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

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01 Neuland Laboratories (1)

02 ALP Pharm (1)

03 APOTECNIA SA (1)

04 Glenmark Life Sciences (1)

05 Grace (1)

06 Hetero Drugs (1)

07 Johnson & Johnson Innovative Medicine (1)

08 Murli Krishna Pharma (1)

09 Piramal Enterprises Limited (1)

10 Quimica Sintetica S.A. (2)

11 RA CHEM PHARMA LIMITED (1)

12 SIMS Srl (1)

13 SMS Pharmaceuticals (1)

14 Vasudha Pharma Chem (1)

15 Viatris (1)

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01 ITRACONAZOLE (6)

02 ITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE) (1)

03 ITRACONAZOLE (R051211) DRUG SUBSTANCE (1)

04 ITRACONAZOLE PELLETS 22.0 % W/W (1)

05 ITRACONAZOLE USP (6)

06 ITRACONAZOLE USP & PH EUR (1)

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01 China (1)

02 France (1)

03 India (8)

04 Italy (1)

05 Spain (2)

06 U.S.A (3)

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01 Active (10)

02 Inactive (6)

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01 Complete (6)

02 Blank (10)

15445
Active
2001-05-15
Complete
2014-02-12
2013-06-19
II
URL Supplier Web Content
17946
Active
2004-12-29
N/A
II
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12697
Active
1997-10-16
Complete
2018-02-08
2017-12-28
II
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10725
Active
1994-02-18
N/A
II
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27410
Active
2013-08-01
N/A
II
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13012
Active
1998-05-28
Complete
2013-10-31
2013-10-07
II
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25986
Active
2012-04-20
Complete
2013-10-19
2013-03-11
II
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25514
Active
2011-11-22
Complete
2014-04-08
2013-08-13
II
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35261
Active
2020-10-09
N/A
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17739
Active
2004-10-08
Complete
2013-02-27
2013-02-06
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Looking for 84625-61-6 / Itraconazole API manufacturers, exporters & distributors?

Itraconazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Itraconazole

Synonyms

Sporanox, 84625-61-6, Oriconazole, Itrizole (tn), Sporanox (tn), Itcz

Cas Number

84625-61-6

Unique Ingredient Identifier (UNII)

304NUG5GF4

About Itraconazole

A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis.

Itraconazole Manufacturers

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

Itraconazole Suppliers

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

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

Itraconazole USDMF

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

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

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

Itraconazole Manufacturers | Traders | Suppliers

Itraconazole 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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