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

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01 Shiratori Pharmaceutical Co., Ltd.@Nipro Pharma Corporation (1)

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01 Kolon Pharmaceutical Co., Ltd. (1)

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01 Emedastine fumarate sustained release granule (1)

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01 Japan (1)

URL Supplier Web Content
Kolon Pharmaceutical Co., Ltd.
2022-02-08
20220208-209-J-1230
Shiratori Pharmaceutical ...
Japan
54 Shinminato, Mihama-ku,...
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Looking for 87233-62-3 / Emedastine Fumarate API manufacturers, exporters & distributors?

Emedastine Fumarate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Emedastine Fumarate

Synonyms

87233-62-3, Rapimine, Kb-2413, Al-3432a, Daren, 1-(2-ethoxyethyl)-2-(4-methyl-1-homopiperazinyl)benzimidazole difumarate

Cas Number

87233-62-3

Unique Ingredient Identifier (UNII)

42MB94QOSM

About Emedastine Fumarate

Emedastine Difumarate is the difumarate salt form of emedastine, a second generation, selective histamine H1 receptor antagonist with anti-allergic activity. Emedastine reversibly and competitively blocks histamine by binding to H1 receptors, thus blocking its downstream activity. As a result, this agent interferes with mediator release from mast cells either by inhibiting calcium ion influx across mast cell/basophil plasma membrane or by inhibiting intracellular calcium ion release within the cells. In addition, emedastine may also inhibit the late-phase allergic reaction mediated through leukotrienes or prostaglandins, or by producing an anti-platelet activating factor effect. Upon ocular administration, emedastine causes a dose-dependent inhibition of histamine-stimulated vascular permeability in the conjunctiva. Emedastine does not affect adrenergic, dopamine, or serotonin receptors.

Emedastine Fumarate Manufacturers

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

Emedastine Fumarate Suppliers

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

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

Emedastine Fumarate KDMF

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

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

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

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

Emedastine Fumarate Manufacturers | Traders | Suppliers

Emedastine Fumarate Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Emedastine Fumarate

Get in contact with the supplier of your choice:

  1. Shiratori Pharmaceutical
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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