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

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01 Dr. Reddy's Laboratories Limited (1)

02 Dr.Reddy's Laboratories Ltd (1)

03 Dr.Reddy's Laboratories Ltd. (3)

04 Amino Chemicals Ltd (1)

05 Aurobindo Pharma ltd. (1)

06 Daebong LS Co., Ltd. (1)

07 Derivados Quimicos SAU (2)

08 Inist ST Co., Ltd._x000D_ (1)

09 Shandong Anhong Pharmaceutical Co., Ltd. (2)

10 Shandong Anhong Pharmaceutical Co., Ltd. (formerly Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.) (1)

11 Uquifa Mexico Sade CV (1)

12 Zhejiang East-Asia Pharmaceutical Chemical Co., Ltd (2)

13 Zhejiang East-Asia Pharmaceutical Chemical Co.,Ltd. (1)

14 Zhejiang East-Asia Pharmaceutical Co., Ltd (1)

15 Zhejiang East-Asia Pharmaceutical Co., Ltd, (1)

16 Zhejiang East-Asia Pharmaceutical Co., Ltd. (9)

17 Zhejiang East-Asia Pharmaceutical Co., Ltd._x000D_ (2)

18 Zhejiang East-asia Pharmaceutical Co., Ltd. Ltd. (4)

19 [Partial process consignment manufacturing (manufacturing requester)] Novartis Pharma AG@[Partial process consignment manufacturing (manufacturer)] Novartis Ringaskiddy Ltd@[Partial process consignment manufacturing (manufacturer)] Novartis Pharma Stein A (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Agerson Bio Co., Ltd. (1)

03 Daebong LS Co., Ltd. (1)

04 Daesin Pharmaceutical Co., Ltd. (2)

05 Fine Farm Co., Ltd. (1)

06 GlaxoSmithKline Consumer Healthcare Korea Co., Ltd. (1)

07 HLB Pharmaceutical Co., Ltd. (1)

08 Hanmi Pharmaceutical Co., Ltd. (1)

09 Hiple Co., Ltd. (2)

10 Hwail Pharmaceutical Co., Ltd. (2)

11 IMCD Korea Co., Ltd. (2)

12 Inist Farm Co., Ltd. (1)

13 Inist ST Co., Ltd. (1)

14 Kolon Pharmaceutical Co., Ltd. (1)

15 Kookjeon Pharmaceutical Co., Ltd. (1)

16 Kyungdong Pharmaceutical Co., Ltd. (1)

17 Novartis Korea Co., Ltd. (2)

18 Samo Pharmaceutical Co., Ltd. (3)

19 Shinil Pharmaceutical Co., Ltd. (2)

20 Shinyoung Biotech Co., Ltd. (1)

21 Sungjin Exim Co., Ltd. (1)

22 Sungwoo Chemical Co., Ltd. (3)

23 Taegeuk Pharmaceutical Co., Ltd. (1)

24 The U Pharmaceutical Co., Ltd. (1)

25 Toru Co., Ltd. (1)

26 Wonpoong Pharmaceutical Co., Ltd. (1)

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01 Terbinafine hydrochloride (36)

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01 China (23)

02 India (6)

03 Malta (1)

04 South Korea (2)

05 Spain (3)

06 Switzerland (1)

Sungwoo Chemical Co., Ltd.
2014-07-07
20050831-49-A-99-09(5)
Dr.Reddy's Laboratories L...
India
Unit-III, Plot No. 116, S...
Kyungdong Pharmaceutical Co., Ltd.
2011-06-30
20050831-49-A-99-09(2)
Dr. Reddy's Laboratories ...
India
Unit-III, Plot No. 116, S...
Hwail Pharmaceutical Co., Ltd.
2011-06-15
20050831-49-A-99-09(1)
Dr.Reddy's Laboratories L...
India
Unit-III, Plot No. 116, S...
Hwail Pharmaceutical Co., Ltd.
2005-08-31
20050831-49-A-99-09
Dr.Reddy's Laboratories L...
India
Unit-III, Plot No. 116, S...
Hanmi Pharmaceutical Co., Ltd.
2012-07-05
20050831-49-A-99-09(4)
Dr.Reddy's Laboratories L...
India
Unit-III, Plot No. 116, S...
URL Supplier Web Content
Kolon Pharmaceutical Co., Ltd.
2022-12-15
20221215-49-A-375-22
Amino Chemicals Ltd
Malta
MRA 050X Industrial Estat...
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URL Supplier Web Content
Novartis Korea Co., Ltd.
2022-12-20
20221220-49-A-376-23
Derivados Quimicos SAU
Spain
Camino Viejo de Pliego, s...
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Shinyoung Biotech Co., Ltd.
2023-06-30
20140721-49-A-299-19(2)
Shandong Anhong Pharmaceu...
China
No.29 Huayuan Street Liny...
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Agerson Bio Co., Ltd.
2021-07-26
20190322-49-A-349-21(11)
Zhejiang East-asia Pharma...
China
Coastal Industrial City, ...
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The U Pharmaceutical Co., Ltd.
2022-12-05
20190322-49-A-349-21(12)
Zhejiang East-asia Pharma...
China
Coastal Industrial City, ...
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Looking for 78628-80-5 / Terbinafine Hydrochloride API manufacturers, exporters & distributors?

Terbinafine Hydrochloride manufacturers, exporters & distributors 1

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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.

Terbinafine Hydrochloride Manufacturers

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

Terbinafine Hydrochloride Suppliers

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

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

Terbinafine Hydrochloride KDMF

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

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

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

click here to find a list of Terbinafine Hydrochloride suppliers with KDMF on PharmaCompass.

Terbinafine Hydrochloride Manufacturers | Traders | Suppliers

Terbinafine Hydrochloride 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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