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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-28
Pay. Date : 2020-08-06
DMF Number : 33948
Submission : 2019-07-17
Status :
Type : II
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 : 2017-02-01
Pay. Date : 2016-12-26
DMF Number : 31250
Submission : 2017-01-02
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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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&...
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, ...
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...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
Trusted Partner for Innovative, Sustainable, and High-Quality API Development and Production.
About the Company : Alven Laboratories is a pharmaceutical company focused on the development, scale-up, and production of original and generic Active Pharmaceutical Ingredients (APIs). With expertise...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Nitisinone 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 Nitisinone manufacturer or Nitisinone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nitisinone manufacturer or Nitisinone supplier.
A Nitisinone (NTBC) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitisinone (NTBC), including repackagers and relabelers. The FDA regulates Nitisinone (NTBC) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitisinone (NTBC) 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 Nitisinone (NTBC) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nitisinone (NTBC) supplier is an individual or a company that provides Nitisinone (NTBC) active pharmaceutical ingredient (API) or Nitisinone (NTBC) finished formulations upon request. The Nitisinone (NTBC) suppliers may include Nitisinone (NTBC) API manufacturers, exporters, distributors and traders.
click here to find a list of Nitisinone (NTBC) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nitisinone (NTBC) DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitisinone (NTBC) active pharmaceutical ingredient (API) in detail. Different forms of Nitisinone (NTBC) DMFs exist exist since differing nations have different regulations, such as Nitisinone (NTBC) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitisinone (NTBC) DMF submitted to regulatory agencies in the US is known as a USDMF. Nitisinone (NTBC) USDMF includes data on Nitisinone (NTBC)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitisinone (NTBC) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitisinone (NTBC) suppliers with USDMF on PharmaCompass.
A Nitisinone (NTBC) written confirmation (Nitisinone (NTBC) WC) is an official document issued by a regulatory agency to a Nitisinone (NTBC) manufacturer, verifying that the manufacturing facility of a Nitisinone (NTBC) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nitisinone (NTBC) APIs or Nitisinone (NTBC) finished pharmaceutical products to another nation, regulatory agencies frequently require a Nitisinone (NTBC) WC (written confirmation) as part of the regulatory process.
click here to find a list of Nitisinone (NTBC) 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 Nitisinone (NTBC) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nitisinone (NTBC) 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 Nitisinone (NTBC) 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 Nitisinone (NTBC) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nitisinone (NTBC) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nitisinone (NTBC) suppliers with NDC on PharmaCompass.
Nitisinone (NTBC) 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 Nitisinone (NTBC) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nitisinone (NTBC) GMP manufacturer or Nitisinone (NTBC) GMP API supplier for your needs.
A Nitisinone (NTBC) CoA (Certificate of Analysis) is a formal document that attests to Nitisinone (NTBC)'s compliance with Nitisinone (NTBC) specifications and serves as a tool for batch-level quality control.
Nitisinone (NTBC) CoA mostly includes findings from lab analyses of a specific batch. For each Nitisinone (NTBC) 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.
Nitisinone (NTBC) may be tested according to a variety of international standards, such as European Pharmacopoeia (Nitisinone (NTBC) EP), Nitisinone (NTBC) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nitisinone (NTBC) USP).
