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API SUPPLIERS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Click Us!
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Together we can improve the quality of life
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
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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
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
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-21
Pay. Date : 2014-05-07
DMF Number : 12659
Submission : 1997-09-18
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 602 003, Tamil Nadu...
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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 : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Together we can improve the quality of life
About the Company : Shamrock Pharmachemi Pvt Ltd. is a globally recognized API leader with 26+ years in human and veterinary pharmaceuticals. Operating in 40+ countries, it owns two Gujarat facilities...
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
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ABOUT THIS PAGE
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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, 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.
A Trientine Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trientine Dihydrochloride, including repackagers and relabelers. The FDA regulates Trientine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trientine Dihydrochloride 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 Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Trientine Dihydrochloride supplier is an individual or a company that provides Trientine Dihydrochloride active pharmaceutical ingredient (API) or Trientine Dihydrochloride finished formulations upon request. The Trientine Dihydrochloride suppliers may include Trientine Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Trientine Dihydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Trientine Dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Trientine Dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Trientine Dihydrochloride DMFs exist exist since differing nations have different regulations, such as Trientine Dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trientine Dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Trientine Dihydrochloride USDMF includes data on Trientine Dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trientine Dihydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trientine Dihydrochloride 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 Dihydrochloride Drug Master File in Japan (Trientine Dihydrochloride JDMF) empowers Trientine Dihydrochloride 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 Dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Trientine Dihydrochloride 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 Dihydrochloride suppliers with JDMF on PharmaCompass.
A Trientine Dihydrochloride written confirmation (Trientine Dihydrochloride WC) is an official document issued by a regulatory agency to a Trientine Dihydrochloride manufacturer, verifying that the manufacturing facility of a Trientine Dihydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trientine Dihydrochloride APIs or Trientine Dihydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Trientine Dihydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Trientine Dihydrochloride 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 Dihydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trientine Dihydrochloride 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 Dihydrochloride 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 Dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trientine Dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trientine Dihydrochloride suppliers with NDC on PharmaCompass.
Trientine Dihydrochloride 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 Dihydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Trientine Dihydrochloride GMP manufacturer or Trientine Dihydrochloride GMP API supplier for your needs.
A Trientine Dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to Trientine Dihydrochloride's compliance with Trientine Dihydrochloride specifications and serves as a tool for batch-level quality control.
Trientine Dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Trientine Dihydrochloride 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 Dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Trientine Dihydrochloride EP), Trientine Dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trientine Dihydrochloride USP).
