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    Also known as: Nystatin, 34786-70-4, W1lx4t91wi, Nystatinum, Terrastatin, Nyotran
    Molecular Formula
    C47H75NO17
    Molecular Weight
    926.1  g/mol
    InChI Key
    VQOXZBDYSJBXMA-NQTDYLQESA-N
    FDA UNII
    W1LX4T91WI
    Nystatin
    Macrolide antifungal antibiotic complex produced by Streptomyces noursei, S. aureus, and other Streptomyces species. The biologically active components of the complex are nystatin A1, A2, and A3.
    1 2D Structure

    Nystatin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,3R,4R,7R,9R,11R,15S,16R,17R,18S,19E,21E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic acid
    2.1.2 InChI
    InChI=1S/C47H75NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-36(53)35(52)20-19-31(49)21-32(50)22-33(51)23-39(55)62-29(3)28(2)42(27)56/h5-6,8,10-18,27-38,40-44,46,49-54,56-58,61H,7,9,19-26,48H2,1-4H3,(H,59,60)/b6-5+,10-8+,13-11+,14-12+,17-15+,18-16+/t27-,28-,29-,30+,31+,32+,33+,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1
    2.1.3 InChI Key
    VQOXZBDYSJBXMA-NQTDYLQESA-N
    2.1.4 Canonical SMILES
    CC1C=CC=CCCC=CC=CC=CC=CC(CC2C(C(CC(O2)(CC(C(CCC(CC(CC(CC(=O)OC(C(C1O)C)C)O)O)O)O)O)O)O)C(=O)O)OC3C(C(C(C(O3)C)O)N)O
    2.1.5 Isomeric SMILES
    C[C@H]1/C=C/C=C/CC/C=C/C=C/C=C/C=C/[C@@H](C[C@H]2[C@@H]([C@H](C[C@](O2)(C[C@H]([C@@H](CC[C@H](C[C@H](C[C@H](CC(=O)O[C@H]([C@@H]([C@@H]1O)C)C)O)O)O)O)O)O)O)C(=O)O)O[C@H]3[C@H]([C@H]([C@@H]([C@H](O3)C)O)N)O
    2.2 Other Identifiers
    2.2.1 UNII
    W1LX4T91WI
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Fungicidin

    2. Mycostatin

    3. Nilstat

    4. Nystatin

    5. Nystatin A2

    6. Nystatin A3

    7. Nystatin G

    8. Stamicin

    9. Stamycin

    2.3.2 Depositor-Supplied Synonyms

    1. Nystatin

    2. 34786-70-4

    3. W1lx4t91wi

    4. Nystatinum

    5. Terrastatin

    6. Nyotran

    7. (1s,3r,4r,7r,9r,11r,15s,16r,17r,18s,19e,21e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic Acid

    8. Mikostatin

    9. L-nystatin

    10. Unii-w1lx4t91wi

    11. Nystatin A1 [mi]

    12. Chembl450895

    13. Schembl18633553

    14. Dtxsid80872323

    15. Chebi:473992

    16. Lmpk06000004

    17. Akos032963569

    18. Zinc253387941

    19. Q27292191

    20. (7r,10r)-8,9-dideoxy-28,29-dihydro-7,10-dihydroxyamphotericin B

    21. (1s,3r,4e,6e,8e,10e,14e,16e,18s,19r,20r,21s,25r,27r,29r,32r,33r,35s,37s,38r)-3-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyl-tetrahydropyran-2-yl]oxy-19,25,27,29,32,33,35,37-octahydroxy-18,20,21-trimethyl-23-oxo-22,39-dioxabicyclo[33.3.1]nonatriaconta-4,6,8,10,14,16-hexaene-38-carboxylic Acid

    22. (1s,3r,4r,7r,9r,11r,15s,16r,17r,18s,19e,21e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(3-amino-3,6-dideoxy-beta-d-mannopyranosyl)oxy]-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic Acid

    23. (1s,3r,4r,7r,9r,11r,15s,16r,17r,18s,19e,21z,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic Acid

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 926.1 g/mol
    Molecular Formula C47H75NO17
    XLogP3-0.2
    Hydrogen Bond Donor Count12
    Hydrogen Bond Acceptor Count18
    Rotatable Bond Count3
    Exact Mass925.50349992 g/mol
    Monoisotopic Mass925.50349992 g/mol
    Topological Polar Surface Area320 Ų
    Heavy Atom Count65
    Formal Charge0
    Complexity1620
    Isotope Atom Count0
    Defined Atom Stereocenter Count19
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count6
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Antibiotics, Antifungal; Antibiotics, Macrolide; Ionophores

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    MEDICATION (VET):Antifungal; growth promotant

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1208

    MEDICATION (VET): /Used in treatment of/ intestinal mycosis due to Candida albicans in poultry; occasionally orally in cats and dogs in suspected Candida intestinal overgrowth following antibiotic therapy, and also topically ... as cream or ointment on skin lesions ...

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 397

    Nystatin vaginal tablets are used as lozenges to treat oropharyngeal candidiasis since their slow dissolution rate provides prolonged oral contact. /NOT included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2226

    For more Therapeutic Uses (Complete) data for NYSTATIN (9 total), please visit the HSDB record page.

    4.2 Drug Warning

    Since it is not known whether nystatin is distributed into human milk, the drug should be used with caution in nursing women.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 543

    Adverse effects occur infrequently with oral nystatin therapy. Mild and transitory nausea, vomiting, GI distress, and diarrhea have occurred; high oral doses (e.g., greater than 5 million units daily) are most likely to produce these adverse GI effects. Hypersensitivity reactions have been reported very rarely.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 543

    Patients should be instructed to contact their physician if symptoms of irritation or sensitization occur during nystatin therapy. Patients should be warned against interrupting or discontinuing vaginal nystatin therapy during a prescribed regimen, even during menstruation or if symptomatic relief occurs after only a few days of therapy, unless otherwise instructed by their physician. Patients should be advised that adjunctive measures such as therapeutic douches are not necessary and may be inadvisable during vaginal nystatin therapy; however, cleansing douches may be used in nonpregnant women, if desired, for aesthetic effect.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 3432

    Adverse reactions to topically applied nystatin are very infrequent, even during prolonged use. Irritation has occurred rarely. Hypersensitivity reactions to nystatin have been reported only rarely; however, preservatives (eg, ethylenediamine, parabens, thimerosal) in some of the formulations are associated with a high incidence of contact dermatitis. An acneiform eruption has occurred rarely following topical application of nystatin and triamcinolone acetonide.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 3432

    For more Drug Warnings (Complete) data for NYSTATIN (9 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    Antifungal Agents

    Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

    Ionophores

    Chemical agents that increase the permeability of biological or artificial lipid membranes to specific ions. Most ionophores are relatively small organic molecules that act as mobile carriers within membranes or coalesce to form ion permeable channels across membranes. Many are antibiotics, and many act as uncoupling agents by short-circuiting the proton gradient across mitochondrial membranes. (See all compounds classified as Ionophores.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Polyenes [CS]; Polyene Antifungal [EPC]
    5.3 ATC Code

    A - Alimentary tract and metabolism

    A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

    A07A - Intestinal antiinfectives

    A07AA - Antibiotics

    A07AA02 - Nystatin

    D - Dermatologicals

    D01 - Antifungals for dermatological use

    D01A - Antifungals for topical use

    D01AA - Antibiotics

    D01AA01 - Nystatin

    G - Genito urinary system and sex hormones

    G01 - Gynecological antiinfectives and antiseptics

    G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

    G01AA - Antibiotics

    G01AA01 - Nystatin

    5.4 Absorption, Distribution and Excretion

    Nystatin penetrates eye poorly.

    American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 969

    Nystatin is poorly absorbed from the GI tract, and detectable blood concentrations are not obtained after usual doses. Following oral administration, nystatin is excreted almost entirely in feces as unchanged drug.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 543

    In healthy individuals, mean salivary nystatin concentrations in excess of those required in vitro for growth inhibition of clinically important Candida persist for approximately 2 hours after the beginning of oral dissolution of two nystatin lozenges (400,000 units) administered simultaneously.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 3432

    Not absorbed following topical application to intact skin or mucous membranes.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2225

    For more Absorption, Distribution and Excretion (Complete) data for NYSTATIN (6 total), please visit the HSDB record page.

    5.5 Mechanism of Action

    Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane. The drug is not active against organisms (e.g., bacteria) that do not contain sterols in their cell membrane. As a result of this binding, the membrane is no longer able to function as a selective barrier, and potassium and other cellular constituents are lost.

    McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 543

    ... /Antimicrobial/ agents that act directly on the cell membrane of the microorganism, affecting permeability and leading to leakage of intracellular compounds; these include ... the polyene antifungal agents nystatin ... which bind to cell-wall sterols ...

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1143

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    Nystatin

    About the Company : Antibiotice is the most important Romanian producer of generic drugs.Antibiotics mission is to transform valuable treatments in a more accessible way to improve people's lives. 13...

    Antibiotice is the most important Romanian producer of generic drugs.Antibiotics mission is to transform valuable treatments in a more accessible way to improve people's lives. 137 drug portfolio covers a wide range of therapeutic areas, product development strategy is focused today on cardiovascular medication class, anti-infective and system CNS. domestic Antibiotics differentiates the main producer of anti-infective drugs and the only manufacturer of active substances obtained by biosynthesis (Nystatin).
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    05

    Antibiotice

    Romania
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Antibiotice

    Romania
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Nystatin

    About the Company : Antibiotice is the most important Romanian producer of generic drugs.Antibiotics mission is to transform valuable treatments in a more accessible way to improve people's lives. 13...

    Antibiotice is the most important Romanian producer of generic drugs.Antibiotics mission is to transform valuable treatments in a more accessible way to improve people's lives. 137 drug portfolio covers a wide range of therapeutic areas, product development strategy is focused today on cardiovascular medication class, anti-infective and system CNS. domestic Antibiotics differentiates the main producer of anti-infective drugs and the only manufacturer of active substances obtained by biosynthesis (Nystatin).
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    06

    Antibiotice

    Romania
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Antibiotice

    Romania
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Nystatin

    About the Company : Antibiotice is the most important Romanian producer of generic drugs.Antibiotics mission is to transform valuable treatments in a more accessible way to improve people's lives. 13...

    Antibiotice is the most important Romanian producer of generic drugs.Antibiotics mission is to transform valuable treatments in a more accessible way to improve people's lives. 137 drug portfolio covers a wide range of therapeutic areas, product development strategy is focused today on cardiovascular medication class, anti-infective and system CNS. domestic Antibiotics differentiates the main producer of anti-infective drugs and the only manufacturer of active substances obtained by biosynthesis (Nystatin).
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    07

    BrightGene Bio-Medical Technology C...

    China
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    BrightGene Bio-Medical Technology C...

    China
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Nystatin

    About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special gener...

    BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FDFs with primary strategic focus on the regulated market. We have an exciting and very promising innovative pipeline including immuno-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug conjugates for solid tumor, novel non-antibody dependent tumor targeting conjugates for brain cancer and solid tumor brain-metastasis.
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    08

    Centrient Pharmaceuticals

    Netherlands
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Centrient Pharmaceuticals

    Netherlands
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Nystatin

    About the Company : Established in 1869, Centrient Pharmaceuticals is a global B2B pharmaceutical company focused on sustainable, enzymatic antibiotics, next-generation statins, and antifungals. The c...

    Established in 1869, Centrient Pharmaceuticals is a global B2B pharmaceutical company focused on sustainable, enzymatic antibiotics, next-generation statins, and antifungals. The company manufactures and markets intermediates, Active Pharmaceutical Ingredients (APIs), and finished dosage forms such as tablets and capsules. Centrient is driven by a purpose to improve lives through innovative and sustainable manufacturing, with a strong commitment to quality, reliability, and long-term partnerships with generics marketers. Note:Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    09

    Fujian Fukang Pharmaceutical

    China
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Fujian Fukang Pharmaceutical

    China
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Nystatin

    About the Company : Fujian Fukang Pharmaceutical Co., Ltd (Fukang) is located in Fuzhou-capital of Fujian province, founded in 1958, renamed Fuzhou Antibiotic General Factory in 1992 and became a whol...

    Fujian Fukang Pharmaceutical Co., Ltd (Fukang) is located in Fuzhou-capital of Fujian province, founded in 1958, renamed Fuzhou Antibiotic General Factory in 1992 and became a wholly state-owned enterprise in 1996. In 2002 it was reformed into a corporation with a variety of shareholders. Over more than 40 years Fukang is steadily growing. Starting from a single product, its current product range includes 7ACA intermediate, sterile cephalosporin API, antibiotic API, preparation and Animal Feed. As one of the top 100 pharmaceutical enterprises in China in terms of sales volume and profit.
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    10

    Guangzhou Tosun Pharmaceutical

    China
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Guangzhou Tosun Pharmaceutical

    China
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Nystatin

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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    FDF Dossiers

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    01

    Sanofi

    France
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • 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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    Digital Content Digital Content

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nystatin

    Brand Name : Mycostatin

    Dosage Form : Oral Suspension

    Dosage Strength : 100000IU

    Packaging :

    Approval Date : 18/05/1967

    Application Number : 33043

    Regulatory Info : Allowed

    Registration Country : Switzerland

    Sanofi Company Banner

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    02

    Sanofi

    France
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • 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 : PRESCRIPTION

    Registration Country : Canada

    NYSTATIN

    Brand Name : FLAGYSTATIN

    Dosage Form : OVULE

    Dosage Strength : 100000UNIT

    Packaging : 10

    Approval Date :

    Application Number : 1926829

    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

    Sanofi Company Banner

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    03

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Originator

    Registration Country : South Africa

    Nystatin

    Brand Name : Canstat Topical

    Dosage Form : CRE

    Dosage Strength : 100000u/g

    Packaging : 15X1u/g

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

    Aspen API Comapny Banner

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    04

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Nystatin

    Brand Name : Nystacid

    Dosage Form : OIN

    Dosage Strength : 100000u/g

    Packaging : 15X1u/g

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

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    05

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Regulatory Info : Generic

    Registration Country : South Africa

    Nystatin

    Brand Name : Canstat Vaginal Tablets 100 000 U/Tablet

    Dosage Form : VAT

    Dosage Strength : 100000u

    Packaging : 15X1u

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

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    06

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag South Africa
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Originator

    Registration Country : South Africa

    Nystatin

    Brand Name : Canstat Suspension

    Dosage Form : SUS

    Dosage Strength : 100000u/ml

    Packaging : 20X1u/ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

    Aspen API Comapny Banner

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    Digital Content

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    07

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag South Africa
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    Digital Content Digital Content

    Regulatory Info : Generic

    Registration Country : South Africa

    Nystatin

    Brand Name : Nystacid Oral Suspension

    Dosage Form : SUS

    Dosage Strength : 100000u/ml

    Packaging : 20X1u/ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

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    Product Web Link

    Virtual Booth

    Digital Content

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    08

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Australia

    Nystatin

    Brand Name : Mycostatin Oral Drops

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    09

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Regulatory Info :

    Registration Country : Australia

    Nystatin

    Brand Name : Nilstat

    Dosage Form :

    Dosage Strength :

    Packaging : 50

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    10

    Aspen Pharmacare Holdings

    South Africa
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Australia

    Nystatin

    Brand Name : Nilstat

    Dosage Form :

    Dosage Strength :

    Packaging : 50

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    FDA Orange Book

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    01

    DR REDDYS LABS SA

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AT

    NYSTATIN

    Brand Name : NYSTATIN

    Dosage Form : POWDER;TOPICAL

    Dosage Strength : 100,000 UNITS/GM

    Approval Date : 2004-07-15

    Application Number : 65203

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

    Dr Reddy Company Banner

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    02

    DR REDDYS

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AT

    NYSTATIN; TRIAMCINOLONE ACETONIDE

    Brand Name : NYSTATIN AND TRIAMCINOLONE ACETONIDE

    Dosage Form : OINTMENT;TOPICAL

    Dosage Strength : 100,000 UNITS/GM;0.1%

    Approval Date : 2017-01-31

    Application Number : 207741

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

    Dr Reddy Company Banner

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    03

    STRIDES PHARMA INTL

    India
    arrow
    CPhI Milan
    Booth #14D10
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : Yes

    TE Code :

    NYSTATIN

    Brand Name : NILSTAT

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1983-12-22

    Application Number : 50576

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

    Strides Pharma Science

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    04

    STRIDES PHARMA

    India
    arrow
    CPhI Milan
    Booth #14D10
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code :

    NYSTATIN; TRIAMCINOLONE ACETONIDE

    Brand Name : NYSTATIN AND TRIAMCINOLONE ACETONIDE

    Dosage Form : OINTMENT;TOPICAL

    Dosage Strength : 100,000 UNITS/GM;0.1%

    Approval Date : 2018-01-29

    Application Number : 210077

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Strides Pharma Science

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    05

    COSETTE

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    COSETTE

    U.S.A
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AT

    NYSTATIN

    Brand Name : NYSTATIN

    Dosage Form : CREAM;TOPICAL

    Dosage Strength : 100,000 UNITS/GM

    Approval Date : 1982-01-01

    Application Number : 61966

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    06

    DELCOR ASSET CORP

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    DELCOR ASSET CORP

    U.S.A
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
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    RLD : No

    TE Code :

    NYSTATIN

    Brand Name : MYCOSTATIN

    Dosage Form : POWDER;TOPICAL

    Dosage Strength : 100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-01-01

    Application Number : 60578

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    07

    FOUGERA

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    FOUGERA

    U.S.A
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code :

    NYSTATIN

    Brand Name : NYSTATIN

    Dosage Form : TABLET;VAGINAL

    Dosage Strength : 100,000 UNITS

    Approval Date : 1983-11-09

    Application Number : 62459

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    08

    PERRIGO NEW YORK

    Ireland
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    PERRIGO NEW YORK

    Ireland
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    RLD : No

    TE Code :

    NYSTATIN; TRIAMCINOLONE ACETONIDE

    Brand Name : NYSTATIN AND TRIAMCINOLONE ACETONIDE

    Dosage Form : OINTMENT;TOPICAL

    Dosage Strength : 100,000 UNITS/GM;0.1%

    Approval Date : 1985-10-10

    Application Number : 62280

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    RISING

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
    arrow

    RISING

    U.S.A
    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Digital Content Digital Content

    RLD : No

    TE Code : AT

    NYSTATIN; TRIAMCINOLONE ACETONIDE

    Brand Name : NYSTATIN AND TRIAMCINOLONE ACETONIDE

    Dosage Form : OINTMENT;TOPICAL

    Dosage Strength : 100,000 UNITS/GM;0.1%

    Approval Date : 2016-12-29

    Application Number : 206785

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    10

    TARO

    U.S.A
    AMWC Asia-TDAC
    Not Confirmed
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    TARO

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    RLD : No

    TE Code :

    NYSTATIN

    Brand Name : NYSTATIN

    Dosage Form : SUSPENSION;ORAL

    Dosage Strength : 100,000 UNITS/ML

    Approval Date : 1988-02-29

    Application Number : 62876

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Sanofi-Aventis (Switzerland) Sa

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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nystatin

    Brand Name : Mycostatin

    Dosage Form : Oral Suspension

    Dosage Strength : 100000IU

    Packaging :

    Approval Date : 18/05/1967

    Application Number : 33043

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    2Care4 Aps

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Nystatin

    Brand Name : Nystimex

    Dosage Form : Oral Suspension

    Dosage Strength : 100;000IU/ml

    Packaging :

    Approval Date : 09-09-2019

    Application Number : 28106266519

    Regulatory Info : Prescription

    Registration Country : Denmark

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    Abacus Medicine A/S

    Denmark
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    Regulatory Info : Approved

    Registration Country : Sweden

    Nystatin

    Brand Name : Nystatin Abacus Medicine

    Dosage Form : Oral Suspension

    Dosage Strength : 100000IU/ml

    Packaging :

    Approval Date : 22-11-2022

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Antibiotics Sa Sc

    Romania
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    Regulatory Info :

    Registration Country : Moldova

    Nystatin

    Brand Name : Nystatin Atb®

    Dosage Form : Vaginal Suppositories

    Dosage Strength : 100000IU

    Packaging :

    Approval Date : 26-08-2021

    Application Number :

    Regulatory Info :

    Registration Country : Moldova

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    BRISTOL-MYERS SQUIBB Srl

    U.S.A
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    Regulatory Info :

    Registration Country : Italy

    Nystatin; Triamcinolone Acetonide

    Brand Name : Assocort

    Dosage Form :

    Dosage Strength : Ung Derm 30 G  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Bristol-Myers Squibb Ab

    U.S.A
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Nystatin; Triamcinolone Acetonide

    Brand Name : Kenacombin Novum

    Dosage Form : Cream

    Dosage Strength :

    Packaging :

    Approval Date : 17-05-1995

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Dermapharm Ag

    Germany
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Nystatin

    Brand Name : Multilind

    Dosage Form : Oral Suspension

    Dosage Strength : 100000IU

    Packaging :

    Approval Date : 08/11/2005

    Application Number : 57263

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    Faes Farma Sa

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    Regulatory Info : Authorized

    Registration Country : Spain

    Triamcinolone Acetonide; Nystatin; Neomycin Sulfate

    Brand Name : Positon

    Dosage Form : Cream

    Dosage Strength : 2.5MG; 1MG; 100,000MG

    Packaging :

    Approval Date : 01-02-1970

    Application Number : 48825

    Regulatory Info : Authorized

    Registration Country : Spain

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    Orifarm AS

    Denmark
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    Regulatory Info : Marketed

    Registration Country : Norway

    Nystatin

    Brand Name : Mycostatin

    Dosage Form : Oral Suspension

    Dosage Strength : 100000IU/ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    Paranova Denmark A/S

    Denmark
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    Regulatory Info : Prescription

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    Nystatin

    Brand Name : Mycostatin

    Dosage Form : Oral Suspension

    Dosage Strength : 100;000IU/ml

    Packaging :

    Approval Date : 02-01-1992

    Application Number : 28101460791

    Regulatory Info : Prescription

    Registration Country : Denmark

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    ABOUT THIS PAGE

    Looking for 1400-61-9 / Nystatin API manufacturers, exporters & distributors?

    Nystatin manufacturers, exporters & distributors 1

    78

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

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

    API | Excipient name

    Nystatin

    Synonyms

    34786-70-4, W1lx4t91wi, Nystatinum, Terrastatin, Nyotran, (1s,3r,4r,7r,9r,11r,15s,16r,17r,18s,19e,21e,25e,27e,29e,31e,33r,35s,36r,37s)-33-[(2r,3s,4s,5s,6r)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic acid

    Cas Number

    1400-61-9

    Unique Ingredient Identifier (UNII)

    W1LX4T91WI

    About Nystatin

    Macrolide antifungal antibiotic complex produced by Streptomyces noursei, S. aureus, and other Streptomyces species. The biologically active components of the complex are nystatin A1, A2, and A3.

    MYTREX F Manufacturers

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

    MYTREX F Suppliers

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

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

    MYTREX F USDMF

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

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

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

    MYTREX F CEP

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

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

    MYTREX F WC

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

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

    MYTREX F 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 MYTREX F as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    MYTREX F GMP

    MYTREX F 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 MYTREX F GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right MYTREX F GMP manufacturer or MYTREX F GMP API supplier for your needs.

    MYTREX F CoA

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

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

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