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| Molecular Weight | 360.80 g/mol |
|---|---|
| Molecular Formula | C13H21ClN6O4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 8 |
| Exact Mass | 360.1312809 g/mol |
| Monoisotopic Mass | 360.1312809 g/mol |
| Topological Polar Surface Area | 147 A^2 |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 483 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Valacyclovir hydrochloride |
| Drug Label | VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochloride equivalent to 500mg or 1gram valacycl... |
| Active Ingredient | Valacyclovir hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base; eq 1gm base |
| Market Status | Prescription |
| Company | Wockhardt; Mylan Pharms; Ranbaxy; Apotex; Aurobindo Pharma; Sandoz; Cipla; Roxane; Watson Labs; Teva Pharms; Jubilant Generics; Dr Reddys Labs; Mylan |
| 2 of 2 | |
|---|---|
| Drug Name | Valacyclovir hydrochloride |
| Drug Label | VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochloride equivalent to 500mg or 1gram valacycl... |
| Active Ingredient | Valacyclovir hydrochloride |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base; eq 1gm base |
| Market Status | Prescription |
| Company | Wockhardt; Mylan Pharms; Ranbaxy; Apotex; Aurobindo Pharma; Sandoz; Cipla; Roxane; Watson Labs; Teva Pharms; Jubilant Generics; Dr Reddys Labs; Mylan |
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INTERMEDIATE SUPPLIERS
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DOSAGE - TABLET;ORAL - EQ 1GM BASE
USFDA APPLICATION NUMBER - 20487
DOSAGE - TABLET;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 20487
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PharmaCompass offers a list of Valacyclovir Hydrochloride 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 Valacyclovir Hydrochloride manufacturer or Valacyclovir Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valacyclovir Hydrochloride manufacturer or Valacyclovir Hydrochloride supplier.
PharmaCompass also assists you with knowing the Valacyclovir Hydrochloride API Price utilized in the formulation of products. Valacyclovir Hydrochloride API Price is not always fixed or binding as the Valacyclovir Hydrochloride Price is obtained through a variety of data sources. The Valacyclovir Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Valacyclovir HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valacyclovir HCl, including repackagers and relabelers. The FDA regulates Valacyclovir HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valacyclovir HCl 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 Valacyclovir HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valacyclovir HCl supplier is an individual or a company that provides Valacyclovir HCl active pharmaceutical ingredient (API) or Valacyclovir HCl finished formulations upon request. The Valacyclovir HCl suppliers may include Valacyclovir HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Valacyclovir HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valacyclovir HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Valacyclovir HCl active pharmaceutical ingredient (API) in detail. Different forms of Valacyclovir HCl DMFs exist exist since differing nations have different regulations, such as Valacyclovir HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valacyclovir HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Valacyclovir HCl USDMF includes data on Valacyclovir HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valacyclovir HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valacyclovir HCl 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 Valacyclovir HCl Drug Master File in Japan (Valacyclovir HCl JDMF) empowers Valacyclovir HCl 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 Valacyclovir HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Valacyclovir HCl 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 Valacyclovir HCl 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 Valacyclovir HCl Drug Master File in Korea (Valacyclovir HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valacyclovir HCl. The MFDS reviews the Valacyclovir HCl KDMF as part of the drug registration process and uses the information provided in the Valacyclovir HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valacyclovir HCl 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 Valacyclovir HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valacyclovir HCl suppliers with KDMF on PharmaCompass.
A Valacyclovir HCl CEP of the European Pharmacopoeia monograph is often referred to as a Valacyclovir HCl Certificate of Suitability (COS). The purpose of a Valacyclovir HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valacyclovir HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valacyclovir HCl to their clients by showing that a Valacyclovir HCl CEP has been issued for it. The manufacturer submits a Valacyclovir HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valacyclovir HCl CEP holder for the record. Additionally, the data presented in the Valacyclovir HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valacyclovir HCl DMF.
A Valacyclovir HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valacyclovir HCl 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 Valacyclovir HCl suppliers with CEP (COS) on PharmaCompass.
A Valacyclovir HCl written confirmation (Valacyclovir HCl WC) is an official document issued by a regulatory agency to a Valacyclovir HCl manufacturer, verifying that the manufacturing facility of a Valacyclovir HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valacyclovir HCl APIs or Valacyclovir HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Valacyclovir HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Valacyclovir HCl 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 Valacyclovir HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valacyclovir HCl 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 Valacyclovir HCl 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 Valacyclovir HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valacyclovir HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valacyclovir HCl suppliers with NDC on PharmaCompass.
Valacyclovir HCl 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 Valacyclovir HCl 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 Valacyclovir HCl GMP manufacturer or Valacyclovir HCl GMP API supplier for your needs.
A Valacyclovir HCl CoA (Certificate of Analysis) is a formal document that attests to Valacyclovir HCl's compliance with Valacyclovir HCl specifications and serves as a tool for batch-level quality control.
Valacyclovir HCl CoA mostly includes findings from lab analyses of a specific batch. For each Valacyclovir HCl 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.
Valacyclovir HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Valacyclovir HCl EP), Valacyclovir HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valacyclovir HCl USP).
