01 1Hanmi Precision Chemical Co., Ltd.
02 1JDW Pharmaceutical Co., Ltd.
03 1JW Pharmaceutical Co., Ltd. @[Manufacturer of the second method starting material (itraconazole)] Nosch Lab. PVT. LTD Unit-II @[Manufacturer of the third method starting material (itraconazole)] Nosch Lab. PVT. LTD Unit-II @[Manufacturer of the second met
04 2Janssen Pharmaceutica NV
05 1Janssen Pharmaceutical Sciences Unlimited Company
06 3Lee Pharma Limited
07 1Lee Pharma Limited@Lee Pharma Limited
08 1Lee Pharma Limited@[Starting material 'Itraconazole' manufacturing plant] Lee Pharma Limited
09 1NOSCH LABS PRIVATE LIMITED@Nosch Labs Pvt. Ltd (Unit IV)
10 1Nosch Lab. PVT.LTD@Nosch Labs Pvt. Ltd (Unit IV)
11 3Nosch Labs Pvt. Ltd (Unit-II)
12 1Quimica Sintetica SA
13 6SMS Pharmaceuticals Limited
14 2Vasudha Pharma Chem Limited (Unit-III)
01 1Boryeong Co., Ltd.
02 1Daeshin Pharmaceutical Co., Ltd.
03 1Hanmi Precision Chemical Co., Ltd.
04 1Hwail Pharmaceutical Co., Ltd.
05 1IMCD Korea Co., Ltd.
06 3JDW Pharmaceutical Co., Ltd.
07 1Jimax Pharmachem Co., Ltd.
08 4Korea Janssen Co., Ltd.
09 2Lee Sung International Co., Ltd.
10 2Palm East Co., Ltd.
11 2Pharmapia Co., Ltd.
12 2SG Biochem Co., Ltd.
13 1Sanil Pharma Co., Ltd.
14 1Sanil Pharmaceutical Co., Ltd.
15 1Sungwoo Chemical Co., Ltd.
16 1Toru Corporation
01 25Itraconazole
01 18India
02 3South Korea
03 1Spain
04 3U.S.A
Registrant Name : Toru Corporation
Registration Date : 2022-06-13
Registration Number : 20190524-56-A-355-18(2)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Palm East Co., Ltd.
Registration Date : 2021-06-17
Registration Number : 20190529-56-A-356-19(1)
Manufacturer Name : Lee Pharma Limited@Lee Pharm...
Manufacturer Address : Plot No. V, Phase-II, VSEZ, Duvvada, Sabbavaram (M), Visakhapatnam District, Andhra P...
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2019-05-29
Registration Number : 20190529-56-A-356-19
Manufacturer Name : Lee Pharma Limited@[Starting...
Manufacturer Address : Plot No. V, Phase-II, VSEZ, Duvvada, Sabbavaram (M), Visakhapatnam District, Andhra P...
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2019-05-24
Registration Number : 20190524-56-A-355-18
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Palm East Co., Ltd.
Registration Date : 2021-05-14
Registration Number : 20190524-56-A-355-18(1)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2020-06-29
Registration Number : 20070928-56-A-196-14(1)
Manufacturer Name : NOSCH LABS PRIVATE LIMITED@N...
Manufacturer Address : 5-5-35/33/3, Prashanthi nagar, Kukatpally (V&M), Medchal-Malkajgiri (Dist), Hyderabad...
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2016-11-24
Registration Number : 20161124-56-A-324-17
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : C/ Dulcinea s/n, Alcala de Henares 28805 (Madrid), Spain
Registrant Name : Sanil Pharmaceutical Co., Ltd.
Registration Date : 2017-08-03
Registration Number : 20130712-56-A-274-16(5)
Manufacturer Name : SMS Pharmaceuticals Limited
Manufacturer Address : Unit-Ⅱ, Plot No. 24&24B, 36&37, SVCo-operative Industrial Estate, Bachupally, Medch...
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2022-06-23
Registration Number : 20220524-56-A-371-20(1)
Manufacturer Name : Vasudha Pharma Chem Limited ...
Manufacturer Address : Plot No. 23&24, Jawaharlal Nehru Pharma city, Thanam Village, Parawada Mandal, Visakh...
Registrant Name : Jimax Pharmachem Co., Ltd.
Registration Date : 2022-05-24
Registration Number : 20220524-56-A-371-20
Manufacturer Name : Vasudha Pharma Chem Limited ...
Manufacturer Address : Plot No. 23&24, Jawaharlal Nehru Pharma city, Thanam Village, Parawada Mandal, Visakh...
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.
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.
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.
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