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

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01 North China Pharmaceutical Huasheng Co., Ltd. (1)

02 Xellia Pharmaceuticals ApS (2)

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01 DKSH Korea Co., Ltd. (1)

02 Gilead Sciences Korea Ltd. (1)

03 Hiple Co., Ltd. (1)

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01 Amphoteric Mystery (2)

02 Amphotericin B (1)

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01 China (1)

02 Denmark (2)

URL Supplier Web Content
Hiple Co., Ltd.
2023-06-08
20230608-210-J-1507
North China Pharmaceutica...
China
No.8 Yangzi Road, Shijiaz...
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DKSH Korea Co., Ltd.
2020-10-13
20200727-210-J-391(1)
Xellia Pharmaceuticals Ap...
Denmark
Dalslandsgade 11, Kobenha...
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Gilead Sciences Korea Ltd.
2020-07-27
20200727-210-J-391
Xellia Pharmaceuticals Ap...
Denmark
Dalslandsgade 11, Kobenha...
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Looking for 1397-89-3 / Amphotericin API manufacturers, exporters & distributors?

Amphotericin manufacturers, exporters & distributors 1

17

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 KDMF

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

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

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

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

Amphotericin B Manufacturers | Traders | Suppliers

Amphotericin B Manufacturers, Traders, Suppliers 1
73

We have 2 companies offering Amphotericin B

Get in contact with the supplier of your choice:

  1. North China Pharmaceutical Huasheng Co Ltd
  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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