Synopsis
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Together we can improve the quality of life
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
Disintegrants & Superdisintegrants
Granulation
Chewable & Orodispersible Aids
Parenteral
Taste Masking
Thickeners and Stabilizers
Co-Processed Excipients
Solubilizers
Lubricants & Glidants
Empty Capsules
Coating Systems & Additives
Controlled & Modified Release
Film Formers & Plasticizers
Emulsifying Agents
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
16
PharmaCompass offers a list of Ganciclovir 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 Ganciclovir manufacturer or Ganciclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganciclovir manufacturer or Ganciclovir supplier.
A Cytovene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cytovene, including repackagers and relabelers. The FDA regulates Cytovene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cytovene 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 Cytovene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cytovene supplier is an individual or a company that provides Cytovene active pharmaceutical ingredient (API) or Cytovene finished formulations upon request. The Cytovene suppliers may include Cytovene API manufacturers, exporters, distributors and traders.
click here to find a list of Cytovene suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cytovene DMF (Drug Master File) is a document detailing the whole manufacturing process of Cytovene active pharmaceutical ingredient (API) in detail. Different forms of Cytovene DMFs exist exist since differing nations have different regulations, such as Cytovene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cytovene DMF submitted to regulatory agencies in the US is known as a USDMF. Cytovene USDMF includes data on Cytovene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cytovene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cytovene 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 Cytovene Drug Master File in Japan (Cytovene JDMF) empowers Cytovene 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 Cytovene JDMF during the approval evaluation for pharmaceutical products. At the time of Cytovene 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 Cytovene suppliers with JDMF on PharmaCompass.
A Cytovene CEP of the European Pharmacopoeia monograph is often referred to as a Cytovene Certificate of Suitability (COS). The purpose of a Cytovene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cytovene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cytovene to their clients by showing that a Cytovene CEP has been issued for it. The manufacturer submits a Cytovene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cytovene CEP holder for the record. Additionally, the data presented in the Cytovene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cytovene DMF.
A Cytovene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cytovene 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 Cytovene suppliers with CEP (COS) on PharmaCompass.
A Cytovene written confirmation (Cytovene WC) is an official document issued by a regulatory agency to a Cytovene manufacturer, verifying that the manufacturing facility of a Cytovene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cytovene APIs or Cytovene finished pharmaceutical products to another nation, regulatory agencies frequently require a Cytovene WC (written confirmation) as part of the regulatory process.
click here to find a list of Cytovene 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 Cytovene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cytovene 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 Cytovene 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 Cytovene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cytovene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cytovene suppliers with NDC on PharmaCompass.
Cytovene 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 Cytovene GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cytovene GMP manufacturer or Cytovene GMP API supplier for your needs.
A Cytovene CoA (Certificate of Analysis) is a formal document that attests to Cytovene's compliance with Cytovene specifications and serves as a tool for batch-level quality control.
Cytovene CoA mostly includes findings from lab analyses of a specific batch. For each Cytovene 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.
Cytovene may be tested according to a variety of international standards, such as European Pharmacopoeia (Cytovene EP), Cytovene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cytovene USP).
