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

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Looking for 138614-30-9 / Icatibant Acetate API manufacturers, exporters & distributors?

Icatibant Acetate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Icatibant Acetate

Synonyms

Icatibant acetate [usan], Icatibant (acetate), Firazyr, 325o8467xk, 138614-30-9, (r)-arginyl-(s)-arginyl-(s)-prolyl-(2s,4r)-(4-hydroxyprolyl)glycyl-(s)-(3-(2-thienyl)alanyl)-(s)-seryl-(r)-((1,2,3,4-tetrahydro-3-isoquinolyl)carbonyl)-(2s,3as,7as)-((hexahydro-2-indolinyl)carbonyl)-(s)-arginine acetate (salt)

Cas Number

138614-30-9

Unique Ingredient Identifier (UNII)

325O8467XK

About Icatibant Acetate

Icatibant Acetate is the acetate salt form of icatibant, an antagonist of the human bradykinin B2 receptor (B2R), that can be used for the treatment of hereditary angioedema (HAE). Upon administration, icatibant targets and binds to B2R, thereby preventing bradykinin from binding to the B2R. This may prevent bradykinin/B2R-mediated vasodilation, the resulting increase in vascular permeability, and the swelling, inflammation, and pain associated with HAE. This may also prevent or improve pulmonary edema not associated with HAE and improve the associated decrease in blood oxygen levels.

Icatibant Manufacturers

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

Icatibant Suppliers

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

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

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

Icatibant Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Bachem AG
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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