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

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Handok Co., Ltd.
2010-11-16
20101116-133-H-29-02
SANOFI Chimie
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Hanmi Pharmaceutical Co., Ltd.
2013-10-20
20101116-133-H-29-02(1)
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Sanofi-Aventis Korea Co., Ltd.
2013-10-20
20101116-133-H-29-02(2)
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Sanofi-Aventis Korea Co., Ltd.
2016-07-20
20160720-133-H-302-27
EUROAPI Hungary Ltd.
Hungary
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Cheongsol Biotech Co., Ltd.
2011-03-15
20110315-133-H-33-14
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Shinil Pharmaceutical Co., Ltd.
2011-04-14
20101116-133-H-74-01(1)
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2010-11-16
20101116-133-H-74-01
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2011-05-31
20101116-133-H-74-01(2)
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2017-12-26
20130708-133-H-202-23(3)
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Daebong LS Co., Ltd.
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2015-02-25
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Hanmi Fine Chemical Co., Ltd.
2011-01-31
20110131-133-H-131-08
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57 Gyeongje-ro, Siheung-s...
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Masung LS Co., Ltd.
2015-12-07
20151207-133-H-303-26
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Kyungbo Pharmaceutical Co., Ltd.
2010-12-30
20101230-133-H-71-04
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Kyungdong Pharmaceutical Co., Ltd.
2011-01-31
20110131-133-H-133-09
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Pharmacotech Co., Ltd.
2011-02-15
20110215-133-H-104-13
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Shinpoong Pharmaceutical Co., Ltd.
2011-04-14
20110414-133-H-132-16
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7, Wonsi-ro, Danwon-gu, A...
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ST Pharm Co., Ltd.
2011-03-31
20110331-133-H-126-15
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231, Hyeopjeong-ro, Siheu...
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Samo Pharmaceutical Co., Ltd.
2012-08-06
20120806-133-H-212-22
Teva API India Pvt. Ltd
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Samchundang Pharmaceutical Co., Ltd.
2014-04-24
20120806-133-H-212-22(1)
Teva API India Ltd.
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Seil Pharmaceutical Co., Ltd.
2014-06-23
20140623-133-H-260-24
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BC World Pharmaceutical Co., Ltd.
2011-07-15
20110110-133-H-52-05(1)
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Lihu Healthcare Co., Ltd.
2011-01-10
20110110-133-H-52-05
Zhejiang Huahai Pharmaceu...
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Chuannan, Duqiao, Linhai,...
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SG Biochem Co., Ltd.
2021-06-24
20110110-133-H-52-05(2)
Zhejiang Huahai Pharmaceu...
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Inist Farm Co., Ltd.
2014-08-08
20120106-133-H-175-21(5)
Zhejiang Tianyu Pharmaceu...
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Jiangkou Development Zone...
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Kookjeon Pharmaceutical Co., Ltd.
2013-01-09
20120106-133-H-175-21(1)-A
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KMS Pharmaceutical Co., Ltd.
2014-04-11
20120106-133-H-175-21(4)
Zhejiang Tianyu Pharmaceu...
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Jiangkou Development Zone...
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KMS Pharmaceutical Co., Ltd.
2011-06-30
20110429-133-H-68-17(1)
Zhuhai Rundu Pharmaceutic...
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No.6,Airport North Road, ...
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Seongui Bio Co., Ltd.
2016-08-12
20110429-133-H-68-17(3)
Zhuhai Rundu Pharmaceutic...
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No.6, Airpot North Road, ...
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Iksoo Pharmaceutical Co., Ltd.
2011-04-29
20110429-133-H-68-17
Zhuhai Rundu Pharmaceutic...
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  • TABLET;ORAL - 150MG
  • TABLET;ORAL - 300MG
  • TABLET;ORAL - 75MG
  • TABLET;ORAL - 12.5MG;150MG
  • TABLET;ORAL - 12.5MG;300MG
  • TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 138402-11-6 / Irbesartan API manufacturers, exporters & distributors?

Irbesartan manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Irbesartan

Synonyms

138402-11-6, Avapro, Aprovel, Karvea, Sr-47436, Bms-186295

Cas Number

138402-11-6

Unique Ingredient Identifier (UNII)

J0E2756Z7N

About Irbesartan

A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.

Irbesartan Manufacturers

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

Irbesartan Suppliers

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

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

Irbesartan KDMF

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

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

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

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

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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