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

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01 Astellas Pharma Inc. Toyama Technology Center (1)

02 Biocon Limited (1)

03 BrightGene Pharmaceutical Co. Ltd. (1)

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01 Hiple Co., Ltd. (1)

02 Korea Astellas Pharmaceutical Co., Ltd. (1)

03 Otran Farm Korea Co., Ltd. (1)

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01 Sodium micafungin (3)

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01 China (1)

02 India (1)

03 Japan (1)

URL Supplier Web Content
Korea Astellas Pharmaceutical Co., Ltd.
2006-05-11
Number 118-1-ND
Astellas Pharma Inc. Toya...
Japan
2-178, Kojin-machi, Toyam...
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URL Supplier Web Content
Hiple Co., Ltd.
2022-05-25
Number 30-6-ND
Biocon Limited
India
Plot No. 2,3,4 & 5, Phase...
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Otran Farm Korea Co., Ltd.
2019-06-25
Number 695-1-ND
BrightGene Pharmaceutical...
China
Building C25-C28, No.218 ...
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Looking for 208538-73-2 / Micafungin API manufacturers, exporters & distributors?

Micafungin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Micafungin

Synonyms

208538-73-2, Funguard, Mycamine, Fk463 sodium, Fk-463, Micafungin na

Cas Number

208538-73-2

Unique Ingredient Identifier (UNII)

IS1UP79R56

About Micafungin

A cyclic lipo-hexapeptide echinocandin antifungal agent that is used for the treatment and prevention of CANDIDIASIS.

Micafungin Sodium Manufacturers

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

Micafungin Sodium Suppliers

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

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

Micafungin Sodium KDMF

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

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

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

click here to find a list of Micafungin Sodium suppliers with KDMF on PharmaCompass.

Micafungin Sodium Manufacturers | Traders | Suppliers

Micafungin Sodium Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Micafungin Sodium

Get in contact with the supplier of your choice:

  1. Astellas Pharma
  2. Biocon
  3. BrightGene Bio-Medical Technology Co.,Ltd
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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