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List of Korea Drug Master Files (KDMF) for 012C11ZU6G Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Kyungdong Pharmaceutical Co., Ltd.
2011-06-30
20050831-49-A-99-09(2)
Dr. Reddy's Laboratories ...
India
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Hwail Pharmaceutical Co., Ltd.
2011-06-15
20050831-49-A-99-09(1)
Dr.Reddy's Laboratories L...
India
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Sungwoo Chemical Co., Ltd.
2014-07-07
20050831-49-A-99-09(5)
Dr.Reddy's Laboratories L...
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Hwail Pharmaceutical Co., Ltd.
2005-08-31
20050831-49-A-99-09
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Hanmi Pharmaceutical Co., Ltd.
2012-07-05
20050831-49-A-99-09(4)
Dr.Reddy's Laboratories L...
India
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Kolon Pharmaceutical Co., Ltd.
2022-12-15
20221215-49-A-375-22
Amino Chemicals Ltd
Malta
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Samo Pharmaceutical Co., Ltd.
2005-08-31
20050831-49-A-95-05
Aurobindo Pharma ltd.
India
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Daebong LS Co., Ltd.
2005-08-31
20050831-49-A-88-01
Daebong LS Co., Ltd.
South Korea
(405-820) 123, Neungheoda...
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Novartis Korea Co., Ltd.
2022-12-20
20221220-49-A-376-23
Derivados Quimicos SAU
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GlaxoSmithKline Consumer Healthcare Korea Co., Ltd.
2019-01-18
20190118-49-A-352-20
Derivados Quimicos SAU
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Inist ST Co., Ltd.
2005-08-31
20050831-49-A-89-02
Inist ST Co., Ltd._x000D_
South Korea
500 Sinnae-ro, Geumwang-e...
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Novartis Korea Co., Ltd.
2005-08-31
20050831-49-A-98-08
[Partial process consignm...
Switzerland
[Partial process consignm...
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Inist Farm Co., Ltd.
2015-09-09
20140721-49-A-299-19(1)
Shandong Anhong Pharmaceu...
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No.29 Huayuan Street Liny...
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Shinyoung Biotech Co., Ltd.
2023-06-30
20140721-49-A-299-19(2)
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Kookjeon Pharmaceutical Co., Ltd.
2014-07-21
20140721-49-A-299-19
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Sungjin Exim Co., Ltd.
2012-09-12
20120912-49-A-267-17
Uquifa Mexico Sade CV
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Daesin Pharmaceutical Co., Ltd.
2019-05-13
20190322-49-A-349-21(2)
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HLB Pharmaceutical Co., Ltd.
2020-03-19
20190322-49-A-349-21(8)
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Sungwoo Chemical Co., Ltd.
2019-04-25
20190322-49-A-349-21(1)
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Agerson Bio Co., Ltd.
2021-07-26
20190322-49-A-349-21(11)
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Shinil Pharmaceutical Co., Ltd.
2011-10-28
20050905-49-A-94-10(7)
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Ace Biopharm Co., Ltd.
2019-03-22
20190322-49-A-349-21
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The U Pharmaceutical Co., Ltd.
2022-12-05
20190322-49-A-349-21(12)
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Taegeuk Pharmaceutical Co., Ltd.
2011-06-15
20050905-49-A-94-10(1)
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Wonpoong Pharmaceutical Co., Ltd.
2011-09-23
20050905-49-A-94-10(6)
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IMCD Korea Co., Ltd.
2019-08-02
20190322-49-A-349-21(7)
Zhejiang East-Asia Pharma...
China
Coastal Industrial City, ...
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Daesin Pharmaceutical Co., Ltd.
2011-06-15
20050905-49-A-94-10(3)
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Samo Pharmaceutical Co., Ltd.
2019-07-24
20190322-49-A-349-21(6)
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Toru Co., Ltd.
2019-07-17
20190322-49-A-349-21(5)
Zhejiang East-Asia Pharma...
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Samo Pharmaceutical Co., Ltd.
2005-09-05
20050905-49-A-94-10
Zhejiang East-Asia Pharma...
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Shinil Pharmaceutical Co., Ltd.
2019-06-11
20190322-49-A-349-21(3)
Zhejiang East-Asia Pharma...
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Hiple Co., Ltd.
2021-03-23
20190322-49-A-349-21(9)
Zhejiang East-asia Pharma...
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Coastal Industrial City, ...
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IMCD Korea Co., Ltd.
2011-04-29
20050905-49-A-94-10(2)
Zhejiang East-Asia Pharma...
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Fine Farm Co., Ltd.
2021-03-23
20190322-49-A-349-21(10)
Zhejiang East-asia Pharma...
China
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Hiple Co., Ltd.
2016-07-13
20050905-49-A-94-10(13)
Zhejiang East-Asia Pharma...
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Sungwoo Chemical Co., Ltd.
2011-12-23
20050905-49-A-94-10(8)
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  • TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CREAM;TOPICAL - 1%
  • SOLUTION;TOPICAL - 1%
  • GRANULE;ORAL - EQ 125MG BASE/PACKET
  • GRANULE;ORAL - EQ 187.5MG BASE/PACKET

Looking for 78628-80-5 / Terbinafine Hydrochloride API manufacturers, exporters & distributors?

Terbinafine Hydrochloride manufacturers, exporters & distributors 1

80

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

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

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

API | Excipient name

Terbinafine Hydrochloride

Synonyms

Terbinafine hcl, 78628-80-5, Lamisil at, (e)-n,6,6-trimethyl-n-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride, Bramazil, Bramizil

Cas Number

78628-80-5

Unique Ingredient Identifier (UNII)

012C11ZU6G

About Terbinafine Hydrochloride

A naphthalene derivative that inhibits fungal SQUALENE EPOXIDASE and is used to treat DERMATOMYCOSES of the skin and nails.

012C11ZU6G Manufacturers

A 012C11ZU6G manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 012C11ZU6G, including repackagers and relabelers. The FDA regulates 012C11ZU6G manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 012C11ZU6G 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 012C11ZU6G manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

012C11ZU6G Suppliers

A 012C11ZU6G supplier is an individual or a company that provides 012C11ZU6G active pharmaceutical ingredient (API) or 012C11ZU6G finished formulations upon request. The 012C11ZU6G suppliers may include 012C11ZU6G API manufacturers, exporters, distributors and traders.

click here to find a list of 012C11ZU6G suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

012C11ZU6G KDMF

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

Pharmaceutical companies submit a 012C11ZU6G Drug Master File in Korea (012C11ZU6G KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 012C11ZU6G. The MFDS reviews the 012C11ZU6G KDMF as part of the drug registration process and uses the information provided in the 012C11ZU6G KDMF to evaluate the safety and efficacy of the drug.

After submitting a 012C11ZU6G 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 012C11ZU6G API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 012C11ZU6G suppliers with KDMF on PharmaCompass.

012C11ZU6G Manufacturers | Traders | Suppliers

012C11ZU6G 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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