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KDMF
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South Africa
DRUG PRODUCT COMPOSITIONS0
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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 : 2023-11-15
Pay. Date : 2023-09-27
DMF Number : 38890
Submission : 2023-09-29
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-12-08
DMF Number : 9716
Submission : 1992-06-08
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22048
Submission : 2008-10-01
Status :
Type : II
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Registration Number : 223MF10149
Registrant's Address : Raiffeisenstrasse 4, D-77933 Lahr Germany
Initial Date of Registration : 2011-10-14
Latest Date of Registration : 2023-11-01
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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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Drugs in Development
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DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 20572
DOSAGE - POWDER;ORAL - 3GM/TEASPOONFUL
USFDA APPLICATION NUMBER - 20573
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sodium Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Phenylbutyrate, including repackagers and relabelers. The FDA regulates Sodium Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Phenylbutyrate 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 Sodium Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Phenylbutyrate supplier is an individual or a company that provides Sodium Phenylbutyrate active pharmaceutical ingredient (API) or Sodium Phenylbutyrate finished formulations upon request. The Sodium Phenylbutyrate suppliers may include Sodium Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Phenylbutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Phenylbutyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Phenylbutyrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Phenylbutyrate DMFs exist exist since differing nations have different regulations, such as Sodium Phenylbutyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Phenylbutyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Phenylbutyrate USDMF includes data on Sodium Phenylbutyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Phenylbutyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Phenylbutyrate 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 Sodium Phenylbutyrate Drug Master File in Japan (Sodium Phenylbutyrate JDMF) empowers Sodium Phenylbutyrate 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 Sodium Phenylbutyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Phenylbutyrate 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 Sodium Phenylbutyrate suppliers with JDMF on PharmaCompass.
A Sodium Phenylbutyrate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Phenylbutyrate Certificate of Suitability (COS). The purpose of a Sodium Phenylbutyrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Phenylbutyrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Phenylbutyrate to their clients by showing that a Sodium Phenylbutyrate CEP has been issued for it. The manufacturer submits a Sodium Phenylbutyrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Phenylbutyrate CEP holder for the record. Additionally, the data presented in the Sodium Phenylbutyrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Phenylbutyrate DMF.
A Sodium Phenylbutyrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Phenylbutyrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Sodium Phenylbutyrate suppliers with CEP (COS) on PharmaCompass.
A Sodium Phenylbutyrate written confirmation (Sodium Phenylbutyrate WC) is an official document issued by a regulatory agency to a Sodium Phenylbutyrate manufacturer, verifying that the manufacturing facility of a Sodium Phenylbutyrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Phenylbutyrate APIs or Sodium Phenylbutyrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Phenylbutyrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Phenylbutyrate 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 Sodium Phenylbutyrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Phenylbutyrate 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 Sodium Phenylbutyrate 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 Sodium Phenylbutyrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Phenylbutyrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Phenylbutyrate suppliers with NDC on PharmaCompass.
Sodium Phenylbutyrate 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 Sodium Phenylbutyrate 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 Sodium Phenylbutyrate GMP manufacturer or Sodium Phenylbutyrate GMP API supplier for your needs.
A Sodium Phenylbutyrate CoA (Certificate of Analysis) is a formal document that attests to Sodium Phenylbutyrate's compliance with Sodium Phenylbutyrate specifications and serves as a tool for batch-level quality control.
Sodium Phenylbutyrate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Phenylbutyrate 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.
Sodium Phenylbutyrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Phenylbutyrate EP), Sodium Phenylbutyrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Phenylbutyrate USP).
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