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List of Japan Drug Master File (JDMF) for Mexiletine Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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Looking for 5370-01-4 / Mexiletine API manufacturers, exporters & distributors?

Mexiletine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mexiletine

Synonyms

5370-01-4, Mexiletine hcl, Mexitil, Mexiletene hydrochloride, Mexiletine (hydrochloride), Katen

Cas Number

5370-01-4

Unique Ingredient Identifier (UNII)

606D60IS38

About Mexiletine

Antiarrhythmic agent pharmacologically similar to LIDOCAINE. It may have some anticonvulsant properties.

Mexiletine Manufacturers

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

Mexiletine Suppliers

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

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

Mexiletine 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 Mexiletine Drug Master File in Japan (Mexiletine JDMF) empowers Mexiletine 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 Mexiletine JDMF during the approval evaluation for pharmaceutical products. At the time of Mexiletine 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 Mexiletine suppliers with JDMF on PharmaCompass.

Mexiletine Manufacturers | Traders | Suppliers

Mexiletine Manufacturers, Traders, Suppliers 1
58

We have 3 companies offering Mexiletine

Get in contact with the supplier of your choice:

  1. Changzhou Yabang Pharmaceutical
  2. Changzhou Yabang Pharmaceutical Co ltd
  3. IWAKI SEIYAKU
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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