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PharmaCompass offers a list of Tiagabine Hydrochloride 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 Tiagabine Hydrochloride manufacturer or Tiagabine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tiagabine Hydrochloride manufacturer or Tiagabine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Tiagabine Hydrochloride API Price utilized in the formulation of products. Tiagabine Hydrochloride API Price is not always fixed or binding as the Tiagabine Hydrochloride Price is obtained through a variety of data sources. The Tiagabine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tiagabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiagabine, including repackagers and relabelers. The FDA regulates Tiagabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiagabine 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 Tiagabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tiagabine supplier is an individual or a company that provides Tiagabine active pharmaceutical ingredient (API) or Tiagabine finished formulations upon request. The Tiagabine suppliers may include Tiagabine API manufacturers, exporters, distributors and traders.
click here to find a list of Tiagabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tiagabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tiagabine active pharmaceutical ingredient (API) in detail. Different forms of Tiagabine DMFs exist exist since differing nations have different regulations, such as Tiagabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tiagabine DMF submitted to regulatory agencies in the US is known as a USDMF. Tiagabine USDMF includes data on Tiagabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tiagabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tiagabine suppliers with USDMF on PharmaCompass.
A Tiagabine written confirmation (Tiagabine WC) is an official document issued by a regulatory agency to a Tiagabine manufacturer, verifying that the manufacturing facility of a Tiagabine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tiagabine APIs or Tiagabine finished pharmaceutical products to another nation, regulatory agencies frequently require a Tiagabine WC (written confirmation) as part of the regulatory process.
click here to find a list of Tiagabine 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 Tiagabine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tiagabine 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 Tiagabine 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 Tiagabine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tiagabine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tiagabine suppliers with NDC on PharmaCompass.
Tiagabine 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 Tiagabine 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 Tiagabine GMP manufacturer or Tiagabine GMP API supplier for your needs.
A Tiagabine CoA (Certificate of Analysis) is a formal document that attests to Tiagabine's compliance with Tiagabine specifications and serves as a tool for batch-level quality control.
Tiagabine CoA mostly includes findings from lab analyses of a specific batch. For each Tiagabine 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.
Tiagabine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tiagabine EP), Tiagabine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tiagabine USP).