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List of Drug Master Files (DMF) of Difamilast Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Otsuka Holdings (1)

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01 OPA-15406 DRUG SUBSTANCE (1)

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2016-05-23
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Looking for 937782-05-3 / Difamilast API manufacturers, exporters & distributors?

Difamilast manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Difamilast

Synonyms

Opa-15406, 937782-05-3, Difamilast [usan], T3u32glj0f, N-[[2-[4-(difluoromethoxy)-3-propan-2-yloxyphenyl]-1,3-oxazol-4-yl]methyl]-2-ethoxybenzamide, Benzamide, n-((2-(4-(difluoromethoxy)-3-(1-methylethoxy)phenyl)-4-oxazolyl)methyl)-2-ethoxy-

Cas Number

937782-05-3

Unique Ingredient Identifier (UNII)

T3U32GLJ0F

About Difamilast

Difamilast is under investigation in clinical trial NCT01702181 (A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis).

Difamilast Manufacturers

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

Difamilast Suppliers

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

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

Difamilast USDMF

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

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

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

Difamilast Manufacturers | Traders | Suppliers

Difamilast Manufacturers, Traders, Suppliers 1
87

We have 1 companies offering Difamilast

Get in contact with the supplier of your choice:

  1. Otsuka Holdings
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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