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

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01 Teva API (1)

02 Archimica (1)

03 Ash Stevens, Inc. (2)

04 Axitec (1)

05 Bayer AG (2)

06 Biocare Pharmaceutical (1)

07 Explora BioLabs (1)

08 Fred Hutchinson Cancer Center (1)

09 Hubei Biocause Heilen Pharmaceutical Co., Ltd (2)

10 Reliable Biopharmaceutical Corporation (1)

11 Zhejiang Hisun Pharmaceutical (1)

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01 FLUDARA FILM-COATED TABLETS (1)

02 FLUDARABINE PHOSPHATE (6)

03 FLUDARABINE PHOSPHATE (ASP) (1)

04 FLUDARABINE PHOSPHATE (REFINED) (1)

05 FLUDARABINE PHOSPHATE DRUG SUBSTANCE (1)

06 FLUDARABINE PHOSPHATE USP (1)

07 FLUDARABINE PHOSPHATE USP, NON-STERILE BULK DRUG (1)

08 Fludarabine Phosphate Drug Substance (1)

09 MANUFACTURE AND QUALITY CONTROL OF THE BC8-DOTA MONOCLONAL ANTIBODY CONJUGATE (BC8-DOTA) (1)

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01 China (4)

02 Germany (2)

03 Israel (1)

04 Italy (1)

05 Turkey (1)

06 U.S.A (5)

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01 Active (7)

02 Inactive (7)

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01 Complete (3)

02 Blank (11)

URL Supplier Web Content
15742
Active
2001-11-12
Complete
2012-12-24
2012-12-03
II
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15542
Inactive
2001-07-25
N/A
II
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8241
Inactive
1989-10-06
N/A
II
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14924
Inactive
2000-06-15
N/A
II
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35173
Active
2020-09-09
N/A
II
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23006
Active
2009-08-03
N/A
II
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24692
Active
2011-03-01
N/A
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34509
Active
2020-04-29
Complete
2023-01-17
2022-10-29
II
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21047
Active
2007-11-12
N/A
II
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16807
Active
2003-08-27
Complete
2012-12-26
2012-11-15
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Looking for 75607-67-9 / Fludarabine Phosphate API manufacturers, exporters & distributors?

Fludarabine Phosphate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fludarabine Phosphate

Synonyms

75607-67-9, Fludara, Fludarabine 5'-monophosphate, Oforta, Fludarabine monophosphate, 2-fluoro-ara amp

Cas Number

75607-67-9

Unique Ingredient Identifier (UNII)

1X9VK9O1SC

Fludarabine Manufacturers

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

Fludarabine Suppliers

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

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

Fludarabine USDMF

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

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

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

Fludarabine Manufacturers | Traders | Suppliers

Fludarabine Manufacturers, Traders, Suppliers 1
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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