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List of Drug Master Files (JDMF) for Difluprednate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Farmabios S. p. A. (1)

02 Sicor Societa (') Italiana Corticosteroidi S. r. l. (1)

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01 Difluprednate (1)

02 Difluprednate "Teva" (1)

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01 Germany (1)

02 Italy (1)

301MF10046
Via Pavia, 1-27027 Gropello Cairoli...
2019-08-20
2019-08-20
Axplora CB

EMWA 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
218MF10458
Piazzale Luigi Cadorna, 4 - 20123 M...
2006-04-27
2006-04-27
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Looking for 23674-86-4 / Difluprednate API manufacturers, exporters & distributors?

Difluprednate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Difluprednate

Synonyms

23674-86-4, Durezol, Dfba, Myser, Epitopic, [(6s,8s,9r,10s,11s,13s,14s,17r)-17-(2-acetyloxyacetyl)-6,9-difluoro-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] butanoate

Cas Number

23674-86-4

Unique Ingredient Identifier (UNII)

S8A06QG2QE

About Difluprednate

Difluprednate is a topical corticosteroid and prednisolone acetate derivative, with anti-inflammatory activity. Upon instillation into the eye, difluprednate binds to and activates the glucocorticoid receptor (GR). The receptor-ligand complex binds to promoter regions of certain genes and initiates RNA transcription. This results in an induction of synthesis of phospholipase A2 inhibitory proteins, thereby inhibiting the synthesis of arachidonic acid and preventing the synthesis of certain inflammatory mediators, such as prostaglandins and leukotrienes. This reduces ocular inflammation and pain.

Difluprednate Manufacturers

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

Difluprednate Suppliers

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

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

Difluprednate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Difluprednate Drug Master File in Japan (Difluprednate JDMF) empowers Difluprednate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Difluprednate JDMF during the approval evaluation for pharmaceutical products. At the time of Difluprednate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Difluprednate suppliers with JDMF on PharmaCompass.

Difluprednate Manufacturers | Traders | Suppliers

Difluprednate Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Difluprednate

Get in contact with the supplier of your choice:

  1. Axplora
  2. Sicor Societa Italiana Corticosteroidi Srl
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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