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

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01 Synbiotics Limited (1)

02 Xellia Pharmaceuticals ApS (2)

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01 Amphotericin B (2)

02 Japanese Pharmacopoeia amphotericin B (1)

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01 Denmark (2)

02 India (1)

URL Supplier Web Content
222MF10230
Plot No. 570,571,576A, Maitry Marg,...
2010-09-16
2010-09-16
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303MF10154
Dalslandsgade 11, DK-2300 Copenhage...
2023-10-04
2021-09-28
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219MF10325
Dalslandsgade 11, DK-2300 Copenhage...
2012-02-09
2007-10-24
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Looking for 1397-89-3 / Amphotericin API manufacturers, exporters & distributors?

Amphotericin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amphotericin

Synonyms

1397-89-3, Amphotericine b, Fungizone, Ambisome, Ampho-moronal, Halizon

Cas Number

1397-89-3

Unique Ingredient Identifier (UNII)

7XU7A7DROE

About Amphotericin

Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.

Amphotericin B Manufacturers

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

Amphotericin B Suppliers

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

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

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

Amphotericin B Manufacturers | Traders | Suppliers

Amphotericin B Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Amphotericin B

Get in contact with the supplier of your choice:

  1. Synbiotics Limited.,
  2. Xellia Pharmaceuticals ApS
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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