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01 1Wavelength Pharmaceuticals

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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

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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, 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.

Clascoterone Manufacturers

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

Clascoterone Suppliers

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

click here to find a list of Clascoterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

Clascoterone USDMF

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

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

click here to find a list of Clascoterone suppliers with USDMF on PharmaCompass.

Clascoterone Manufacturers | Traders | Suppliers

Clascoterone Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Clascoterone

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.