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

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Flag Poland
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Kookjeon Pharmaceutical Co., Ltd.
2014-02-27
20130117-170-I-185-05(4)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str. 83-20...
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Myungin Pharmaceutical Co., Ltd.
2020-01-13
20130117-170-I-185-05(6)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
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Wooshin Rabotachi Co., Ltd.
2013-01-17
20130117-170-I-185-05
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str. 83-20...
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Huons Co., Ltd.
2013-04-10
20130117-170-I-185-05(3)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str. 83-20...
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Ace Biopharm Co., Ltd.
2016-12-07
20130912-170-I-365-10(2)
Bal Pharma Limited
India
No.61-B, Bommasandra Indu...
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Hiple Co., Ltd.
2013-09-12
20130912-170-I-365-10
Bal Pharma Limited
India
No. 61-B, Bommasandra Ind...
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Pharma Science Korea Co., Ltd.
2022-08-31
20110902-170-I-9-08(4)
Cipla Limited
India
Virgonagar Post, Old Madr...
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Unimed Pharmaceutical Co., Ltd.
2012-11-28
20110902-170-I-9-08(1)
Cipla Limited
India
Virgonagar Post, Old Madr...
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Hallym Pharmaceutical Co., Ltd.
2013-03-22
20110902-170-I-9-08(2)
Cipla Limited
India
Virgonagar Post, Old Madr...
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UNUST Co., Ltd.
2011-09-02
20110902-170-I-9-08
Cipla Limited
India
Virgonagar Post, Old Madr...
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STech Pharma Co., Ltd.
2013-01-29
20130129-170-I-321-01
STech Pharma Co., Ltd.
South Korea
(445-938) 25 Balangongdan...
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Seongui Bio Co., Ltd.
2016-11-24
20161124-170-I-496-17
Hetero Drugs Limited
India
Sy. No. 213, 214, & 255, ...
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Hansol Pharma Co., Ltd.
2017-08-03
20161124-170-I-496-17(1)
Hetero Drugs Limited
India
Sy. No. 213, 214, & 255, ...
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HLGnomics Co., Ltd.
2013-12-20
20131220-170-I-387-11
HLGnomics Co., Ltd.
South Korea
1552, Bogaewonsam-ro, Won...
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Ildong Pharmaceutical Co., Ltd.
2012-12-28
20121228-170-I-207-04
Ildong Pharmaceutical Co....
South Korea
53 Gongdan-ro 98beon-gil,...
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Korea Janssen Co., Ltd.
2012-09-07
20120907-170-I-44-03
Janssen Pharmaceuticals I...
U.S.A
1440 Olympic Drive, Athen...
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Ace Biopharm Co., Ltd.
2017-09-05
20160713-170-I-472-16(1)
Nifty Labs Pvt.,Ltd.
India
Plot No. 50-A, B, G & H, ...
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Ace Biopharm Co., Ltd.
2016-07-13
20160713-170-I-472-16
Nifty Labs Pvt., Ltd.
India
Plot No. 50-A, B, G & H, ...
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Alvogen Korea Co., Ltd.
2019-05-30
20190530-170-I-277-19
ScinoPharm Taiwan, Ltd.
Taiwan
No.1, Nan-Ke 8th Road Sha...
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Korea Janssen Co., Ltd.
2015-05-15
20150515-170-I-446-14
Siegfried Ltd.
Switzerland
Untere Bruhlstrasse 4, 48...
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Masung LS Co., Ltd.
2015-08-27
20150827-170-I-457-15
Signa S.A. de C.V.
Mexico
Av. Industria Automotriz ...
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ST Pharm Co., Ltd.
2014-12-09
20141209-170-I-420-12
ST Pharm Co., Ltd.
South Korea
171 Haean-ro, Danwon-gu, ...
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Hanmi Pharmaceutical Co., Ltd.
2013-08-12
20130329-170-I-181-06(5)
Sun Pharmaceutical Indust...
India
Plot No. 24/2 & 25, Phase...
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Samo Pharmaceutical Co., Ltd.
2013-03-29
20130329-170-I-181-06
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -Ⅳ, ...
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Seoul Pharmaceutical Co., Ltd.
2013-07-12
20130329-170-I-181-06(3)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -IV, G...
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Alvogen Korea Co., Ltd.
2013-07-12
20130329-170-I-181-06(4)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase - IV, ...
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Bahnsen Co., Ltd.
2018-10-23
20130329-170-I-181-06(8)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -Ⅳ, ...
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Hwanin Pharmaceutical Co., Ltd.
2013-06-04
20130329-170-I-181-06(2)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -Ⅳ, ...
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Kookjeon Pharmaceutical Co., Ltd.
2014-08-25
20130329-170-I-181-06(6)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -Ⅳ, ...
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Unimed Pharmaceutical Co., Ltd.
2013-05-21
20130329-170-I-181-06(1)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -Ⅳ, ...
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The One Farmtech Co., Ltd.
2022-05-22
20130329-170-I-181-06(9)
Sun Pharmaceutical Indust...
India
Plot No. 25, Phase -Ⅳ, ...
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Pharma Science Korea Co., Ltd.
2015-04-09
20150409-170-I-438-13
Therapiva Private Limited
India
TU-Ⅱ, Plot No. 9/A, Pha...
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Samo Pharmaceutical Co., Ltd.
2017-09-04
20170803-170-I-513-18(1)
Cadila Healthcare Limited
India
Plot No. 26 to 29 & 31, D...
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SK Chemicals Co., Ltd.
2017-08-03
20170803-170-I-513-18
Zydus Lifescience Limited
India
Plot No.26 to 29 & 31, Da...
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  • TABLET;ORAL - 100MG
  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 25MG
  • TABLET;ORAL - 50MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 100MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 150MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 200MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 25MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 50MG

Looking for 97240-79-4 / Topiramate API manufacturers, exporters & distributors?

Topiramate manufacturers, exporters & distributors 1

71

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

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

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

API | Excipient name

Topiramate

Synonyms

97240-79-4, Topamax, Epitomax, Topamax sprinkle, Topina, Mcn-4853

Cas Number

97240-79-4

Unique Ingredient Identifier (UNII)

0H73WJJ391

About Topiramate

A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.

Topiramate Manufacturers

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

Topiramate Suppliers

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

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

Topiramate KDMF

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

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

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

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

Topiramate Manufacturers | Traders | Suppliers

Topiramate 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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