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List of Drug Master Files (DMF) of Amphotericin B Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Ajinomoto Company (1)

02 Asence Pharma (3)

03 Bristol Myers Squibb (5)

04 Gilead Sciences (1)

05 North China Pharmaceutical Huasheng Co Ltd (1)

06 Pfizer Inc (1)

07 Xellia Pharmaceuticals ApS (1)

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01 AMBISOME, LIPOSOMAL AMPHOTERICIN B (1)

02 AMPHOTERICIN B (5)

03 AMPHOTERICIN B USP NON-STERILE BULK DRUG (1)

04 AMPHOTERICIN B USP [ORAL GRADE] (1)

05 AMPHOTERICIN B USP [PARENTERAL GRADE] (1)

06 AMPHOTERICIN NON PARENTAL GRADE (1)

07 CRUDE AMPHOTERICIN SLURRY (1)

08 FUNGILIN (AMPHOTERICIN B) ORAL SUSPENSION (1)

09 MANUFACTURE AND CONTROLS (AMPHOTERICIN B, METHYL ESTER) (1)

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01 China (1)

02 Denmark (1)

03 India (3)

04 Japan (1)

05 U.S.A (7)

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01 Active (5)

02 Inactive (8)

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01 Complete (2)

02 Blank (11)

URL Supplier Web Content
13224
Inactive
1998-04-30
N/A
II
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26375
Active
2012-09-05
N/A
II
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26184
Active
2012-06-28
N/A
II
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2578
Inactive
1975-12-17
N/A
II
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10126
Inactive
1987-06-26
N/A
II
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7514
Inactive
1988-06-03
N/A
II
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9564
Active
1992-03-06
N/A
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18157
Active
2005-03-10
Complete
2021-12-16
2021-09-29
II
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13544
Inactive
1998-09-01
N/A
II
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13682
Active
1998-09-01
Complete
2015-02-13
2012-11-19
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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 USDMF

A Amphotericin B DMF (Drug Master File) is a document detailing the whole manufacturing process of Amphotericin B active pharmaceutical ingredient (API) in detail. Different forms of Amphotericin B DMFs exist exist since differing nations have different regulations, such as Amphotericin B USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Amphotericin B DMF submitted to regulatory agencies in the US is known as a USDMF. Amphotericin B USDMF includes data on Amphotericin B's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amphotericin B USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Amphotericin B suppliers with USDMF on PharmaCompass.

Amphotericin B Manufacturers | Traders | Suppliers

Amphotericin B Manufacturers, Traders, Suppliers 1
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We have 7 companies offering Amphotericin B

Get in contact with the supplier of your choice:

  1. Ajinomoto Company
  2. Asence Pharma
  3. Bristol Myers Squibb
  4. Gilead Sciences
  5. North China Pharmaceutical Huasheng Co Ltd
  6. Pfizer Inc
  7. 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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