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List of Drug Master Files (JDMF) for Irbesartan Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 SANOFI WINTHROP INDUSTRIE (1)

02 Active Pharma Co., Ltd. (1)

03 Aurobindo Pharma Limited (1)

04 Daito Co., Ltd. (1)

05 HANMI FINE CHEMICAL CO. , LTD. (1)

06 Hetero Labs Limited (1)

07 LUPIN LIMITED. (1)

08 Mylan Laboratories Limited (1)

09 Shin Poong Pharm. Co. , Ltd. (1)

10 Zhejiang Apeloa Jiayuan Pharmaceutical Co. , Ltd. (1)

11 Zhejiang Huahai Pharmaceutical Co. , Ltd. (1)

12 Zhejiang Tianyu Pharmaceutical Co. , Ltd. (2)

13 Zhuhai Rundu Pharmaceutical Co. , Ltd. (1)

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01 Irbesartan (10)

02 Irbesartan (1)

03 Irbesartan "production-only" (1)

04 Japanese Pharmacopoeia irbesartan (2)

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01 China (5)

02 France (1)

03 India (3)

04 Japan (2)

05 South Korea (2)

06 U.S.A (1)

URL Supplier Web Content
225MF10180
82 Avenue Raspail 94250 Gentilly (F...
2022-06-01
2013-09-18
Sanofi Company Banner

ICRI Spring Convention

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228MF10097
Plot No. 2, Maitrivihar, Ameerpet, ...
2019-09-17
2016-05-16
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228MF10158
326 Yokamachi, Toyama City, Toyama ...
2019-12-20
2016-08-10
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228MF10121
57, Gyeongje-ro, Siheung-si, Gyeong...
2018-09-03
2016-07-01
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228MF10088
161, Yeoksam-ro, Gangnam-gu, Seoul,...
2018-11-12
2016-04-12
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228MF10138
Plot No. 564/A/22, Road No. 92, Jub...
2022-08-31
2016-07-27
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304MF10147
Hengdian Industry Zone, Dongyang, Z...
2022-11-09
2022-11-09
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304MF10158
Jiangkou Development Zone, Huangyan...
2022-12-23
2022-12-23
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URL Supplier Web Content
229MF10089
Jiangkou Development Zone, Huangyan...
2021-06-07
2017-05-01
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301MF10035
No. 6, North Airport Road, Sanzao T...
2019-07-31
2019-07-31
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Irbesartan Drug Master File in Japan (Irbesartan JDMF) empowers Irbesartan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Irbesartan JDMF during the approval evaluation for pharmaceutical products. At the time of Irbesartan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Irbesartan Manufacturers | Traders | Suppliers

Irbesartan 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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