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GDUFA

DMF Review : Complete

Rev. Date : 2026-03-23

Pay. Date : 2026-01-26

DMF Number : 43512

Submission : 2026-01-19

Status : Active

Type : II

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

Clascoterone manufacturers, exporters & distributors 1

100

PharmaCompass offers a list of Clascoterone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.

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, and COA 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, and COA 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 Manufacturers | Traders | Suppliers

Cortexolone 17alpha-propionate Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Cortexolone 17alpha-propionate

Get in contact with the supplier of your choice:

  1. Wavelength Pharmaceuticals
  2. Aurisco Pharmaceutical
  3. Steroid SpA
  4. Teva Pharmaceutical Industries
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.