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Looking for 19608-29-8 / Clascoterone API manufacturers, exporters & distributors?

Clascoterone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Clascoterone

Synonyms

19608-29-8, Cb-03-01, 17 alpha-propionate, 17alpha-propionate, Winlevi, Cortexolone 17 alpha-propionate

Cas Number

19608-29-8

Unique Ingredient Identifier (UNII)

XN7MM8XG2M

About Clascoterone

Clascoterone (cortexolone 17-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity. By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways. In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older. Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.

Cortexolone 17alpha-propionate Manufacturers

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

Cortexolone 17alpha-propionate Suppliers

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

click here to find a list of Cortexolone 17alpha-propionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cortexolone 17alpha-propionate USDMF

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

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

click here to find a list of Cortexolone 17alpha-propionate suppliers with USDMF on PharmaCompass.

Cortexolone 17alpha-propionate 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 Cortexolone 17alpha-propionate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cortexolone 17alpha-propionate 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 Cortexolone 17alpha-propionate 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 Cortexolone 17alpha-propionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cortexolone 17alpha-propionate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cortexolone 17alpha-propionate suppliers with NDC on PharmaCompass.

Cortexolone 17alpha-propionate GMP

Cortexolone 17alpha-propionate 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 Cortexolone 17alpha-propionate 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 Cortexolone 17alpha-propionate GMP manufacturer or Cortexolone 17alpha-propionate GMP API supplier for your needs.

Cortexolone 17alpha-propionate CoA

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

Cortexolone 17alpha-propionate CoA mostly includes findings from lab analyses of a specific batch. For each Cortexolone 17alpha-propionate 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.

Cortexolone 17alpha-propionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cortexolone 17alpha-propionate EP), Cortexolone 17alpha-propionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cortexolone 17alpha-propionate 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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