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

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01 DIPHARMA FRANCIS srl (1)

02 Dipharma Francis Srl (2)

03 Dipharma Francis Srl@Adare Pharmaceuticals srl (1)

04 Dottikon Exclusive Synthesis AG (2)

05 JP Laboratories Private Limited (1)

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01 Bukwang Pharmaceutical Co., Ltd. (1)

02 Ellison Pharmaceutical Co., Ltd. (2)

03 KR Farm Co., Ltd. (1)

04 Kolon Pharmaceutical Co., Ltd. (1)

05 Korea Unifarm Co., Ltd. (1)

06 Samo Pharmaceutical Co., Ltd. (1)

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01 Dilute isosorbide dinitrate (3)

02 Isosorbide dinitrate (4)

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01 India (1)

02 Italy (4)

03 Switzerland (2)

URL Supplier Web Content
Bukwang Pharmaceutical Co., Ltd.
2021-12-07
20211207-209-J-1172
Dipharma Francis Srl@Adar...
Italy
33036, Via XXIV Maggio, 4...
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Samo Pharmaceutical Co., Ltd.
2022-08-25
20220825-209-J-1350
Dipharma Francis Srl
Italy
Via XXIV Maggio 40-33036 ...
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Ellison Pharmaceutical Co., Ltd.
2023-01-06
20220825-209-J-1350(1)
Dipharma Francis Srl
Italy
Via XXIV Maggio 40-33036 ...
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Ellison Pharmaceutical Co., Ltd.
2022-12-14
20221214-209-J-1421
DIPHARMA FRANCIS srl
Italy
Via XXIV Maggio 40, 33036...
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Korea Unifarm Co., Ltd.
2020-08-28
20200828-209-J-668
Dottikon Exclusive Synthe...
Switzerland
Hembrunnstrasse 17 5605 D...
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Kolon Pharmaceutical Co., Ltd.
2021-03-25
20200828-209-J-668(1)
Dottikon Exclusive Synthe...
Switzerland
Hembrunnstrasse 17 CH-560...
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KR Farm Co., Ltd.
2022-09-28
20220928-209-J-1370
JP Laboratories Private L...
India
Block A-76, MIDC Chemical...
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Looking for 87-33-2 / Isosorbide Dinitrate API manufacturers, exporters & distributors?

Isosorbide Dinitrate manufacturers, exporters & distributors 1

33

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

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

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

API | Excipient name

Isosorbide Dinitrate

Synonyms

87-33-2, Isordil, Sorbide nitrate, Sorbidnitrate, Nitrosorbide, Sorbitrate

Cas Number

87-33-2

Unique Ingredient Identifier (UNII)

IA7306519N

About Isosorbide Dinitrate

A vasodilator used in the treatment of ANGINA PECTORIS. Its actions are similar to NITROGLYCERIN but with a slower onset of action.

Isosorbide Dinitrate Manufacturers

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

Isosorbide Dinitrate Suppliers

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

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

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

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

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

Isosorbide Dinitrate Manufacturers | Traders | Suppliers

Isosorbide Dinitrate Manufacturers, Traders, Suppliers 1
94

We have 3 companies offering Isosorbide Dinitrate

Get in contact with the supplier of your choice:

  1. Dipharma
  2. DOTTIKON EXCLUSIVE SYNTHESIS AG
  3. JP Laboratories
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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