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

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01 Curia Spain S. A. U. (1)

02 Newchem S. p. A. (1)

03 STEROID S. p. A. (1)

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01 Hydrocortisone butyrate (2)

02 Japanese Pharmacopoeia hydrocortisone butyrate (production only) (1)

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01 Italy (2)

02 U.S.A (1)

URL Supplier Web Content
222MF10284
Parque Tecnologico-Parcela 105 Boec...
2020-04-02
2010-12-27
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223MF10022
Via de Amicis 47, 20123 Milano, Ita...
2011-02-08
2011-02-08
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222MF10261
Viale Spagna, 156 Cologno Monzese (...
2010-11-29
2010-11-29
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Looking for 13609-67-1 / Hydrocortisone Butyrate API manufacturers, exporters & distributors?

Hydrocortisone Butyrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Hydrocortisone Butyrate

Synonyms

Hydrocortisone 17-butyrate, Cortisol 17-butyrate, Hydrocortisone-17-butyrate, 13609-67-1, Locoid, Hydrocortisone-17alpha-butyrate

Cas Number

13609-67-1

Unique Ingredient Identifier (UNII)

05RMF7YPWN

About Hydrocortisone Butyrate

Hydrocortisone Butyrate is the butyrate salt form of hydrocortisone, a synthetic glucocorticoid receptor agonist with antiinflammatory, antipruritic and vasoconstrictive effects. Binding and activation of the glucocorticoid receptor results in the activation of lipocortin that in turn inhibits cytosolic phospholipase A2. Lack of phospholipase A2 prevents the release of arachidonic acid, precursor for inflammatory mediator prostaglandins and leukotrienes, from the cell membrane. Secondly, mitogen-activated protein kinase (MAPK) phosphatase 1 is induced, thereby leading to dephosphorylation and inactivation of Jun N-terminal kinase directly inhibiting c-Jun mediated transcription. Finally, transcriptional activity of nuclear factor (NF)-kappa-B is blocked, thereby inhibits the transcription of cyclooxygenase 2, which is essential for prostaglandin production.

Hydrocortisone Butyrate Manufacturers

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

Hydrocortisone Butyrate Suppliers

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

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

Hydrocortisone Butyrate 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 Hydrocortisone Butyrate Drug Master File in Japan (Hydrocortisone Butyrate JDMF) empowers Hydrocortisone Butyrate 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 Hydrocortisone Butyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydrocortisone Butyrate 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 Hydrocortisone Butyrate suppliers with JDMF on PharmaCompass.

Hydrocortisone Butyrate Manufacturers | Traders | Suppliers

Hydrocortisone Butyrate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Hydrocortisone Butyrate

Get in contact with the supplier of your choice:

  1. Curia
  2. NEWCHEM SPA
  3. Steroid SpA
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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