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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 12MG
USFDA APPLICATION NUMBER - 20646
DOSAGE - TABLET;ORAL - 16MG
USFDA APPLICATION NUMBER - 20646
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 20646
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 20646
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tiagabine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiagabine Hydrochloride, including repackagers and relabelers. The FDA regulates Tiagabine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiagabine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tiagabine Hydrochloride supplier is an individual or a company that provides Tiagabine Hydrochloride active pharmaceutical ingredient (API) or Tiagabine Hydrochloride finished formulations upon request. The Tiagabine Hydrochloride suppliers may include Tiagabine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Tiagabine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tiagabine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Tiagabine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Tiagabine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Tiagabine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tiagabine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Tiagabine Hydrochloride USDMF includes data on Tiagabine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tiagabine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tiagabine Hydrochloride suppliers with USDMF on PharmaCompass.
A Tiagabine Hydrochloride written confirmation (Tiagabine Hydrochloride WC) is an official document issued by a regulatory agency to a Tiagabine Hydrochloride manufacturer, verifying that the manufacturing facility of a Tiagabine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tiagabine Hydrochloride APIs or Tiagabine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Tiagabine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Tiagabine Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tiagabine Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tiagabine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tiagabine Hydrochloride suppliers with NDC on PharmaCompass.
Tiagabine Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Tiagabine Hydrochloride GMP API supplier for your needs.
A Tiagabine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Tiagabine Hydrochloride's compliance with Tiagabine Hydrochloride specifications and serves as a tool for batch-level quality control.
Tiagabine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Tiagabine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Tiagabine Hydrochloride EP), Tiagabine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tiagabine Hydrochloride USP).
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