate the safety and efficacy of the drug.

After submitting a 11beta-Hydroxycortisone 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 11beta-Hydroxycortisone API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 11beta-Hydroxycortisone suppliers with KDMF on PharmaCompass.

11beta-Hydroxycortisone CEP

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

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

11beta-Hydroxycortisone WC

A 11beta-Hydroxycortisone written confirmation (11beta-Hydroxycortisone WC) is an official document issued by a regulatory agency to a 11beta-Hydroxycortisone manufacturer, verifying that the manufacturing facility of a 11beta-Hydroxycortisone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 11beta-Hydroxycortisone APIs or 11beta-Hydroxycortisone finished pharmaceutical products to another nation, regulatory agencies frequently require a 11beta-Hydroxycortisone WC (written confirmation) as part of the regulatory process.

click here to find a list of 11beta-Hydroxycortisone suppliers with Written Confirmation (WC) on PharmaCompass.

11beta-Hydroxycortisone 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 11beta-Hydroxycortisone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 11beta-Hydroxycortisone 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 11beta-Hydroxycortisone 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 11beta-Hydroxycortisone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 11beta-Hydroxycortisone NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 11beta-Hydroxycortisone suppliers with NDC on PharmaCompass.

11beta-Hydroxycortisone GMP

11beta-Hydroxycortisone 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 11beta-Hydroxycortisone 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 11beta-Hydroxycortisone GMP manufacturer or 11beta-Hydroxycortisone GMP API supplier for your needs.

11beta-Hydroxycortisone CoA

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

11beta-Hydroxycortisone CoA mostly includes findings from lab analyses of a specific batch. For each 11beta-Hydroxycortisone 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.

11beta-Hydroxycortisone may be tested according to a variety of international standards, such as European Pharmacopoeia (11beta-Hydroxycortisone EP), 11beta-Hydroxycortisone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (11beta-Hydroxycortisone 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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