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

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01 Ami Lifesciences Private Limited (1)

02 Ami Lifesciences Pvt. Ltd. (1)

03 HK InnoN Co., Ltd. @ST Pharm Co., Ltd. (1)

04 HK Innoen Co., Ltd. (1)

05 Lee Pharma Limited (2)

06 Ruyuan HEC Pharma Co., Ltd. (1)

07 SPC Co., Ltd.@Dasan Pharmaceutical Co., Ltd. (1)

08 Wisdom Pharmaceutical Co., Ltd. (1)

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01 Dasan Pharmaceutical Co., Ltd. (1)

02 HK Innoen Co., Ltd. (3)

03 Hiple Co., Ltd. (2)

04 Iksoo Pharmaceutical Co., Ltd. (1)

05 Kyungdong Pharmaceutical Co., Ltd. (1)

06 Leesung International Co., Ltd. (1)

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01 Tegoprazan (9)

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01 China (2)

02 India (4)

03 South Korea (2)

04 Blank (1)

URL Supplier Web Content
Kyungdong Pharmaceutical Co., Ltd.
2024-01-19
Soo69-17-ND(1)
Ami Lifesciences Private ...
India
Block No. 82/B, ECP Road ...
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Iksoo Pharmaceutical Co., Ltd.
2023-08-18
Wed69-17-ND
Ami Lifesciences Pvt. Ltd...
India
Block No. 82/B, ECP Road,...
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Hiple Co., Ltd.
2023-12-11
Wed30-7-ND
Ruyuan HEC Pharma Co., Lt...
China
Xiaba Development Zone, R...
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HK Innoen Co., Ltd.
2021-04-16
1452-6-ND
HK Innoen Co., Ltd.
South Korea
20 Daesosandan-ro, Daeso-...
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HK Innoen Co., Ltd.
2021-10-18
1452-7-ND
HK InnoN Co., Ltd. @ST Ph...
South Korea
20 Daesosandan-ro, Daeso-...
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URL Supplier Web Content
Hiple Co., Ltd.
2024-02-23
Wed21-25-ND(1)
Lee Pharma Limited
India
Survey No.10/G-1, Gaddapo...
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Leesung International Co., Ltd.
2024-01-19
Wed21-25-ND
Lee Pharma Limited
India
Survey No.10/G-1, Gaddapo...
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HK Innoen Co., Ltd.
2018-06-11
Wed 1452-5-ND
Wisdom Pharmaceutical Co....
China
No. 18, Qinghua Road, San...
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Dasan Pharmaceutical Co., Ltd.
2024-01-15
2243-13-ND
SPC Co., Ltd.@Dasan Pharm...
South Korea
386 Pyeongtaekhangman-gil...
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Looking for 942195-55-3 / Tegoprazan API manufacturers, exporters & distributors?

Tegoprazan manufacturers, exporters & distributors 1

26

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

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

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

API | Excipient name

Tegoprazan

Synonyms

942195-55-3, Tegoprazan [inn], W017g7if4s, Lxi-15028, (s)-4-((5,7-difluorochroman-4-yl)oxy)-n,n,2-trimethyl-1h-benzo[d]imidazole-6-carboxamide, 1h-benzimidazole-5-carboxamide, 7-(((4s)-5,7-difluoro-3,4-dihydro-2h-1-benzopyran-4-yl)oxy)-n,n,2-trimethyl-

Cas Number

942195-55-3

Unique Ingredient Identifier (UNII)

W017G7IF4S

About Tegoprazan

Tegoprazan (also known as CJ-12420) is a novel therapeutic developed by CJ Healthcare Corp for treating acid-related gastrointestinal diseases. This drug is a potent and high-selective potassium-competitive acid blocker (P-CAB) with a fast onset of action and the ability to control gastric pH for a prolonged period of time. Tegoprazans strong and sustained effect is due to its ability to be slowly cleared from the gastric glands and exertion of effects independent of acid levels. It has also been observed to be efficacious independent of food intake.

Tegoprazan Manufacturers

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

Tegoprazan Suppliers

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

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

Tegoprazan KDMF

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

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

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

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

Tegoprazan Manufacturers | Traders | Suppliers

Tegoprazan Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Tegoprazan

Get in contact with the supplier of your choice:

  1. Ami Lifesciences Private Limited
  2. HEC Pharm
  3. HK inno.N
  4. Lee Pharma
  5. Wisdom Pharmaceutical 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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