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    Chemistry

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    Also known as:
    Molecular Formula
    C28H38N6O11S
    Molecular Weight
    666.7  g/mol
    InChI Key
    DEIYFTQMQPDXOT-UHFFFAOYSA-N
    Sildenafil Citrate
    1 2D Structure

    Sildenafil Citrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one;2-hydroxypropane-1,2,3-tricarboxylic acid
    2.1.2 InChI
    InChI=1S/C22H30N6O4S.C6H8O7/c1-5-7-17-19-20(27(4)25-17)22(29)24-21(23-19)16-14-15(8-9-18(16)32-6-2)33(30,31)28-12-10-26(3)11-13-28;7-3(8)1-6(13,5(11)12)2-4(9)10/h8-9,14H,5-7,10-13H2,1-4H3,(H,23,24,29);13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
    2.1.3 InChI Key
    DEIYFTQMQPDXOT-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCC1=NN(C2=C1NC(=NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)C)OCC)C.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.1.5 Isomeric SMILES
    CCCC1=NN(C2=C1NC(=NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)C)OCC)C.C(C(=O)O)C(CC(=O)O)(C(=O)O)O
    2.2 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 666.7 g/mol
    Molecular Formula C28H38N6O11S
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count12
    Exact Mass666.23192722 g/mol
    Monoisotopic Mass666.23192722 g/mol
    Topological Polar Surface Area250 A^2
    Heavy Atom Count46
    Formal Charge0
    Complexity1070
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameRevatio
    PubMed HealthSildenafil
    Drug ClassesAntihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator
    Drug LabelREVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunct...
    Active IngredientSildenafil citrate
    Dosage FormTablet; Solution; For suspension
    RouteOral; Intravenous
    Strengtheq 20mg base; eq 10mg base/ml; eq 10mg base/12.5ml (eq 0.8mg base/ml)
    Market StatusPrescription
    CompanyPfizer

    2 of 8  
    Drug NameSildenafil citrate
    Drug LabelVIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d...
    Active IngredientSildenafil citrate
    Dosage FormTablet
    Routeoral
    Strength25mg; 100mg; 50mg
    Market StatusTentative Approval
    CompanyMacleods Pharma

    3 of 8  
    Drug NameSildenafil citrate
    PubMed HealthSildenafil
    Drug ClassesAntihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator
    Drug LabelVIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d...
    Active IngredientSildenafil citrate
    Dosage FormTablet
    Routeoral; Oral
    Strengtheq 100mg base; 25mg; eq 50mg base; eq 20mg base; 100mg; 50mg; eq 25mg base
    Market StatusTentative Approval; Prescription
    CompanyAmneal Pharms; Mylan Pharms; Hetero Labs Ltd V; Mylan Pharma; Actavis Pharma; Apotex; Torrent Pharms; Watson Labs; Actavis Grp Ptc; Teva Pharms; Macleods Pharms; Dr Reddys Labs

    4 of 8  
    Drug NameViagra
    Drug LabelVIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d...
    Active IngredientSildenafil citrate
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 25mg base
    Market StatusPrescription
    CompanyPfizer Ireland

    5 of 8  
    Drug NameRevatio
    PubMed HealthSildenafil
    Drug ClassesAntihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator
    Drug LabelREVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunct...
    Active IngredientSildenafil citrate
    Dosage FormTablet; Solution; For suspension
    RouteOral; Intravenous
    Strengtheq 20mg base; eq 10mg base/ml; eq 10mg base/12.5ml (eq 0.8mg base/ml)
    Market StatusPrescription
    CompanyPfizer

    6 of 8  
    Drug NameSildenafil citrate
    Drug LabelVIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d...
    Active IngredientSildenafil citrate
    Dosage FormTablet
    Routeoral
    Strength25mg; 100mg; 50mg
    Market StatusTentative Approval
    CompanyMacleods Pharma

    7 of 8  
    Drug NameSildenafil citrate
    PubMed HealthSildenafil
    Drug ClassesAntihypertensive, Peripheral Vasodilator, Erectile Dysfunction Agent, Vasodilator
    Drug LabelVIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d...
    Active IngredientSildenafil citrate
    Dosage FormTablet
    Routeoral; Oral
    Strengtheq 100mg base; 25mg; eq 50mg base; eq 20mg base; 100mg; 50mg; eq 25mg base
    Market StatusTentative Approval; Prescription
    CompanyAmneal Pharms; Mylan Pharms; Hetero Labs Ltd V; Mylan Pharma; Actavis Pharma; Apotex; Torrent Pharms; Watson Labs; Actavis Grp Ptc; Teva Pharms; Macleods Pharms; Dr Reddys Labs

    8 of 8  
    Drug NameViagra
    Drug LabelVIAGRA, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Sildenafil citrate is designated chemically as 1-[[3-(6,7-d...
    Active IngredientSildenafil citrate
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 25mg base
    Market StatusPrescription
    CompanyPfizer Ireland

    API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"29.00","actualQuantity":"29","unit":"KGS","unitRateFc":"480","totalValueFC":"14187.7","currency":"USD","unitRateINR":"36912","date":"02-Apr-2022","totalValueINR":"1070448","totalValueInUsd":"14187.7","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8116984","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1648837800,"product":"SILDENAFIL CITRATE USP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"PLUS CHEMICALS","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"480","totalValueFC":"24461.6","currency":"USD","unitRateINR":"36912","date":"02-Apr-2022","totalValueINR":"1845600","totalValueInUsd":"24461.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8116984","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1648837800,"product":"SILDENAFIL CITRATE USP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"PLUS CHEMICALS","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"480","totalValueFC":"36692.4","currency":"USD","unitRateINR":"36912","date":"02-Apr-2022","totalValueINR":"2768400","totalValueInUsd":"36692.4","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8116984","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1648837800,"product":"SILDENAFIL CITRATE USP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"PLUS CHEMICALS","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"480","totalValueFC":"73384.7","currency":"USD","unitRateINR":"36912","date":"02-Apr-2022","totalValueINR":"5536800","totalValueInUsd":"73384.7","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8116984","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1648837800,"product":"SILDENAFIL CITRATE USP","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"PLUS CHEMICALS","supplierCountry":"CHINA","foreign_port":"NA","customer":"PIRAMAL PHARMA LIMITED","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"480","totalValueFC":"85615.5","currency":"USD","unitRateINR":"36912","date":"02-Apr-2022","totalValueINR":"6459600","totalValueInUsd":"85615.5","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"8116984","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661106600,"product":"RE -IMPORT SILDENAFIL CITRATE BP (BATCH NO. SCT22040102, SCT22040104, SCT22040105, SCT22040111, SCT22040112)","address":"SHOP NO-106, HENY ARCADE,,NR. YAMU NA PARK, DABHOLI GAM ROAD,","city":"SURAT,GUJARAT","supplier":"QINGDAO CHINO CINDA IMPORT AND EXPORT CO LTD","supplierCountry":"INDIA","foreign_port":"NA","customer":"AVIENCE CHEMICALS AND PHARMACEUTICALS","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"21.5","totalValueFC":"108760.3","currency":"USD","unitRateINR":"1730.8","date":"22-Aug-2022","totalValueINR":"8653750","totalValueInUsd":"108760.3","indian_port":"JNPT","hs_no":"29335990","bill_no":"2108835","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHOP NO-106, HENY ARCADE,,NR. YAMU NA PARK, DABHOLI GAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674757800,"product":"128906,SILDENAFIL CITRATE BATCH# TG7937(PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU","city":"BANGALORE,KARNATAKA","supplier":"APOTEX INC","supplierCountry":"CANADA","foreign_port":"NA","customer":"APOTEX RESEARCH PRIVATE LIMITED","customerCountry":"INDIA","quantity":"22.80","actualQuantity":"22.8","unit":"KGS","unitRateFc":"345","totalValueFC":"5897.6","currency":"CAD","unitRateINR":"21148.5","date":"27-Jan-2023","totalValueINR":"482185.8","totalValueInUsd":"5897.6","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"4369104","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681151400,"product":"REIMPORT - SILDENAFIL CITRATE (SB NO: 6344128 \/ DATE: 22.12.2022)","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"PRJSC FITOFARM","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"115","totalValueFC":"5812.9","currency":"USD","unitRateINR":"9527.8","date":"11-Apr-2023","totalValueINR":"476387.5","totalValueInUsd":"5812.9","indian_port":"MADRAS AIR","hs_no":"29359090","bill_no":"5458310","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684521000,"product":"450499 SILDENAFIL CITRATE BATCH TV9083 PHARMACEUTICAL PRODUCTS","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU","city":"BANGALORE","supplier":"APOTEX INC","supplierCountry":"CANADA","foreign_port":"TORONTO","customer":"APOTEX RESEARCH PRIVATE LIMITED","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"473.8","totalValueFC":"5381.2","currency":"CAD","unitRateINR":"29519","date":"20-May-2023","totalValueINR":"442784.79","totalValueInUsd":"5381.2","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Canada","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691173800,"product":"RE-IMPORT OF SILDENAFIL CITRATE BP ,BATCH NO.SCT23030027,SCT23030028,SCT23030031,SCT23030032 SCT23030033, MANUFACTURING MARCH 2023","address":"NA","city":"NA","supplier":"TARUISE SUPPLY CHAIN SHANGHAI CO LIMITED","supplierCountry":"INDIA","foreign_port":"NA","customer":"AVIENCE CHEMICALS AND PHARMACEUTICALS","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"21","totalValueFC":"105946.8","currency":"USD","unitRateINR":"1737.7","date":"05-Aug-2023","totalValueINR":"8776244.4","totalValueInUsd":"105946.8","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29335990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NA"},{"dataSource":"API 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Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735842600,"product":"SILDENAFIL CITRATE PH.EUR","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ALL PHARMA (SHANGHAI) TRADING CO LTD","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"48.79","actualQuantity":"48.786","unit":"KGS","unitRateFc":"175","totalValueFC":"8574.3","currency":"USD","unitRateINR":"15155","date":"03-Jan-2025","totalValueINR":"739351.83","totalValueInUsd":"8574.3","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29359090","bill_no":"7592113","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"Room 1401,BuildingA,No.319 Xianxia Room 1401,BuildingA,No.319 Xianxia SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
    03-Jan-2022
    30-Apr-2025
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    DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/M...DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/ML

    USFDA APPLICATION NUMBER - 203109

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    USFDA APPLICATION NUMBER - 21845

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    Looking for / Sildenafil Citrate API manufacturers, exporters & distributors?

    Sildenafil Citrate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Sildenafil Citrate 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 Sildenafil Citrate manufacturer or Sildenafil Citrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sildenafil Citrate manufacturer or Sildenafil Citrate supplier.

    PharmaCompass also assists you with knowing the Sildenafil Citrate API Price utilized in the formulation of products. Sildenafil Citrate API Price is not always fixed or binding as the Sildenafil Citrate Price is obtained through a variety of data sources. The Sildenafil Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Sildenafil Citrate

    sildenafil lactate Manufacturers

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

    sildenafil lactate Suppliers

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

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

    sildenafil lactate USDMF

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

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

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

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

    sildenafil lactate KDMF

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

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

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

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

    sildenafil lactate CEP

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

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

    sildenafil lactate WC

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

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

    sildenafil lactate 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 sildenafil lactate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for sildenafil lactate 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 sildenafil lactate 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 sildenafil lactate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a sildenafil lactate NDC to their finished compounded human drug products, they may choose to do so.

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

    sildenafil lactate GMP

    sildenafil lactate 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 sildenafil lactate 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 sildenafil lactate GMP manufacturer or sildenafil lactate GMP API supplier for your needs.

    sildenafil lactate CoA

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

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

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