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

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222MF10036
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2010-01-28
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2012-07-09
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Looking for 90098-04-7 / Rebamipide API manufacturers, exporters & distributors?

Rebamipide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rebamipide

Synonyms

90098-04-7, Proamipide, Mucosta, 111911-87-6, Opc-12759, Rebamipide hydrate

Cas Number

90098-04-7

Unique Ingredient Identifier (UNII)

LR583V32ZR

About Rebamipide

Rebamipide is a quinolinone derivative with anti-ulcer and anti-inflammatory activities. Rebamipide induces cyclooxygenase 2 (COX2) synthesis which results in an increase in endogenous prostaglandin synthesis in the gastric mucosa. This agent also inhibits H. pylori-induced production of tumor necrosis factor (TNF) alpha and subsequent inflammation of the gastric mucosa. In addition, rebamipide scavenges oxygen-derived free radicals that potentially cause mucosal injury, and stimulates prostaglandin EP4 receptor gene expression followed by mucous secretion, thereby enhancing the gastric mucosal defense.

Rebamipide Manufacturers

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

Rebamipide Suppliers

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

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

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

Rebamipide Manufacturers | Traders | Suppliers

Rebamipide Manufacturers, Traders, Suppliers 1
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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