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