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    Chemistry

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    Also known as:
    Molecular Formula
    C8H11N5O3
    Molecular Weight
    225.20  g/mol
    InChI Key
    MKUXAQIIEYXACX-UHFFFAOYSA-N
    Acyclovir
    1 2D Structure

    Acyclovir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-amino-9-(2-hydroxyethoxymethyl)-3H-purin-6-one
    2.1.2 InChI
    InChI=1S/C8H11N5O3/c9-8-11-6-5(7(15)12-8)10-3-13(6)4-16-2-1-14/h3,14H,1-2,4H2,(H3,9,11,12,15)
    2.1.3 InChI Key
    MKUXAQIIEYXACX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=NC2=C(N1COCCO)NC(=NC2=O)N
    2.1.5 Isomeric SMILES
    C1=NC2=C(N1COCCO)NC(=NC2=O)N
    2.2 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 225.20 g/mol
    Molecular Formula C8H11N5O3
    XLogP3-1.6
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count4
    Exact Mass225.08618923 g/mol
    Monoisotopic Mass225.08618923 g/mol
    Topological Polar Surface Area115 A^2
    Heavy Atom Count16
    Formal Charge0
    Complexity308
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameAcyclovir
    PubMed HealthAcyclovir
    Drug ClassesAntiviral
    Drug LabelZOVIRAX 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 IngredientAcyclovir
    Dosage FormOintment; Tablet; Capsule; Suspension
    RouteTopical; Oral
    Strength5%; 200mg/5ml; 200mg; 800mg; 400mg
    Market StatusPrescription
    CompanyAmneal 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 NameAcyclovir sodium
    PubMed HealthAcyclovir
    Drug ClassesAntiviral
    Drug LabelAcyclovir 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 IngredientAcyclovir sodium
    Dosage FormInjectable
    RouteInjection
    Strengtheq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial
    Market StatusPrescription
    CompanyBedford; Fresenius Kabi Usa; Aurobindo Pharma

    3 of 8  
    Drug NameSitavig
    PubMed HealthAcyclovir
    Drug ClassesAntiviral
    Drug LabelSITAVIG (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 IngredientAcyclovir
    Dosage FormTablet
    RouteBuccal
    Strength50mg
    Market StatusPrescription
    CompanyInnocutis Holdings

    4 of 8  
    Drug NameZovirax
    Drug LabelZOVIRAX 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 IngredientAcyclovir
    Dosage FormOintment; Tablet; Cream; Capsule; Suspension
    RouteOral; Topical
    Strength200mg/5ml; 200mg; 800mg; 400mg; 5%
    Market StatusPrescription
    CompanyDelcor Asset; Valeant Bermuda

    5 of 8  
    Drug NameAcyclovir
    PubMed HealthAcyclovir
    Drug ClassesAntiviral
    Drug LabelZOVIRAX 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 IngredientAcyclovir
    Dosage FormOintment; Tablet; Capsule; Suspension
    RouteTopical; Oral
    Strength5%; 200mg/5ml; 200mg; 800mg; 400mg
    Market StatusPrescription
    CompanyAmneal 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 NameAcyclovir sodium
    PubMed HealthAcyclovir
    Drug ClassesAntiviral
    Drug LabelAcyclovir 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 IngredientAcyclovir sodium
    Dosage FormInjectable
    RouteInjection
    Strengtheq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial
    Market StatusPrescription
    CompanyBedford; Fresenius Kabi Usa; Aurobindo Pharma

    7 of 8  
    Drug NameSitavig
    PubMed HealthAcyclovir
    Drug ClassesAntiviral
    Drug LabelSITAVIG (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 IngredientAcyclovir
    Dosage FormTablet
    RouteBuccal
    Strength50mg
    Market StatusPrescription
    CompanyInnocutis Holdings

    8 of 8  
    Drug NameZovirax
    Drug LabelZOVIRAX 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 IngredientAcyclovir
    Dosage FormOintment; Tablet; Cream; Capsule; Suspension
    RouteOral; Topical
    Strength200mg/5ml; 200mg; 800mg; 400mg; 5%
    Market StatusPrescription
    CompanyDelcor Asset; Valeant Bermuda

    API Reference Price

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SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"ACYCLOVIR I.P.ACYCLOVIR I.P","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"ZHEJIANG ZHEBEI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"37","totalValueFC":"37345","currency":"USD","unitRateINR":"3196.8","date":"28-Apr-2025","totalValueINR":"3196800","totalValueInUsd":"37345","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"9748755","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"SANLITANG, QIANYUAN TOWN, DEQING COUNTY, ZHEJIANG, SDNF CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746642600,"product":"ACYCLOVIR ACYCLOVIR","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"HUBEI YITAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"APITORIA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"9000.00","actualQuantity":"9000","unit":"KGS","unitRateFc":"36","totalValueFC":"325328.5","currency":"USD","unitRateINR":"3079.8","date":"08-May-2025","totalValueINR":"27718200","totalValueInUsd":"325328.5","indian_port":"Vizag Sea","hs_no":"29335990","bill_no":"9936346","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"FENG CHENG YUAN SUBURBAN DISTRICT OF TIANMEN HUBEI CHINA","customerAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746988200,"product":"ACYCLOVIR SODIUM ACYCLOVIR SODIUM","address":"VILLAGE THANTHEWAL, ROPAR ROAD,","city":"","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"IMMACULE LIFESCIENCES PRIVATE LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"400","totalValueFC":"2008.2","currency":"USD","unitRateINR":"34220","date":"12-May-2025","totalValueINR":"171100","totalValueInUsd":"2008.2","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"2000714","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD SUITE 565 PAR AMUS NEW JERSEY 07652 USA, , UNITED STATES UNITED STATES","customerAddress":"VILLAGE THANTHEWAL, ROPAR ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747593000,"product":"ACYCLOVIR ACYCLOVIR","address":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower","city":"Hyderabad","supplier":"HUBEI YITAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"APITORIA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"9000.00","actualQuantity":"9000","unit":"KGS","unitRateFc":"36","totalValueFC":"328560.9","currency":"USD","unitRateINR":"3110.4","date":"19-May-2025","totalValueINR":"27993600","totalValueInUsd":"328560.9","indian_port":"Vizag Sea","hs_no":"29335990","bill_no":"2152997","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"FENG CHENG YUAN SUBURBAN DISTRICT OF TIANMEN HUBEI CHINA","customerAddress":"Floor No.22, Plot No.1, Survey No.83\/1, Galaxy Tower"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747852200,"product":"ACYCLOVIR PH.EUR","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"HETERO DRUGS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"491","totalValueFC":"9957.7","currency":"USD","unitRateINR":"42420","date":"22-May-2025","totalValueINR":"848400","totalValueInUsd":"9957.7","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"2205154","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747938600,"product":"ACYCLOVIR IP ACYCLOVIR IP","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"47","totalValueFC":"28597","currency":"USD","unitRateINR":"4060.8","date":"23-May-2025","totalValueINR":"2436480","totalValueInUsd":"28597","indian_port":"JNPT","hs_no":"29335990","bill_no":"2227316","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TONGYUANXI DAZHAN XIANJU ZHEJIANG PROVINCE, P.R. 317321 SDNF CN","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"ACYCLOVIR IP\/USP(INV#YTEASTERN20250426-IN1) ACYCLOVIR IP\/USP(INV#YTEASTERN20250426-IN1)","address":"601, 6TH FLR, MORYA LAND MARK,","city":"MALL ANDHERI [W], MUMBAI","supplier":"HUBEI YITAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"EASTERN CHEMICALS MUMBAI PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"36.1","totalValueFC":"36562.4","currency":"USD","unitRateINR":"3115.1","date":"24-May-2025","totalValueINR":"3115136","totalValueInUsd":"36562.4","indian_port":"JNPT","hs_no":"29339990","bill_no":"2254512","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TIANMEN ,HUBEI 431700,CHINA SDNF SDNF China","customerAddress":"601, 6TH FLR, MORYA LAND MARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748543400,"product":"ACYCLOVIR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ZHEJIANG CHARIOTEER PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ZYDUS LIFESCIENCES LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"54","totalValueFC":"54760.1","currency":"USD","unitRateINR":"4665.6","date":"30-May-2025","totalValueINR":"4665600","totalValueInUsd":"54760.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29335990","bill_no":"2368713","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Tongyuanxi,Dazhan Xianju Zhejiang Province SDNF China","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]
    04-Jan-2022
    30-May-2025
    KGS
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    Average Price (USD/KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    API Imports and Exports

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    (USD/KGS)    		 Number of Transactions

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    Europe

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    01

    Helvepharm AG

    France
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    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Switzerland

    Aciclovir

    Brand Name : Acyclovir Zentiva

    Dosage Form : Cream

    Dosage Strength : 50mg/g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

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    02

    Helvepharm AG

    France
    arrow
    ChemOutsourcing
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Switzerland

    Aciclovir

    Brand Name : Acyclovir Zentiva

    Dosage Form : Cream

    Dosage Strength : 50mg/g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

    Sanofi Company Banner

    Portfolio PDF

    Product Web Link

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    03

    TOWA PHARMACEUTICAL SPA

    Japan
    arrow
    CPhI WW Frankfurt
    Booth #9.2A94
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    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 Pharmaceutical

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    04

    TOWA PHARMACEUTICAL SPA

    Japan
    arrow
    CPhI WW Frankfurt
    Booth #9.2A94
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    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 Pharmaceutical

    Portfolio PDF

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    Virtual Booth

    Digital Content

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    05

    TOWA PHARMACEUTICAL SPA

    Japan
    arrow
    CPhI WW Frankfurt
    Booth #9.2A94
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTowa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

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    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    Acyclovir

    Brand Name : ACICLOVIR THINKS

    Dosage Form : Tablets

    Dosage Strength : 800 mg

    Packaging : 35 UNITS 800 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Towa Pharmaceutical

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    Digital Content

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    06

    TOWA PHARMACEUTICAL SPA

    Japan
    arrow
    CPhI WW Frankfurt
    Booth #9.2A94
    • fda
    • EDQM
    • WHO-GMP

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    Acyclovir

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    Acyclovir

    Brand Name : ACICLOVIR DOC GENERIC

    Dosage Form : Oral Suspension

    Dosage Strength : 400 mg/5 ml

    Packaging : 100 ML 8% - ORAL USE

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    Brand Name : ACICLIN

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    aciclovir

    Brand Name : Zovirax

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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

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    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

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    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

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    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

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    DOSAGE - CREAM;TOPICAL - 5%;1%

    USFDA APPLICATION NUMBER - 22436

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    ABOUT THIS PAGE

    Looking for / Acyclovir API manufacturers, exporters & distributors?

    Acyclovir manufacturers, exporters & distributors 1

    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.

    API | Excipient name

    Acyclovir

    Prestwick3_000086 Manufacturers

    A Prestwick3_000086 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000086, including repackagers and relabelers. The FDA regulates Prestwick3_000086 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000086 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 Prestwick3_000086 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Prestwick3_000086 Suppliers

    A Prestwick3_000086 supplier is an individual or a company that provides Prestwick3_000086 active pharmaceutical ingredient (API) or Prestwick3_000086 finished formulations upon request. The Prestwick3_000086 suppliers may include Prestwick3_000086 API manufacturers, exporters, distributors and traders.

    click here to find a list of Prestwick3_000086 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Prestwick3_000086 USDMF

    A Prestwick3_000086 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestwick3_000086 active pharmaceutical ingredient (API) in detail. Different forms of Prestwick3_000086 DMFs exist exist since differing nations have different regulations, such as Prestwick3_000086 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Prestwick3_000086 DMF submitted to regulatory agencies in the US is known as a USDMF. Prestwick3_000086 USDMF includes data on Prestwick3_000086's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestwick3_000086 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Prestwick3_000086 suppliers with USDMF on PharmaCompass.

    Prestwick3_000086 JDMF

    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 Prestwick3_000086 Drug Master File in Japan (Prestwick3_000086 JDMF) empowers Prestwick3_000086 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 Prestwick3_000086 JDMF during the approval evaluation for pharmaceutical products. At the time of Prestwick3_000086 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 Prestwick3_000086 suppliers with JDMF on PharmaCompass.

    Prestwick3_000086 KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Prestwick3_000086 Drug Master File in Korea (Prestwick3_000086 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick3_000086. The MFDS reviews the Prestwick3_000086 KDMF as part of the drug registration process and uses the information provided in the Prestwick3_000086 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Prestwick3_000086 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 Prestwick3_000086 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Prestwick3_000086 suppliers with KDMF on PharmaCompass.

    Prestwick3_000086 CEP

    A Prestwick3_000086 CEP of the European Pharmacopoeia monograph is often referred to as a Prestwick3_000086 Certificate of Suitability (COS). The purpose of a Prestwick3_000086 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prestwick3_000086 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prestwick3_000086 to their clients by showing that a Prestwick3_000086 CEP has been issued for it. The manufacturer submits a Prestwick3_000086 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prestwick3_000086 CEP holder for the record. Additionally, the data presented in the Prestwick3_000086 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prestwick3_000086 DMF.

    A Prestwick3_000086 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prestwick3_000086 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 Prestwick3_000086 suppliers with CEP (COS) on PharmaCompass.

    Prestwick3_000086 WC

    A Prestwick3_000086 written confirmation (Prestwick3_000086 WC) is an official document issued by a regulatory agency to a Prestwick3_000086 manufacturer, verifying that the manufacturing facility of a Prestwick3_000086 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prestwick3_000086 APIs or Prestwick3_000086 finished pharmaceutical products to another nation, regulatory agencies frequently require a Prestwick3_000086 WC (written confirmation) as part of the regulatory process.

    click here to find a list of Prestwick3_000086 suppliers with Written Confirmation (WC) on PharmaCompass.

    Prestwick3_000086 NDC

    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 Prestwick3_000086 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Prestwick3_000086 API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 Prestwick3_000086 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Prestwick3_000086 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prestwick3_000086 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Prestwick3_000086 suppliers with NDC on PharmaCompass.

    Prestwick3_000086 GMP

    Prestwick3_000086 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 Prestwick3_000086 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 Prestwick3_000086 GMP manufacturer or Prestwick3_000086 GMP API supplier for your needs.

    Prestwick3_000086 CoA

    A Prestwick3_000086 CoA (Certificate of Analysis) is a formal document that attests to Prestwick3_000086's compliance with Prestwick3_000086 specifications and serves as a tool for batch-level quality control.

    Prestwick3_000086 CoA mostly includes findings from lab analyses of a specific batch. For each Prestwick3_000086 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.

    Prestwick3_000086 may be tested according to a variety of international standards, such as European Pharmacopoeia (Prestwick3_000086 EP), Prestwick3_000086 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prestwick3_000086 USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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