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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Date of Issue : 2022-02-22
Valid Till : 2026-12-31
Written Confirmation Number : TFDA-0002291
Address of the Firm : No. 168, Kai Yuan Rd, Hsin-Ying, Tainan City 73055, Taiwan
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Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
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PharmaCompass offers a list of Tolperisone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tolperisone manufacturer or Tolperisone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tolperisone manufacturer or Tolperisone supplier.
A Tolperisone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolperisone, including repackagers and relabelers. The FDA regulates Tolperisone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolperisone 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 Tolperisone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tolperisone supplier is an individual or a company that provides Tolperisone active pharmaceutical ingredient (API) or Tolperisone finished formulations upon request. The Tolperisone suppliers may include Tolperisone API manufacturers, exporters, distributors and traders.
click here to find a list of Tolperisone suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tolperisone DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolperisone active pharmaceutical ingredient (API) in detail. Different forms of Tolperisone DMFs exist exist since differing nations have different regulations, such as Tolperisone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolperisone DMF submitted to regulatory agencies in the US is known as a USDMF. Tolperisone USDMF includes data on Tolperisone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolperisone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolperisone suppliers with USDMF on PharmaCompass.
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 Tolperisone Drug Master File in Japan (Tolperisone JDMF) empowers Tolperisone 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 Tolperisone JDMF during the approval evaluation for pharmaceutical products. At the time of Tolperisone 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 Tolperisone suppliers with JDMF on PharmaCompass.
A Tolperisone written confirmation (Tolperisone WC) is an official document issued by a regulatory agency to a Tolperisone manufacturer, verifying that the manufacturing facility of a Tolperisone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tolperisone APIs or Tolperisone finished pharmaceutical products to another nation, regulatory agencies frequently require a Tolperisone WC (written confirmation) as part of the regulatory process.
click here to find a list of Tolperisone suppliers with Written Confirmation (WC) on PharmaCompass.
Tolperisone 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 Tolperisone GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tolperisone GMP manufacturer or Tolperisone GMP API supplier for your needs.
A Tolperisone CoA (Certificate of Analysis) is a formal document that attests to Tolperisone's compliance with Tolperisone specifications and serves as a tool for batch-level quality control.
Tolperisone CoA mostly includes findings from lab analyses of a specific batch. For each Tolperisone 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.
Tolperisone may be tested according to a variety of international standards, such as European Pharmacopoeia (Tolperisone EP), Tolperisone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tolperisone USP).
