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KDMF
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VMF
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EDQM
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USP
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JP
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FDF Dossiers
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FDA Orange Book
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Cifenline 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 Cifenline manufacturer or Cifenline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cifenline manufacturer or Cifenline supplier.
PharmaCompass also assists you with knowing the Cifenline API Price utilized in the formulation of products. Cifenline API Price is not always fixed or binding as the Cifenline Price is obtained through a variety of data sources. The Cifenline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CIBENZOLINE SUCCINATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CIBENZOLINE SUCCINATE, including repackagers and relabelers. The FDA regulates CIBENZOLINE SUCCINATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CIBENZOLINE SUCCINATE supplier is an individual or a company that provides CIBENZOLINE SUCCINATE active pharmaceutical ingredient (API) or CIBENZOLINE SUCCINATE finished formulations upon request. The CIBENZOLINE SUCCINATE suppliers may include CIBENZOLINE SUCCINATE API manufacturers, exporters, distributors and traders.
click here to find a list of CIBENZOLINE SUCCINATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CIBENZOLINE SUCCINATE DMF (Drug Master File) is a document detailing the whole manufacturing process of CIBENZOLINE SUCCINATE active pharmaceutical ingredient (API) in detail. Different forms of CIBENZOLINE SUCCINATE DMFs exist exist since differing nations have different regulations, such as CIBENZOLINE SUCCINATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CIBENZOLINE SUCCINATE DMF submitted to regulatory agencies in the US is known as a USDMF. CIBENZOLINE SUCCINATE USDMF includes data on CIBENZOLINE SUCCINATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CIBENZOLINE SUCCINATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE Drug Master File in Japan (CIBENZOLINE SUCCINATE JDMF) empowers CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE JDMF during the approval evaluation for pharmaceutical products. At the time of CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE suppliers with JDMF 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 CIBENZOLINE SUCCINATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CIBENZOLINE SUCCINATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CIBENZOLINE SUCCINATE suppliers with NDC on PharmaCompass.
CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE 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 CIBENZOLINE SUCCINATE GMP manufacturer or CIBENZOLINE SUCCINATE GMP API supplier for your needs.
A CIBENZOLINE SUCCINATE CoA (Certificate of Analysis) is a formal document that attests to CIBENZOLINE SUCCINATE's compliance with CIBENZOLINE SUCCINATE specifications and serves as a tool for batch-level quality control.
CIBENZOLINE SUCCINATE CoA mostly includes findings from lab analyses of a specific batch. For each CIBENZOLINE SUCCINATE 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.
CIBENZOLINE SUCCINATE may be tested according to a variety of international standards, such as European Pharmacopoeia (CIBENZOLINE SUCCINATE EP), CIBENZOLINE SUCCINATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CIBENZOLINE SUCCINATE USP).
