Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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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**Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federa...DOSAGE - SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Regist...DOSAGE - TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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EUROAPI
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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
Direct Compression
Granulation
Topical
Solubilizers
Film Formers & Plasticizers
Coating Systems & Additives
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
WEEKLY NEWS RECAP #Phispers
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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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
64
PharmaCompass offers a list of Acyclovir 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 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.
A Sitavig manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitavig, including repackagers and relabelers. The FDA regulates Sitavig manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitavig 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 Sitavig manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sitavig supplier is an individual or a company that provides Sitavig active pharmaceutical ingredient (API) or Sitavig finished formulations upon request. The Sitavig suppliers may include Sitavig API manufacturers, exporters, distributors and traders.
click here to find a list of Sitavig suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sitavig DMF (Drug Master File) is a document detailing the whole manufacturing process of Sitavig active pharmaceutical ingredient (API) in detail. Different forms of Sitavig DMFs exist exist since differing nations have different regulations, such as Sitavig USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sitavig DMF submitted to regulatory agencies in the US is known as a USDMF. Sitavig USDMF includes data on Sitavig's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sitavig USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sitavig 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 Sitavig Drug Master File in Japan (Sitavig JDMF) empowers Sitavig 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 Sitavig JDMF during the approval evaluation for pharmaceutical products. At the time of Sitavig 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 Sitavig 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 Sitavig Drug Master File in Korea (Sitavig KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sitavig. The MFDS reviews the Sitavig KDMF as part of the drug registration process and uses the information provided in the Sitavig KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sitavig 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 Sitavig API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sitavig suppliers with KDMF on PharmaCompass.
A Sitavig CEP of the European Pharmacopoeia monograph is often referred to as a Sitavig Certificate of Suitability (COS). The purpose of a Sitavig CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sitavig EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sitavig to their clients by showing that a Sitavig CEP has been issued for it. The manufacturer submits a Sitavig CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sitavig CEP holder for the record. Additionally, the data presented in the Sitavig CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sitavig DMF.
A Sitavig CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sitavig 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 Sitavig suppliers with CEP (COS) on PharmaCompass.
A Sitavig written confirmation (Sitavig WC) is an official document issued by a regulatory agency to a Sitavig manufacturer, verifying that the manufacturing facility of a Sitavig active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sitavig APIs or Sitavig finished pharmaceutical products to another nation, regulatory agencies frequently require a Sitavig WC (written confirmation) as part of the regulatory process.
click here to find a list of Sitavig 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 Sitavig as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sitavig 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 Sitavig 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 Sitavig and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sitavig NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sitavig suppliers with NDC on PharmaCompass.
Sitavig 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 Sitavig GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sitavig GMP manufacturer or Sitavig GMP API supplier for your needs.
A Sitavig CoA (Certificate of Analysis) is a formal document that attests to Sitavig's compliance with Sitavig specifications and serves as a tool for batch-level quality control.
Sitavig CoA mostly includes findings from lab analyses of a specific batch. For each Sitavig 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.
Sitavig may be tested according to a variety of international standards, such as European Pharmacopoeia (Sitavig EP), Sitavig JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sitavig USP).
