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