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

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01 BrightGene Pharmaceutical Co., Ltd (1)

02 Cipla Limited (1)

03 Dasan Pharmaceutical Co., Ltd.@[Manufacturer] Shanghai Qingsong Pharmaceutical Co.,Ltd (1)

04 Dongbang FTL Co., Ltd. @Anhui Biochem United Pharmaceutical co., Ltd. (1)

05 Hanseochem Co., Ltd.@[Starting material manufacturer] Wujiang (1)

06 Hetero Drugs Limited (1)

07 Hwail Pharmaceutical Co., Ltd. (1)

08 Ildong Pharmaceutical Co., Ltd. (1)

09 Jeil Pharmaceutical Co., Ltd. @[Second Law Pharmaceutical Manufacturer] Lianyungang Guike Pharmaceutical Co., Ltd. (1)

10 SK Biotek Ireland Limited (1)

11 ST Pharm Co., Ltd. (1)

12 STech Pharma Co., Ltd. (1)

13 Samo Pharmaceutical Co., Ltd. (1)

14 Siegfried Evionnaz S.A. (1)

15 Yeonseong Fine Chemical Co., Ltd. (1)

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01 BMS Korea Pharmaceutical Co., Ltd. (2)

02 Dasan Pharmaceutical Co., Ltd. (1)

03 Donga ST Co., Ltd. (1)

04 Dongbang FTL Co., Ltd. (1)

05 Hanseochem Co., Ltd. (1)

06 Hwail Pharmaceutical Co., Ltd. (1)

07 Ildong Pharmaceutical Co., Ltd. (1)

08 Jeil Pharmaceutical Co., Ltd. (1)

09 Otran Farm Korea Co., Ltd. (1)

10 ST Pharm Co., Ltd. (1)

11 STech Pharma Co., Ltd. (1)

12 Samo Pharmaceutical Co., Ltd. (1)

13 Seongui Bio Co., Ltd. (1)

14 YS Life Science Co., Ltd. (1)

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01 Entecavir (14)

02 entecavir hydrate (1)

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01 China (1)

02 India (2)

03 South Korea (9)

04 Switzerland (1)

05 U.S.A (1)

06 Uzbekistan (1)

URL Supplier Web Content
Otran Farm Korea Co., Ltd.
2017-09-12
Wed21-4-ND
BrightGene Pharmaceutical...
China
No. 218 Xinghu Road, Suzh...
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Donga ST Co., Ltd.
2012-03-16
Number 4838-14-ND(1)
Cipla Limited
India
D-7 MIDC Industrial Area,...
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STech Pharma Co., Ltd.
2012-08-14
1962-4-ND
STech Pharma Co., Ltd.
South Korea
25 Balangongdan-ro, Hyang...
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Hanseochem Co., Ltd.
2011-11-25
787-2-ND
Hanseochem Co., Ltd.@[Sta...
South Korea
41 Poseunggongdan-ro, Pos...
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Seongui Bio Co., Ltd.
2015-07-27
Number 5898-2-ND
Hetero Drugs Limited
India
Sy. No. 213, 214 & 255, B...
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Hwail Pharmaceutical Co., Ltd.
2011-11-18
Number 2417-2-ND
Hwail Pharmaceutical Co.,...
South Korea
57, Jaekongdan 3-gil, Hya...
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Ildong Pharmaceutical Co., Ltd.
2014-05-30
1293-5-ND
Ildong Pharmaceutical Co....
South Korea
53, Gongdan-ro 98beon-gil...
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Flag Uzbekistan
Digital Content Digital Content
URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2012-03-16
711-12-ND
Samo Pharmaceutical Co., ...
South Korea
(429-852) 63, Okgucheonse...
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BMS Korea Pharmaceutical Co., Ltd.
2014-12-03
Number 4095-10-ND
Siegfried Evionnaz S.A.
Switzerland
Route du Simplon 1, 36, 1...
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ST Pharm Co., Ltd.
2013-06-11
1301-2-ND
ST Pharm Co., Ltd.
South Korea
231 Hyeopjeong-ro, Siheun...
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Looking for / Entecavir API manufacturers, exporters & distributors?

Entecavir manufacturers, exporters & distributors 1

21

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

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

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

API | Excipient name

Entecavir

Entecavir Manufacturers

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

Entecavir Suppliers

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

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

Entecavir KDMF

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

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

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

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

Entecavir Manufacturers | Traders | Suppliers

Entecavir 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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