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List of Certificates of Suitability (CEPs) for Itraconazole Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 NEULAND LABORATORIES LIMITED Hyderabad IN (1)

02 COHANCE LIFESCIENCES LIMITED Hyderabad IN (1)

03 Choongwae Pharma Corporation Seoul (1)

04 HETERO DRUGS LIMITED Hyderabad IN (1)

05 JANSSEN PHARMACEUTICA NV Beerse BE (2)

06 Janssen Pharmaceutical Ltd County Cork IE (1)

07 LEE PHARMA LIMITED Hyderabad IN (1)

08 MYLAN LABORATORIES LIMITED Hyderabad IN (1)

09 NOSCH LABS PRIVATE LIMITED Hyderabad IN (2)

10 QUIMICA SINTETICA S.A. Alcala De Henares ES (2)

11 SMS PHARMACEUTICALS LIMITED Hyderabad IN (2)

12 STYRAX PHARMA PRIVATE LIMITED Visakhapatnam IN (1)

13 VASUDHA PHARMA CHEM LIMITED Hyderabad IN (1)

14 W. R. GRACE & CO.-CONN. Columbia US (1)

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01 Itraconazole (13)

02 Itraconazole, Bachupally site (1)

03 Itraconazole, Method 1 (1)

04 Itraconazole, Method 2 (alternative synthesis) (1)

05 Itraconazole, Process II (1)

06 Itraconazole, Unit-IV (1)

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01 Belgium (2)

02 India (10)

03 South Korea (1)

04 Spain (2)

05 U.S.A (3)

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01 Expired (3)

02 Valid (13)

03 Withdrawn by Holder (2)

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R1-CEP 2014-165 - Rev 02
Valid
Chemical
2023-04-04
1335
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R1-CEP 1999-196 - Rev 04
Valid
Chemical
2021-07-29
1335
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CEP 2018-173 - Rev 01
Valid
Chemical
2023-10-12
1335
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R1-CEP 2011-283 - Rev 00
Valid
Chemical
2018-05-28
1335
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R1-CEP 1999-139 - Rev 03
Valid
Chemical
2016-12-09
1335
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R1-CEP 2016-006 - Rev 00
Valid
Chemical
2021-04-16
1335
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R1-CEP 2012-403 - Rev 01
Valid
Chemical
2019-09-16
1335
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R0-CEP 2020-265 - Rev 02
Valid
Chemical
2023-02-03
1335
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R1-CEP 2005-269 - Rev 05
Valid
Chemical
2022-09-16
1335
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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 CEP

A Itraconazole CEP of the European Pharmacopoeia monograph is often referred to as a Itraconazole Certificate of Suitability (COS). The purpose of a Itraconazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Itraconazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Itraconazole to their clients by showing that a Itraconazole CEP has been issued for it. The manufacturer submits a Itraconazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Itraconazole CEP holder for the record. Additionally, the data presented in the Itraconazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Itraconazole DMF.

A Itraconazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Itraconazole CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Itraconazole suppliers with CEP (COS) 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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