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Looking for 22345-47-7 / Tofisopam API manufacturers, exporters & distributors?

Tofisopam manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tofisopam

Synonyms

22345-47-7, Grandaxin, 1-(3,4-dimethoxyphenyl)-5-ethyl-7,8-dimethoxy-4-methyl-5h-2,3-benzodiazepine, Emandaxin, Egyt 341, Tofisopamum

Cas Number

22345-47-7

Unique Ingredient Identifier (UNII)

UZC80HAU42

About Tofisopam

Tofisopam (marketed under brand names Emandaxin and Grandaxin) is a 2,3-benzodiazepine drug which is a benzodiazepine derivative. In contrast to classical 1,4-benzodiazepines, the compound does not bind to the benzodiazepine binding site of the gamma-aminobutyric acid receptor and its psychopharmacological profile differs from such compounds. Although Tofisopam is not approved for sale in North America, it is approved for use in various countries worldwide, including parts of Europe. The D-enantiomer ([dextofisopam]) is currently in phase II trials in the U.S. for the treatment of irritable bowel syndrome.

Tofisopam Manufacturers

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

Tofisopam Suppliers

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

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

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

Tofisopam KDMF

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

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

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

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

Tofisopam WC

A Tofisopam written confirmation (Tofisopam WC) is an official document issued by a regulatory agency to a Tofisopam manufacturer, verifying that the manufacturing facility of a Tofisopam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tofisopam APIs or Tofisopam finished pharmaceutical products to another nation, regulatory agencies frequently require a Tofisopam WC (written confirmation) as part of the regulatory process.

click here to find a list of Tofisopam suppliers with Written Confirmation (WC) on PharmaCompass.

Tofisopam GMP

Tofisopam Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Tofisopam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Tofisopam GMP manufacturer or Tofisopam GMP API supplier for your needs.

Tofisopam CoA

A Tofisopam CoA (Certificate of Analysis) is a formal document that attests to Tofisopam's compliance with Tofisopam specifications and serves as a tool for batch-level quality control.

Tofisopam CoA mostly includes findings from lab analyses of a specific batch. For each Tofisopam CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Tofisopam may be tested according to a variety of international standards, such as European Pharmacopoeia (Tofisopam EP), Tofisopam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tofisopam USP).

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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