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List of Korea Drug Master Files (KDMF) for NCGC00025000-06 Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Daesin Pharmaceutical Co., Ltd.
2012-10-05
20121005-167-I-1-03
Aarti Drugs Limited
India
Plot No. E-21, MIDC, Tara...
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Seongui Bio Co., Ltd.
2013-05-30
20121005-167-I-1-03(1)
Aarti Drugs Limited
India
Plot No. E-21, MIDC, Tara...
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Huons Co., Ltd.
2012-08-14
20120814-167-I-49-02
Janssen Pharmaceutica N.V...
Belgium
Janssen Pharmaceuticalaan...
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Huons Co., Ltd.
2022-01-10
20220110-167-I-630-07
Piramal Pharma Limited
India
Sy. Nos. 7-70, 70/1 and 7...
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Pharmapia Co., Ltd.
2012-04-13
20120413-167-I-46-01
Sharon Bio-Medicine Ltd.
India
Plot No. L-6, MIDC-Taloja...
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Pharmapia Co., Ltd.
2019-04-23
20190111-167-I-565-06(1)
Zhejiang East-asia Pharma...
China
Coastal Industrial City, ...
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Hiple Co., Ltd.
2013-05-22
20130522-167-I-135-04
Zhejiang East-Asia Pharma...
China
Economic Development Zone...
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Sungwoo Chemical Co., Ltd.
2013-11-18
20130522-167-I-135-04(2)
Zhejiang East-Asia Pharma...
China
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Toru Co., Ltd.
2019-07-17
20190111-167-I-565-06(2)
Zhejiang East-Asia Pharma...
China
Coastal Industrial City, ...
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QI Trading Co., Ltd.
2017-08-09
20130522-167-I-135-04(3)
Zhejiang East-Asia Pharma...
China
Economic Development Zone...
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IMCD Korea Co., Ltd.
2013-10-29
20130522-167-I-135-04(1)
Zhejiang East-Asia Pharma...
China
Economic Development Zone...
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JSP Co., Ltd.
2019-06-25
20130522-167-I-135-04(6)
Zhejiang East-Asia Pharma...
China
Economic Development Zone...
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Ace Biopharm Co., Ltd.
2019-01-11
20190111-167-I-565-06
Zhejiang East-Asia Phamac...
China
Coastal Industrial City, ...
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Pharmapia Co., Ltd.
2017-05-23
20130522-167-I-135-04(5)
Zhejiang East-Asia Pharma...
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  • TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SHAMPOO;TOPICAL - 1%
  • AEROSOL, FOAM;TOPICAL - 2%
  • GEL;TOPICAL - 2%

Looking for 65277-42-1 / Ketoconazole API manufacturers, exporters & distributors?

Ketoconazole manufacturers, exporters & distributors 1

34

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

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

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

API | Excipient name

Ketoconazole

Synonyms

(+)-ketoconazole, 65277-42-1, (2r,4s)-ketoconazole, 142128-59-4, Kuric, Ketocanazole

Cas Number

65277-42-1

About Ketoconazole

Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.

NCGC00025000-06 Manufacturers

A NCGC00025000-06 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00025000-06, including repackagers and relabelers. The FDA regulates NCGC00025000-06 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00025000-06 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 NCGC00025000-06 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

NCGC00025000-06 Suppliers

A NCGC00025000-06 supplier is an individual or a company that provides NCGC00025000-06 active pharmaceutical ingredient (API) or NCGC00025000-06 finished formulations upon request. The NCGC00025000-06 suppliers may include NCGC00025000-06 API manufacturers, exporters, distributors and traders.

click here to find a list of NCGC00025000-06 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

NCGC00025000-06 KDMF

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

Pharmaceutical companies submit a NCGC00025000-06 Drug Master File in Korea (NCGC00025000-06 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NCGC00025000-06. The MFDS reviews the NCGC00025000-06 KDMF as part of the drug registration process and uses the information provided in the NCGC00025000-06 KDMF to evaluate the safety and efficacy of the drug.

After submitting a NCGC00025000-06 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 NCGC00025000-06 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of NCGC00025000-06 suppliers with KDMF on PharmaCompass.

NCGC00025000-06 Manufacturers | Traders | Suppliers

NCGC00025000-06 Manufacturers, Traders, Suppliers 1
52

We have 5 companies offering NCGC00025000-06

Get in contact with the supplier of your choice:

  1. Aarti Drugs
  2. Johnson & Johnson Innovative Medicine
  3. Piramal Pharma Solutions
  4. Sharon Bio-Medicine Limited
  5. Zhejiang Medicine Co Ltd
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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