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

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01 AMSA S. p. A. (1)

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01 Flecainide acetate (1)

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01 Italy (1)

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223MF10093
VIALE DEL GHISALLO, 20 20151 MILAN ...
2019-03-29
2011-06-29
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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 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 Flecainide Drug Master File in Japan (Flecainide JDMF) empowers Flecainide 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 Flecainide JDMF during the approval evaluation for pharmaceutical products. At the time of Flecainide 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 Flecainide suppliers with JDMF 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. Amsa Spa
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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