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API SUPPLIERS
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INTERMEDIATES SUPPLIERS
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DOSAGE - INJECTABLE;INJECTION - 100MG/ML
USFDA APPLICATION NUMBER - 17530
DOSAGE - CAPSULE;ORAL - 300MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17531
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Trimethobenzamide HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimethobenzamide HCl, including repackagers and relabelers. The FDA regulates Trimethobenzamide HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimethobenzamide HCl 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 Trimethobenzamide HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimethobenzamide HCl supplier is an individual or a company that provides Trimethobenzamide HCl active pharmaceutical ingredient (API) or Trimethobenzamide HCl finished formulations upon request. The Trimethobenzamide HCl suppliers may include Trimethobenzamide HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Trimethobenzamide HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimethobenzamide HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimethobenzamide HCl active pharmaceutical ingredient (API) in detail. Different forms of Trimethobenzamide HCl DMFs exist exist since differing nations have different regulations, such as Trimethobenzamide HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimethobenzamide HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Trimethobenzamide HCl USDMF includes data on Trimethobenzamide HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimethobenzamide HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimethobenzamide HCl suppliers with USDMF on PharmaCompass.
A Trimethobenzamide HCl written confirmation (Trimethobenzamide HCl WC) is an official document issued by a regulatory agency to a Trimethobenzamide HCl manufacturer, verifying that the manufacturing facility of a Trimethobenzamide HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trimethobenzamide HCl APIs or Trimethobenzamide HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Trimethobenzamide HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Trimethobenzamide HCl suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Trimethobenzamide HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trimethobenzamide HCl API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Trimethobenzamide HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Trimethobenzamide HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trimethobenzamide HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trimethobenzamide HCl suppliers with NDC on PharmaCompass.
Trimethobenzamide HCl 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 Trimethobenzamide HCl 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 Trimethobenzamide HCl GMP manufacturer or Trimethobenzamide HCl GMP API supplier for your needs.
A Trimethobenzamide HCl CoA (Certificate of Analysis) is a formal document that attests to Trimethobenzamide HCl's compliance with Trimethobenzamide HCl specifications and serves as a tool for batch-level quality control.
Trimethobenzamide HCl CoA mostly includes findings from lab analyses of a specific batch. For each Trimethobenzamide HCl 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.
Trimethobenzamide HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Trimethobenzamide HCl EP), Trimethobenzamide HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trimethobenzamide HCl USP).
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