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

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01 Hana Pharmaceutical Co., Ltd. (1)

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01 Hana Pharmaceutical Co., Ltd. (1)

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01 Flecainide acetate (1)

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01 South Korea (1)

URL Supplier Web Content
Hana Pharmaceutical Co., Ltd.
2021-03-23
20210323-211-J-896
Hana Pharmaceutical Co., ...
South Korea
133, Jaekongdan 3-gil, Hy...
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Looking for 54143-56-5 / Flecainide API manufacturers, exporters & distributors?

Flecainide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Flecainide

Synonyms

54143-56-5, Flecainide (acetate), Tambocor, R-818, Flecainide monoacetate, Flecainide acetate salt

Cas Number

54143-56-5

Unique Ingredient Identifier (UNII)

M8U465Q1WQ

About Flecainide

A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.

Flecainide Manufacturers

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

Flecainide Suppliers

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

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

Flecainide KDMF

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

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

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

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

Flecainide Manufacturers | Traders | Suppliers

Flecainide Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Flecainide

Get in contact with the supplier of your choice:

  1. Hana Pharm
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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