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List of Drug Master Files (KDMF) for MENTAX-TC Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Kaken Pharmaceutical Co., Ltd. Shizuoka Factory (1)

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01 Samo Pharmaceutical Co., Ltd. (1)

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01 Butenafine hydrochloride (1)

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01 Japan (1)

URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2023-03-23
20230323-211-J-1455
Kaken Pharmaceutical Co.,...
Japan
301-banchi, Gensuke, Fuji...
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Looking for 101827-46-7 / Butenafine API manufacturers, exporters & distributors?

Butenafine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Butenafine

Synonyms

101827-46-7, Butenafine hcl, Mentax, Kp-363, Butenafine (hydrochloride), Volley

Cas Number

101827-46-7

Unique Ingredient Identifier (UNII)

R8XA2029ZI

About Butenafine

Butenafine Hydrochloride is the hydrochloride salt form of butenafine, a synthetic benzylamine derivative with fungicidal properties. Butenafine hydrochloride interferes with the biosynthesis of ergosterol, an important component of fungal cell membranes, by inhibiting the epoxidation of squalene. This alters fungal membrane permeability and causes growth inhibition. Butenafine hydrochloride is active against a number of dermatophytes, including Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis, Sporothrix schenckii, and yeasts, including Candida albicans and C. parapsilosis.

MENTAX-TC Manufacturers

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

MENTAX-TC Suppliers

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

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

MENTAX-TC KDMF

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

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

After submitting a MENTAX-TC 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 MENTAX-TC API can apply through the Korea Drug Master File (KDMF).

click here to find a list of MENTAX-TC suppliers with KDMF on PharmaCompass.

MENTAX-TC Manufacturers | Traders | Suppliers

MENTAX-TC Manufacturers, Traders, Suppliers 1
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We have 1 companies offering MENTAX-TC

Get in contact with the supplier of your choice:

  1. Kaken Pharmaceuticals
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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