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

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01 Dipharma Francis Srl (1)

02 JP Laboratories Private Limited (1)

03 Shandong Keyuan Pharmaceutical Co., Ltd. (3)

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01 Hyundai Pharmaceutical Co., Ltd. (1)

02 KR Farm Co., Ltd. (1)

03 Samo Pharmaceutical Co., Ltd. (1)

04 Wooshin Rabotachi Co., Ltd. (2)

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01 Dilute isosorbide mononitrate (4)

02 Isosorbide-5-mononitrate 90% (1)

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01 China (3)

02 India (1)

03 Italy (1)

URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2022-05-04
20220504-209-J-1260
Dipharma Francis Srl
Italy
Via XXIV Maggio 40-33036 ...
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KR Farm Co., Ltd.
2021-11-29
20211129-209-J-654
JP Laboratories Private L...
India
Block A-76, MIDC Chemical...
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Hyundai Pharmaceutical Co., Ltd.
2022-04-05
20220324-209-J-1239(1)
Shandong Keyuan Pharmaceu...
China
Keyuan Street, Shandong S...
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Wooshin Rabotachi Co., Ltd.
2022-03-24
20220324-209-J-1239
Shandong Keyuan Pharmaceu...
China
Keyuan Street, Shandong S...
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Wooshin Rabotachi Co., Ltd.
2021-03-25
20210325-209-J-775
Shandong Keyuan Pharmaceu...
China
Keyuan Street, Shandong S...
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Looking for 16051-77-7 / Isosorbide Mononitrate API manufacturers, exporters & distributors?

Isosorbide Mononitrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Isosorbide Mononitrate

Synonyms

Isosorbide 5-mononitrate, 16051-77-7, Imdur, Corangin, Monosorbitrate, Monoket

Cas Number

16051-77-7

Unique Ingredient Identifier (UNII)

LX1OH63030

About Isosorbide Mononitrate

Isosorbide Mononitrate is the mononitrate salt form of isosorbide, an organic nitrate with vasodilator activity. Isosorbide mononitrate relaxes vascular smooth muscle by formation of the free radical nitric oxide (NO), which is identical to the endothelium-derived relaxing factor (EDRF). NO activates guanylyl cyclase, thereby increasing the synthesis of cGMP within smooth muscle, resulting in dephosphorylation of light chain myosin and relaxation of peripheral arteries and veins. In addition, isosorbide mononitrate relaxes coronary arteries, thereby increasing the blood circulation through the ischemic area. (NCI05)

Isosorbide Mononitrate Manufacturers

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

Isosorbide Mononitrate Suppliers

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

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

Isosorbide Mononitrate KDMF

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

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

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

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

Isosorbide Mononitrate Manufacturers | Traders | Suppliers

Isosorbide Mononitrate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Isosorbide Mononitrate

Get in contact with the supplier of your choice:

  1. Dipharma
  2. JP Laboratories
  3. Shandong Keyuan 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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