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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Acyclovir Orion
Dosage Form : Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 12-02-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Acyclovir Orion
Dosage Form : Tablet
Dosage Strength : 400mg
Packaging :
Approval Date : 12-02-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Acyclovir Orion
Dosage Form : Tablet
Dosage Strength : 800mg
Packaging :
Approval Date : 12-02-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 200 mg
Packaging : 25 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 400 mg
Packaging : 25 UNITS 400 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Aciclovir Pens
Dosage Form : Dispersible Tablet
Dosage Strength : 800MG
Packaging :
Approval Date : 01-09-1999
Application Number : 62741
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Aciclovir Pens
Dosage Form : Tablet
Dosage Strength : 800MG
Packaging :
Approval Date : 03-11-2022
Application Number : 88230
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Aciclovir Pensa Pharma
Dosage Form : Tablet
Dosage Strength : 800MG
Packaging :
Approval Date : 08-08-2018
Application Number : 82578
Regulatory Info : Authorized
Registration Country : Spain
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Aciclovir Pens
Dosage Form : Dispersible Tablet
Dosage Strength : 200MG
Packaging :
Approval Date : 01-09-1999
Application Number : 62740
Regulatory Info : Authorized
Registration Country : Spain
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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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ABOUT THIS PAGE
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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 Hascovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hascovir, including repackagers and relabelers. The FDA regulates Hascovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hascovir 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 Hascovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hascovir supplier is an individual or a company that provides Hascovir active pharmaceutical ingredient (API) or Hascovir finished formulations upon request. The Hascovir suppliers may include Hascovir API manufacturers, exporters, distributors and traders.
click here to find a list of Hascovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hascovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Hascovir active pharmaceutical ingredient (API) in detail. Different forms of Hascovir DMFs exist exist since differing nations have different regulations, such as Hascovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hascovir DMF submitted to regulatory agencies in the US is known as a USDMF. Hascovir USDMF includes data on Hascovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hascovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hascovir 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 Hascovir Drug Master File in Japan (Hascovir JDMF) empowers Hascovir 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 Hascovir JDMF during the approval evaluation for pharmaceutical products. At the time of Hascovir 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 Hascovir 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 Hascovir Drug Master File in Korea (Hascovir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hascovir. The MFDS reviews the Hascovir KDMF as part of the drug registration process and uses the information provided in the Hascovir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hascovir 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 Hascovir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hascovir suppliers with KDMF on PharmaCompass.
A Hascovir CEP of the European Pharmacopoeia monograph is often referred to as a Hascovir Certificate of Suitability (COS). The purpose of a Hascovir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hascovir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hascovir to their clients by showing that a Hascovir CEP has been issued for it. The manufacturer submits a Hascovir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hascovir CEP holder for the record. Additionally, the data presented in the Hascovir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hascovir DMF.
A Hascovir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hascovir 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 Hascovir suppliers with CEP (COS) on PharmaCompass.
A Hascovir written confirmation (Hascovir WC) is an official document issued by a regulatory agency to a Hascovir manufacturer, verifying that the manufacturing facility of a Hascovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hascovir APIs or Hascovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Hascovir WC (written confirmation) as part of the regulatory process.
click here to find a list of Hascovir 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 Hascovir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hascovir 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 Hascovir 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 Hascovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hascovir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hascovir suppliers with NDC on PharmaCompass.
Hascovir 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 Hascovir GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hascovir GMP manufacturer or Hascovir GMP API supplier for your needs.
A Hascovir CoA (Certificate of Analysis) is a formal document that attests to Hascovir's compliance with Hascovir specifications and serves as a tool for batch-level quality control.
Hascovir CoA mostly includes findings from lab analyses of a specific batch. For each Hascovir 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.
Hascovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Hascovir EP), Hascovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hascovir USP).
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