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

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01 Daewoong Bio Co., Ltd. (2)

02 Hanmi Fine Chemical Co., Ltd. (1)

03 JW Pharmaceutical Co., Ltd. (1)

04 JW Pharmaceutical Co., Ltd. @[Manufacturer of method 2 starting material (itraconazole)] Nosch Lab. P.V.T. LTD@[Process 3 starting material (itraconazole) manufacturer] Nosch Lab. P.V.T. LTD (1)

05 Janssen Pharmaceutica N.V. (2)

06 Janssen Pharmaceutical Sciences Unlimited Company (1)

07 Lee Pharma Limited (3)

08 Lee Pharma Limited@Lee Pharma Limited (1)

09 Lee Pharma Limited@[Manufactory of starting material 'itraconazole'] Lee Pharma Limited (1)

10 NOSCH LABS PRIVATE LIMITED@Nosch Labs Pvt. Ltd (Unit IV) (1)

11 Nosch Lab. P.V.T. LTD (1)

12 Nosch Lab. PVT.LTD (2)

13 Nosch Lab. PVT.LTD@Nosch Labs Pvt. Ltd (Unit IV) (1)

14 Quimica Sintetica S.A. (1)

15 SMS Pharmaceuticals Limited (6)

16 Vasudha Pharma Chem Limited (Unit-III) (2)

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01 Boryeong Co., Ltd. (1)

02 Daesin Pharmaceutical Co., Ltd. (1)

03 Daewoong Bio Co., Ltd. (2)

04 Farm East Co., Ltd. (2)

05 GMAX Pharmachem Co., Ltd. (1)

06 Hanmi Fine Chemical Co., Ltd. (1)

07 Hwail Pharmaceutical Co., Ltd. (1)

08 IMCD Korea Co., Ltd. (1)

09 JW Pharmaceutical Co., Ltd. (3)

10 Korea Janssen Co., Ltd. (4)

11 Leesung International Co., Ltd. (2)

12 Pharmapia Co., Ltd. (2)

13 SG Biochem Co., Ltd. (2)

14 Sanil Pharma Co., Ltd. (1)

15 Sanil Pharmaceutical Co., Ltd. (1)

16 Sungwoo Chemical Co., Ltd. (1)

17 Toru Co., Ltd. (1)

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01 Itraconazole (27)

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01 India (18)

02 South Korea (5)

03 Spain (1)

04 U.S.A (3)

URL Supplier Web Content
Farm East Co., Ltd.
2021-05-14
20190524-56-A-355-18(1)
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Toru Co., Ltd.
2022-06-13
20190524-56-A-355-18(2)
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Farm East Co., Ltd.
2021-06-17
20190529-56-A-356-19(1)
Lee Pharma Limited@Lee Ph...
India
Plot No. V, Phase-II, VSE...
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SG Biochem Co., Ltd.
2019-05-29
20190529-56-A-356-19
Lee Pharma Limited@[Manuf...
India
Plot No. V, Phase-II, VSE...
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SG Biochem Co., Ltd.
2019-05-24
20190524-56-A-355-18
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Sungwoo Chemical Co., Ltd.
2020-06-29
20070928-56-A-196-14(1)
NOSCH LABS PRIVATE LIMITE...
India
5-5-35/33/3, Prashanthi n...
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Boryeong Co., Ltd.
2016-11-24
20161124-56-A-324-17
Quimica Sintetica S.A.
Spain
C/ Dulcinea s/n, Alcala d...
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Sanil Pharmaceutical Co., Ltd.
2017-08-03
20130712-56-A-274-16(5)
SMS Pharmaceuticals Limit...
India
Unit-Ⅱ, Plot No. 24&24B...
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Korea Janssen Co., Ltd.
2022-06-23
20220524-56-A-371-20(1)
Vasudha Pharma Chem Limit...
India
Plot No. 23&24, Jawaharla...
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GMAX Pharmachem Co., Ltd.
2022-05-24
20220524-56-A-371-20
Vasudha Pharma Chem Limit...
India
Plot No. 23&24, Jawaharla...
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Looking for 84625-61-6 / Itraconazole API manufacturers, exporters & distributors?

Itraconazole manufacturers, exporters & distributors 1

64

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 KDMF

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

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

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

click here to find a list of Itraconazole suppliers with KDMF 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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