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

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01 Farmabios SPA@MICROCHEM SRL (1)

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01 Samil Pharmaceutical Co., Ltd. (1)

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01 Micronized fludrocortisone acetate (1)

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01 Germany (1)

Samil Pharmaceutical Co., Ltd.
2021-12-02
20211202-209-J-1149
Farmabios SPA@MICROCHEM S...
Germany
Via Pavia 1 - 27027 Grope...
Axplora CB

India Med Expo

Not Confirmed

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Looking for 514-36-3 / Fludrocortisone Acetate API manufacturers, exporters & distributors?

Fludrocortisone Acetate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fludrocortisone Acetate

Synonyms

514-36-3, Scherofluron, Cortineff, Fludrocortisone 21-acetate, Florinef acetate, Alflorone acetate

Cas Number

514-36-3

Unique Ingredient Identifier (UNII)

V47IF0PVH4

About Fludrocortisone Acetate

Fludrocortisone Acetate is the acetate salt of a synthetic fluorinated corticosteroid with antiinflammatory and antiallergic activities. As a glucocorticoid-receptor agonist, fludrocortisone binds to cytoplasmic receptors, translocates to the nucleus, and subsequently initiates the transcription of glucocorticoid-responsive genes such as lipocortins to inhibit phospholipase A2 (PLA2). Inhibition of PLA2 activity prevents the release of arachidonic acid, a precursor of eicosanoids such as prostaglandins and leukotrienes; eicosanoids are important mediators in the pro-inflammatory response mechanism. As a mineralocorticoid-receptor agonist, this agent stimulates Na+ reabsorption and water retention and K+ and H+ secretion in the distal tubules and collecting ducts of the kidney.

Fludrocortisone Manufacturers

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

Fludrocortisone Suppliers

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

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

Fludrocortisone KDMF

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

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

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

click here to find a list of Fludrocortisone suppliers with KDMF on PharmaCompass.

Fludrocortisone Manufacturers | Traders | Suppliers

Fludrocortisone Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Fludrocortisone

Get in contact with the supplier of your choice:

  1. Axplora
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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