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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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 602 003, Tamil Nadu...
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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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SPI Pharma
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Sodium Phenylbutyrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sodium Phenylbutyrate manufacturer or Sodium Phenylbutyrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Phenylbutyrate manufacturer or Sodium Phenylbutyrate supplier.
PharmaCompass also assists you with knowing the Sodium Phenylbutyrate API Price utilized in the formulation of products. Sodium Phenylbutyrate API Price is not always fixed or binding as the Sodium Phenylbutyrate Price is obtained through a variety of data sources. The Sodium Phenylbutyrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CMK-304 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CMK-304, including repackagers and relabelers. The FDA regulates CMK-304 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CMK-304 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 CMK-304 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CMK-304 supplier is an individual or a company that provides CMK-304 active pharmaceutical ingredient (API) or CMK-304 finished formulations upon request. The CMK-304 suppliers may include CMK-304 API manufacturers, exporters, distributors and traders.
click here to find a list of CMK-304 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CMK-304 DMF (Drug Master File) is a document detailing the whole manufacturing process of CMK-304 active pharmaceutical ingredient (API) in detail. Different forms of CMK-304 DMFs exist exist since differing nations have different regulations, such as CMK-304 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CMK-304 DMF submitted to regulatory agencies in the US is known as a USDMF. CMK-304 USDMF includes data on CMK-304's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CMK-304 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CMK-304 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 CMK-304 Drug Master File in Japan (CMK-304 JDMF) empowers CMK-304 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 CMK-304 JDMF during the approval evaluation for pharmaceutical products. At the time of CMK-304 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 CMK-304 suppliers with JDMF on PharmaCompass.
A CMK-304 CEP of the European Pharmacopoeia monograph is often referred to as a CMK-304 Certificate of Suitability (COS). The purpose of a CMK-304 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CMK-304 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CMK-304 to their clients by showing that a CMK-304 CEP has been issued for it. The manufacturer submits a CMK-304 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CMK-304 CEP holder for the record. Additionally, the data presented in the CMK-304 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CMK-304 DMF.
A CMK-304 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CMK-304 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 CMK-304 suppliers with CEP (COS) on PharmaCompass.
A CMK-304 written confirmation (CMK-304 WC) is an official document issued by a regulatory agency to a CMK-304 manufacturer, verifying that the manufacturing facility of a CMK-304 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CMK-304 APIs or CMK-304 finished pharmaceutical products to another nation, regulatory agencies frequently require a CMK-304 WC (written confirmation) as part of the regulatory process.
click here to find a list of CMK-304 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 CMK-304 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CMK-304 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 CMK-304 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 CMK-304 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CMK-304 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CMK-304 suppliers with NDC on PharmaCompass.
CMK-304 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 CMK-304 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 CMK-304 GMP manufacturer or CMK-304 GMP API supplier for your needs.
A CMK-304 CoA (Certificate of Analysis) is a formal document that attests to CMK-304's compliance with CMK-304 specifications and serves as a tool for batch-level quality control.
CMK-304 CoA mostly includes findings from lab analyses of a specific batch. For each CMK-304 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.
CMK-304 may be tested according to a variety of international standards, such as European Pharmacopoeia (CMK-304 EP), CMK-304 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CMK-304 USP).
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