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API SUPPLIERS
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USDMF
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-20
Pay. Date : 2023-03-15
DMF Number : 38120
Submission : 2023-03-09
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38371
Submission : 2023-05-31
Status :
Type : II
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Trientine Tetrahydrochloride IH
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111 SIDCO Industrial Estate, Kakkalur Thiruvallur-602003 Tamil Nadu, In...
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Trientine Tetrahydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trientine Tetrahydrochloride, including repackagers and relabelers. The FDA regulates Trientine Tetrahydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trientine Tetrahydrochloride 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 Trientine Tetrahydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trientine Tetrahydrochloride supplier is an individual or a company that provides Trientine Tetrahydrochloride active pharmaceutical ingredient (API) or Trientine Tetrahydrochloride finished formulations upon request. The Trientine Tetrahydrochloride suppliers may include Trientine Tetrahydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Trientine Tetrahydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trientine Tetrahydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Trientine Tetrahydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Trientine Tetrahydrochloride DMFs exist exist since differing nations have different regulations, such as Trientine Tetrahydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trientine Tetrahydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Trientine Tetrahydrochloride USDMF includes data on Trientine Tetrahydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trientine Tetrahydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trientine Tetrahydrochloride suppliers with USDMF on PharmaCompass.
A Trientine Tetrahydrochloride written confirmation (Trientine Tetrahydrochloride WC) is an official document issued by a regulatory agency to a Trientine Tetrahydrochloride manufacturer, verifying that the manufacturing facility of a Trientine Tetrahydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trientine Tetrahydrochloride APIs or Trientine Tetrahydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Trientine Tetrahydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Trientine Tetrahydrochloride 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 Trientine Tetrahydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trientine Tetrahydrochloride 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 Trientine Tetrahydrochloride 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 Trientine Tetrahydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trientine Tetrahydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trientine Tetrahydrochloride suppliers with NDC on PharmaCompass.
Trientine Tetrahydrochloride 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 Trientine Tetrahydrochloride 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 Trientine Tetrahydrochloride GMP manufacturer or Trientine Tetrahydrochloride GMP API supplier for your needs.
A Trientine Tetrahydrochloride CoA (Certificate of Analysis) is a formal document that attests to Trientine Tetrahydrochloride's compliance with Trientine Tetrahydrochloride specifications and serves as a tool for batch-level quality control.
Trientine Tetrahydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Trientine Tetrahydrochloride 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.
Trientine Tetrahydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Trientine Tetrahydrochloride EP), Trientine Tetrahydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trientine Tetrahydrochloride USP).
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