Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - 200MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18828
DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federa...DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19909
DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - TABLET;ORAL - 800MG **Federal Regist...DOSAGE - TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Cerata Pharmaceuticals LLP
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]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
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]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
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]Esteem Industries
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]Kima Chemical
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]Nanjing Bold Chemical
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]Nomisma Healthcare
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]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Granulation
Direct Compression
Topical
Solubilizers
Coating Systems & Additives
Film Formers & Plasticizers
Lubricants & Glidants
Controlled & Modified Release
Chewable & Orodispersible Aids
Parenteral
Taste Masking
Co-Processed Excipients
Emulsifying Agents
Empty Capsules
Rheology Modifiers
Surfactant & Foaming Agents
API Stability Enhancers
Soft Gelatin
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
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
17
PharmaCompass offers a list of Acyclovir 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 Acyclovir manufacturer or Acyclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acyclovir manufacturer or Acyclovir supplier.
PharmaCompass also assists you with knowing the Acyclovir API Price utilized in the formulation of products. Acyclovir API Price is not always fixed or binding as the Acyclovir Price is obtained through a variety of data sources. The Acyclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CS-1353 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CS-1353, including repackagers and relabelers. The FDA regulates CS-1353 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CS-1353 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 CS-1353 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CS-1353 supplier is an individual or a company that provides CS-1353 active pharmaceutical ingredient (API) or CS-1353 finished formulations upon request. The CS-1353 suppliers may include CS-1353 API manufacturers, exporters, distributors and traders.
click here to find a list of CS-1353 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CS-1353 DMF (Drug Master File) is a document detailing the whole manufacturing process of CS-1353 active pharmaceutical ingredient (API) in detail. Different forms of CS-1353 DMFs exist exist since differing nations have different regulations, such as CS-1353 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CS-1353 DMF submitted to regulatory agencies in the US is known as a USDMF. CS-1353 USDMF includes data on CS-1353's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CS-1353 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CS-1353 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 CS-1353 Drug Master File in Japan (CS-1353 JDMF) empowers CS-1353 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 CS-1353 JDMF during the approval evaluation for pharmaceutical products. At the time of CS-1353 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 CS-1353 suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CS-1353 Drug Master File in Korea (CS-1353 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CS-1353. The MFDS reviews the CS-1353 KDMF as part of the drug registration process and uses the information provided in the CS-1353 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CS-1353 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their CS-1353 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CS-1353 suppliers with KDMF on PharmaCompass.
A CS-1353 CEP of the European Pharmacopoeia monograph is often referred to as a CS-1353 Certificate of Suitability (COS). The purpose of a CS-1353 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CS-1353 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CS-1353 to their clients by showing that a CS-1353 CEP has been issued for it. The manufacturer submits a CS-1353 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CS-1353 CEP holder for the record. Additionally, the data presented in the CS-1353 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CS-1353 DMF.
A CS-1353 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CS-1353 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 CS-1353 suppliers with CEP (COS) on PharmaCompass.
A CS-1353 written confirmation (CS-1353 WC) is an official document issued by a regulatory agency to a CS-1353 manufacturer, verifying that the manufacturing facility of a CS-1353 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CS-1353 APIs or CS-1353 finished pharmaceutical products to another nation, regulatory agencies frequently require a CS-1353 WC (written confirmation) as part of the regulatory process.
click here to find a list of CS-1353 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 CS-1353 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CS-1353 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 CS-1353 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 CS-1353 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CS-1353 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CS-1353 suppliers with NDC on PharmaCompass.
CS-1353 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 CS-1353 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 CS-1353 GMP manufacturer or CS-1353 GMP API supplier for your needs.
A CS-1353 CoA (Certificate of Analysis) is a formal document that attests to CS-1353's compliance with CS-1353 specifications and serves as a tool for batch-level quality control.
CS-1353 CoA mostly includes findings from lab analyses of a specific batch. For each CS-1353 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.
CS-1353 may be tested according to a variety of international standards, such as European Pharmacopoeia (CS-1353 EP), CS-1353 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CS-1353 USP).
