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

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01 Farmabios SpA (1)

02 Ash Stevens LLC (1)

03 Fresenius Kabi Oncology Ltd. (1)

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01 Fresenius Kavi Korea Co., Ltd. (1)

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

03 Pharma Science Korea Co., Ltd. (1)

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01 laying board (3)

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01 Germany (1)

02 Sweden (1)

03 U.S.A (1)

Pharma Science Korea Co., Ltd.
2022-06-08
20220608-210-J-1307
Farmabios SpA
Italy
Via Pavia 1, Gropello Cai...
Axplora CB

Iran Expo

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Korea Otsuka Pharmaceutical Co., Ltd.
2022-09-26
20220926-210-J-1369
Ash Stevens LLC
U.S.A
18655 Krause St., Rivervi...
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URL Supplier Web Content
Fresenius Kavi Korea Co., Ltd.
2018-07-26
20180726-210-J-248
Fresenius Kabi Oncology L...
India
D-35, Industrial Area, Ka...
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Looking for 55-98-1 / Busulfan API manufacturers, exporters & distributors?

Busulfan manufacturers, exporters & distributors 1

70

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

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

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

API | Excipient name

Busulfan

Synonyms

55-98-1, Myleran, Busulphan, Sulphabutin, Leucosulfan, Busulfex

Cas Number

55-98-1

Unique Ingredient Identifier (UNII)

G1LN9045DK

About Busulfan

An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.

Busulfan Manufacturers

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

Busulfan Suppliers

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

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

Busulfan KDMF

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

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

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

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

Busulfan Manufacturers | Traders | Suppliers

Busulfan Manufacturers, Traders, Suppliers 1
79

We have 3 companies offering Busulfan

Get in contact with the supplier of your choice:

  1. Axplora
  2. Ash Stevens, Inc.
  3. Fresenius Kabi AB Brunna
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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