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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.
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NDC
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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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 : 2016-12-23
Pay. Date : 2016-09-13
DMF Number : 30878
Submission : 2016-11-08
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-15
Pay. Date : 2015-09-21
DMF Number : 29019
Submission : 2015-09-25
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-01
Pay. Date : 2015-09-15
DMF Number : 29527
Submission : 2015-09-03
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.
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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Trientine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trientine Hydrochloride, including repackagers and relabelers. The FDA regulates Trientine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trientine 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 Trientine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trientine Hydrochloride supplier is an individual or a company that provides Trientine Hydrochloride active pharmaceutical ingredient (API) or Trientine Hydrochloride finished formulations upon request. The Trientine Hydrochloride suppliers may include Trientine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Trientine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trientine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Trientine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Trientine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Trientine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trientine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Trientine Hydrochloride USDMF includes data on Trientine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trientine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trientine Hydrochloride 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 Trientine Hydrochloride Drug Master File in Japan (Trientine Hydrochloride JDMF) empowers Trientine Hydrochloride 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 Trientine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Trientine Hydrochloride 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 Trientine Hydrochloride suppliers with JDMF on PharmaCompass.
A Trientine Hydrochloride written confirmation (Trientine Hydrochloride WC) is an official document issued by a regulatory agency to a Trientine Hydrochloride manufacturer, verifying that the manufacturing facility of a Trientine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trientine Hydrochloride APIs or Trientine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Trientine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Trientine 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 Trientine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trientine 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 Trientine 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 Trientine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trientine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trientine Hydrochloride suppliers with NDC on PharmaCompass.
Trientine 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 Trientine 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 Trientine Hydrochloride GMP manufacturer or Trientine Hydrochloride GMP API supplier for your needs.
A Trientine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Trientine Hydrochloride's compliance with Trientine Hydrochloride specifications and serves as a tool for batch-level quality control.
Trientine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Trientine 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.
Trientine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Trientine Hydrochloride EP), Trientine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trientine Hydrochloride USP).
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