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DRUG PRODUCT COMPOSITIONS0
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| Molecular Weight | 225.20 g/mol |
|---|---|
| Molecular Formula | C8H11N5O3 |
| XLogP3 | -1.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 225.08618923 g/mol |
| Monoisotopic Mass | 225.08618923 g/mol |
| Topological Polar Surface Area | 115 A^2 |
| Heavy Atom Count | 16 |
| Formal Charge | 0 |
| Complexity | 308 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Acyclovir |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Capsule; Suspension |
| Route | Topical; Oral |
| Strength | 5%; 200mg/5ml; 200mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Amneal Pharms; Mylan Pharms; Ranbaxy; Hetero Labs Ltd V; Hi Tech Pharma; Actavis Mid Atlantic; Teva; Cadila Pharms; Apotex; Zydus Pharms Usa; Carlsbad; Mylan; Stason; Dava Pharms |
| 2 of 8 | |
|---|---|
| Drug Name | Acyclovir sodium |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 100... |
| Active Ingredient | Acyclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Bedford; Fresenius Kabi Usa; Aurobindo Pharma |
| 3 of 8 | |
|---|---|
| Drug Name | Sitavig |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see ClinicalPharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. Th... |
| Active Ingredient | Acyclovir |
| Dosage Form | Tablet |
| Route | Buccal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Innocutis Holdings |
| 4 of 8 | |
|---|---|
| Drug Name | Zovirax |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Cream; Capsule; Suspension |
| Route | Oral; Topical |
| Strength | 200mg/5ml; 200mg; 800mg; 400mg; 5% |
| Market Status | Prescription |
| Company | Delcor Asset; Valeant Bermuda |
| 5 of 8 | |
|---|---|
| Drug Name | Acyclovir |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Capsule; Suspension |
| Route | Topical; Oral |
| Strength | 5%; 200mg/5ml; 200mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Amneal Pharms; Mylan Pharms; Ranbaxy; Hetero Labs Ltd V; Hi Tech Pharma; Actavis Mid Atlantic; Teva; Cadila Pharms; Apotex; Zydus Pharms Usa; Carlsbad; Mylan; Stason; Dava Pharms |
| 6 of 8 | |
|---|---|
| Drug Name | Acyclovir sodium |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 100... |
| Active Ingredient | Acyclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Bedford; Fresenius Kabi Usa; Aurobindo Pharma |
| 7 of 8 | |
|---|---|
| Drug Name | Sitavig |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see ClinicalPharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. Th... |
| Active Ingredient | Acyclovir |
| Dosage Form | Tablet |
| Route | Buccal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Innocutis Holdings |
| 8 of 8 | |
|---|---|
| Drug Name | Zovirax |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Cream; Capsule; Suspension |
| Route | Oral; Topical |
| Strength | 200mg/5ml; 200mg; 800mg; 400mg; 5% |
| Market Status | Prescription |
| Company | Delcor Asset; Valeant Bermuda |
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Temad- We think of world-class quality.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Average Price (USD/KGS) |
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Drugs in Development
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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
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
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Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
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Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Sallyso 0.5 to 3.0%
Ingredient(s) : Croscarmellose Sodium
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Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant in oral solid dosage forms such as tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Solvostar 2% to 8%
Ingredient(s) : Sodium Starch Glycolate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Softgels
Grade : Oral
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Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
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ABOUT THIS PAGE
59
PharmaCompass offers a list of Aciclovir 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 Aciclovir manufacturer or Aciclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aciclovir manufacturer or Aciclovir supplier.
PharmaCompass also assists you with knowing the Aciclovir API Price utilized in the formulation of products. Aciclovir API Price is not always fixed or binding as the Aciclovir Price is obtained through a variety of data sources. The Aciclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sitavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitavir, including repackagers and relabelers. The FDA regulates Sitavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitavir 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 Sitavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitavir supplier is an individual or a company that provides Sitavir active pharmaceutical ingredient (API) or Sitavir finished formulations upon request. The Sitavir suppliers may include Sitavir API manufacturers, exporters, distributors and traders.
click here to find a list of Sitavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sitavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Sitavir active pharmaceutical ingredient (API) in detail. Different forms of Sitavir DMFs exist exist since differing nations have different regulations, such as Sitavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sitavir DMF submitted to regulatory agencies in the US is known as a USDMF. Sitavir USDMF includes data on Sitavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sitavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sitavir 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 Sitavir Drug Master File in Japan (Sitavir JDMF) empowers Sitavir 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 Sitavir JDMF during the approval evaluation for pharmaceutical products. At the time of Sitavir 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 Sitavir 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 Sitavir Drug Master File in Korea (Sitavir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sitavir. The MFDS reviews the Sitavir KDMF as part of the drug registration process and uses the information provided in the Sitavir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sitavir 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 Sitavir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sitavir suppliers with KDMF on PharmaCompass.
A Sitavir CEP of the European Pharmacopoeia monograph is often referred to as a Sitavir Certificate of Suitability (COS). The purpose of a Sitavir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sitavir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sitavir to their clients by showing that a Sitavir CEP has been issued for it. The manufacturer submits a Sitavir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sitavir CEP holder for the record. Additionally, the data presented in the Sitavir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sitavir DMF.
A Sitavir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sitavir 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 Sitavir suppliers with CEP (COS) on PharmaCompass.
A Sitavir written confirmation (Sitavir WC) is an official document issued by a regulatory agency to a Sitavir manufacturer, verifying that the manufacturing facility of a Sitavir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sitavir APIs or Sitavir finished pharmaceutical products to another nation, regulatory agencies frequently require a Sitavir WC (written confirmation) as part of the regulatory process.
click here to find a list of Sitavir 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 Sitavir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sitavir 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 Sitavir 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 Sitavir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sitavir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sitavir suppliers with NDC on PharmaCompass.
Sitavir 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 Sitavir 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 Sitavir GMP manufacturer or Sitavir GMP API supplier for your needs.
A Sitavir CoA (Certificate of Analysis) is a formal document that attests to Sitavir's compliance with Sitavir specifications and serves as a tool for batch-level quality control.
Sitavir CoA mostly includes findings from lab analyses of a specific batch. For each Sitavir 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.
Sitavir may be tested according to a variety of international standards, such as European Pharmacopoeia (Sitavir EP), Sitavir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sitavir USP).
