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    Chemistry

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    Also known as: 82034-46-6, Lotemax, Alrex, Hgp-1, Inveltys, Cddd-5604
    Molecular Formula
    C24H31ClO7
    Molecular Weight
    466.9  g/mol
    InChI Key
    DMKSVUSAATWOCU-HROMYWEYSA-N
    FDA UNII
    YEH1EZ96K6
    Loteprednol Etabonate
    An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions.
    1 2D Structure

    Loteprednol Etabonate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    chloromethyl (8S,9S,10R,11S,13S,14S,17R)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-17-carboxylate
    2.1.2 InChI
    InChI=1S/C24H31ClO7/c1-4-30-21(29)32-24(20(28)31-13-25)10-8-17-16-6-5-14-11-15(26)7-9-22(14,2)19(16)18(27)12-23(17,24)3/h7,9,11,16-19,27H,4-6,8,10,12-13H2,1-3H3/t16-,17-,18-,19+,22-,23-,24-/m0/s1
    2.1.3 InChI Key
    DMKSVUSAATWOCU-HROMYWEYSA-N
    2.1.4 Canonical SMILES
    CCOC(=O)OC1(CCC2C1(CC(C3C2CCC4=CC(=O)C=CC34C)O)C)C(=O)OCCl
    2.1.5 Isomeric SMILES
    CCOC(=O)O[C@@]1(CC[C@@H]2[C@@]1(C[C@@H]([C@H]3[C@H]2CCC4=CC(=O)C=C[C@]34C)O)C)C(=O)OCCl
    2.2 Other Identifiers
    2.2.1 UNII
    YEH1EZ96K6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate, Chloromethyl

    2. Alrex

    3. Cehoac

    4. Chloromethyl 17 Ethoxycarbonyloxy 11 Hydroxy 3 Oxoandrosta 1,4 Diene 17 Carboxylate

    5. Chloromethyl 17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate

    6. Etabonate, Loteprednol

    7. Lotemax

    8. Loteprednol

    2.3.2 Depositor-Supplied Synonyms

    1. 82034-46-6

    2. Lotemax

    3. Alrex

    4. Hgp-1

    5. Inveltys

    6. Cddd-5604

    7. P-5604

    8. Cddd 5604

    9. Chloromethyl (8s,9s,10r,11s,13s,14s,17r)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthrene-17-carboxylate

    10. Chebi:31784

    11. Yeh1ez96k6

    12. Kpi-121

    13. Dsstox_cid_26468

    14. Dsstox_rid_81641

    15. Dsstox_gsid_46468

    16. (11b,17a)-17-[(ethoxycarbonyl)oxy]-11-hydroxy-3-oxo-androsta-1,4-diene-17-carboxylic Acid Chloromethyl Ester

    17. Chloromethyl 17alpha-[(ethoxycarbonyl)oxy]-11beta-hydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate

    18. Loterox

    19. Locort

    20. Lotemax (tn)

    21. Cas-82034-46-6

    22. Unii-yeh1ez96k6

    23. Hgp 1

    24. Loteprednol Etabonate [usan]

    25. Airex

    26. Loteprednol Etabonate (jan/usan)

    27. Loteprednoletabonate

    28. Ncgc00164594-01

    29. Idr-90102

    30. Idr-90103

    31. Eysuvis

    32. Loteprednol Etabonate Opphthalmic Suspension

    33. P 5604

    34. Schembl23907

    35. Mls001424221

    36. Gtpl7085

    37. Chembl1200865

    38. Dtxsid2046468

    39. Hms2051f16

    40. Hms2232j09

    41. Hms3715n06

    42. Loteprednol Etabonate [mi]

    43. Loteprednol Etabonate [usan:jan]

    44. Loteprednol Etabonate [jan]

    45. Bcp28645

    46. Zinc3920673

    47. Tox21_112219

    48. Bdbm50248301

    49. Loteprednol Etabonate [vandf]

    50. Mfcd00870765

    51. S1669

    52. Loteprednol Etabonate [mart.]

    53. Akos005145741

    54. Loteprednol Etabonate [who-dd]

    55. Tox21_112219_1

    56. Ccg-101041

    57. Cs-0900

    58. Db14596

    59. Gs-3599

    60. Nc00291

    61. Loteprednol Etabonate, >=98% (hplc)

    62. Ncgc00164594-02

    63. Chloromethyl 11beta,17-dihydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate, 17-(ethyl Carbonate)

    64. Hy-17358

    65. Smr000469178

    66. Loteprednol Etabonate [orange Book]

    67. Zylet Component Loteprednol Etabonate

    68. L0327

    69. D01689

    70. Loteprednol Etabonate Component Of Zylet

    71. Ab00698349-05

    72. Ab00698349-07

    73. Ab00698349_08

    74. 034l466

    75. Q3837481

    76. Androsta-1,4-diene-17-carboxylic Acid, 17-((ethoxycarbonyl)oxy)-11-hydroxy-3-oxo-, Chloromethyl Ester, (11.beta.,17.alpha.)-

    77. Androsta-1,4-diene-17-carboxylic Acid, 17-((ethoxycarbonyl)oxy)-11-hydroxy-3-oxo-, Chloromethyl Ester, (11beta,17alpha)-

    78. Chloromethyl (1s,2r,10s,11s,14r,15s,17s)-14-[(ethoxycarbonyl)oxy]-17-hydroxy-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-diene-14-carboxylate

    79. Chloromethyl 11.beta.,17-dihydroxy-3-oxoandrosta-1,4-diene-17.beta.-carboxylate, 17-(ethyl Carbonate)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 466.9 g/mol
    Molecular Formula C24H31ClO7
    XLogP33.9
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count7
    Exact Mass466.1758310 g/mol
    Monoisotopic Mass466.1758310 g/mol
    Topological Polar Surface Area99.1 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity882
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    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 4  
    Drug NameAlrex
    Drug LabelALREX (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.Loteprednol etabonate is a white to off-white powder.Loteprednol etabonate is represented by the following structura...
    Active IngredientLoteprednol etabonate
    Dosage FormSuspension/drops
    RouteOphthalmic
    Strength0.2%
    Market StatusPrescription
    CompanyBausch And Lomb

    2 of 4  
    Drug NameLotemax
    PubMed HealthLoteprednol (Into the eye)
    Drug ClassesOphthalmologic Agent
    Drug LabelLOTEMAX (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.Loteprednol etabonate is represented by the following struct...
    Active IngredientLoteprednol etabonate
    Dosage FormOintment; Gel; Suspension/drops
    RouteOphthalmic
    Strength0.5%
    Market StatusPrescription
    CompanyBausch And Lomb

    3 of 4  
    Drug NameAlrex
    Drug LabelALREX (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.Loteprednol etabonate is a white to off-white powder.Loteprednol etabonate is represented by the following structura...
    Active IngredientLoteprednol etabonate
    Dosage FormSuspension/drops
    RouteOphthalmic
    Strength0.2%
    Market StatusPrescription
    CompanyBausch And Lomb

    4 of 4  
    Drug NameLotemax
    PubMed HealthLoteprednol (Into the eye)
    Drug ClassesOphthalmologic Agent
    Drug LabelLOTEMAX (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.Loteprednol etabonate is represented by the following struct...
    Active IngredientLoteprednol etabonate
    Dosage FormOintment; Gel; Suspension/drops
    RouteOphthalmic
    Strength0.5%
    Market StatusPrescription
    CompanyBausch And Lomb

    4.2 Drug Indication

    A number of prescription loteprednol etabonate ophthalmic products are specifically indicated for the treatment of post-operative inflammation and pain following ocular surgery.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Loteprednol etabonate (LE) belongs to a unique class of corticosteroids with potent anti-inflammatory effects designed to be active at the site of action. Animal studies have shown that LE has a binding affinity to steroid receptors that is 4.3 times greater than dexamethasone. This particular class of steroids consists of bioactive molecules whose in-vivo transformation to non-toxic substances can be predicted from their chemistry and knowledge of enzymatic pathways in the body. Cortienic acid is an inactive metabolite of hydrocortisone and analogs of cortienic acid are also devoid of corticosteroid activity. Specifically, LE is an ester derivative of one of these analogs, cortienic acid etabonate. In particular, LE possesses a metabolically labile 17 beta-chloromethyl ester function which was designed in order to be hydrolyzed to an inactive carboxylic acid moiety. This inactive metabolite is more hydrophilic and is thus readily eliminated from the body. LE also exhibits good ocular permeation properties and good skin permeation properties.

    5.2 MeSH Pharmacological Classification

    Anti-Allergic Agents

    Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
    5.4 Absorption, Distribution and Excretion

    Absorption

    Loteprednol etabonate (LE) demonstrates good ocular permeation properties as it is lipid soluble, allowing the agent to penetrate into cells with relative ease. Results from the ocular administration of loteprednol in normal, healthy volunteers have shown that there are low or undetectable concentrations of either unchanged material or its metabolite. Following twice-daily unilateral topical ocular dosing of LE for 14 days in healthy subjects, the plasma concentrations of loteprednol etabonate were below the limit of quantitation (1 ng/mL) at all time points. These finds suggest that limited, if any, systemic absorption of LE occurs.

    Route of Elimination

    Following systemic administration to rats, loteprednol etabonate is eliminated primarily via the biliary/faecal route, with most of the dose eliminated in the form of the metabolite, PJ-90.

    Volume of Distribution

    The only data available regarding the volume of distribution of loteprednol etabonate (LE) is the volume of distribution the agent demonstrated when administered to dogs - a value of 3.7 L/kg. It has been shown, however, that the topical ocular administration of LE distributes preferentially into the cellular components of blood.

    Clearance

    Loteprednol etabonate was slowly hydrolyzed in liver at clearance rates of 0.21 +/- 0.04 and 2.41 +/- 0.13 ml/h/kg in the liver and plasma, respectively.

    5.5 Metabolism/Metabolites

    Loteprednol etabonate (LE) is readily and extensively metabolized to two inactive metabolites, PJ-90 (1-cortienic acid) and PJ-91 (1-cortienic acid etabonate). Metabolism occurs locally in ocular tissues, and to the extent that loteprednol etabonate reaches the systemic circulation, likely the liver and other tissues into which it distributes. In particular, studies have demonstrated that LE (chloromethyl 17alpha-ethoxycarbonyloxy-11beta-hydroxy-3-oxoandrosta-1,4-diene) is rapidly hydrolyzed at the location of its 17beta-chloromethyl ester function by paraoxonase 1 in human plasma at the site of administration at the level of the affected eye tissue to the 17beta-carboxylate PJ-91 metabolite and PJ-90 metabolite. Both metabolites are considered inactive.

    5.6 Biological Half-Life

    The terminal half-life of loteprednol etabonate as determined when administered intravenously at a dose of 5 mg/kg in the dog animal model is 2.8 hours.

    5.7 Mechanism of Action

    Corticosteroids like loteprednol etabonate inhibit the inflammatory response to a variety of inciting agents and likely delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation that are commonly associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. Moreover, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms. In particular, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. The use of LE subsequently treats post-operative inflammation and pain following ocular surgery by managing the prostaglandin release, recruitment and travel of neutrophils and macrophages, and production of other inflammatory mediators that are intrinsically associated with the physical trauma of surgery.

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LOTEPREDNOL ETABONATE MICRONIZED STERILE(TL # SW\/IN","address":"NEELAM CENTRE, B WING, 4TH FLOOR","city":"MUMBAI,MAHARASHTRA","supplier":"CURIA SPAIN SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"J B CHEMICALS AND PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"30","unit":"GMS","unitRateFc":"0.4","totalValueFC":"12.3","currency":"USD","unitRateINR":"35","date":"17-Apr-2025","totalValueINR":"1048.94","totalValueInUsd":"12.3","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"9536398","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARC ELA 105 47151 VALLADOLID, SPAIN Val ladolid, , Spain Spain","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746642600,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE LOTEPREDNOL ETABONATE MICRONIZED STERILE","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"CURIA SPAIN SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"MICRO LABS LTD","customerCountry":"INDIA","quantity":"3.11","actualQuantity":"3.114","unit":"KGS","unitRateFc":"29004.1","totalValueFC":"90689","currency":"USD","unitRateINR":"2481297.3","date":"08-May-2025","totalValueINR":"7726759.89","totalValueInUsd":"90689","indian_port":"Madras Air","hs_no":"29372200","bill_no":"9936095","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105, 47151 BOECILLO VALLADOLID, SPAIN","customerAddress":"NO 31, RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747333800,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE CAS NO.: 82034-46-6","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CURIA SPAIN SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.83","actualQuantity":"0.83","unit":"KGS","unitRateFc":"29017.3","totalValueFC":"24423.4","currency":"USD","unitRateINR":"2507098.3","date":"16-May-2025","totalValueINR":"2080891.63","totalValueInUsd":"24423.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372200","bill_no":"2082024","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"Parque Technologico parcela 105 Boecillo VA SDNF Spain","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747333800,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE CAS NO.: 82034-46-6IUPAC NAME: CHLOROMETHYL 17ALPHA-ETHOXYCARBONYLOXY-11BETA-HY","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CURIA SPAIN SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.35","actualQuantity":"1.35","unit":"KGS","unitRateFc":"29017.3","totalValueFC":"39724.8","currency":"USD","unitRateINR":"2507098.3","date":"16-May-2025","totalValueINR":"3384582.77","totalValueInUsd":"39724.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372200","bill_no":"2082024","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"Parque Technologico parcela 105 Boecillo VA SDNF Spain","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747333800,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE CAS NO.: 82034-46-6IUPAC NAME: CHLOROMETHYL 17ALPHA-ETHOXYCARBONYLOXY-11BETA-HY","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CURIA SPAIN SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"4.25","actualQuantity":"4.25","unit":"KGS","unitRateFc":"29017.3","totalValueFC":"125059.7","currency":"USD","unitRateINR":"2507098.3","date":"16-May-2025","totalValueINR":"10655167.98","totalValueInUsd":"125059.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372200","bill_no":"2082077","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"Parque Technologico parcela 105 Boecillo VA SDNF Spain","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758306600,"product":"AV7498 LOTEPREDNOL ETABONATE API (ZACH) (IMP LIC NO.SW\/OD\/11\/2025\/0000015164) (FOR TEST OR ANALYSIS PURPOSE ONLY)AV7498 LOTEPREDNOL ETABONATE API (ZACH) (IMP LIC NO.SW\/OD\/11","address":"208, OKHLA INDUSTRIAL ESTATE,,PHAS","city":"NEW DELHI,DELHI","supplier":"ZACH SYSTEM S A","supplierCountry":"FRANCE","foreign_port":"NANTES","customer":"MANKIND PHARMA LTD","customerCountry":"INDIA","quantity":"9.08","actualQuantity":"9.082","unit":"KGS","unitRateFc":"17861.6","totalValueFC":"163286.4","currency":"EURO","unitRateINR":"1587000","date":"20-Sep-2025","totalValueINR":"14413134","totalValueInUsd":"163286.4","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"4626054","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NANTES","supplierAddress":"Z.I. LA CROIX-CADEAU CS 10079-49242 AVRILLE CEDEX SDNF FRANCE","customerAddress":"208, OKHLA INDUSTRIAL ESTATE,,PHAS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766341800,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE LOTEPREDNOL ETABONATE MICRONIZED STERILE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"CURIA SPAIN SAU","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"AMNEAL PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"5.88","actualQuantity":"5.875","unit":"KGS","unitRateFc":"28315","totalValueFC":"168659.4","currency":"USD","unitRateINR":"2583743.8","date":"22-Dec-2025","totalValueINR":"15179494.53","totalValueInUsd":"168659.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372200","bill_no":"9","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARC ELA 105 BOECILLO SDNF ES","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
    19-Jan-2022
    22-Dec-2025
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    API Imports and Exports

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    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - OINTMENT;OPHTHALMIC - 0.5%

    USFDA APPLICATION NUMBER - 200738

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    DOSAGE - GEL;OPHTHALMIC - 0.38%

    USFDA APPLICATION NUMBER - 208219

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    Related Excipient Companies

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    Excipients by Applications

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    Disintegrants & Superdisintegrants

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    01

    Boai NKY Pharmaceuticals Ltd

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Tablet

    Grade : Oral (Pharma Grade)

    Category : Disintegrants & Superdisintegrants

    Brand Name : PolyKoVidone Ultra XL

    Application : Disintegrants & Superdisintegrants

    Excipient Details : PolyKoVidone Ultra XL is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Crospovidone

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    PolyKoVidone Ultra XL

    Excipients Web Link

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    02

    Boai NKY Pharmaceuticals Ltd

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Tablet

    Grade : Oral (Pharma Grade)

    Category : Disintegrants & Superdisintegrants

    Brand Name : PolyKoVidone Ultra XL-10

    Application : Disintegrants & Superdisintegrants

    Excipient Details : PolyKoVidone Ultra XL-10 is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Crospovidone

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    PolyKoVidone Ultra XL-10

    Excipients Web Link

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    03

    Boai NKY Pharmaceuticals Ltd

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Tablet

    Grade : Oral (Pharma Grade)

    Category : Disintegrants & Superdisintegrants

    Brand Name : PolyKoVidone XL

    Application : Disintegrants & Superdisintegrants

    Excipient Details : PolyKoVidone XL is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Crospovidone

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    PolyKoVidone XL

    Excipients Web Link

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    04

    Boai NKY Pharmaceuticals Ltd

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Tablet

    Grade : Oral (Pharma Grade)

    Category : Disintegrants & Superdisintegrants

    Brand Name : PolyKoVidone XL-10

    Application : Disintegrants & Superdisintegrants

    Excipient Details : PolyKoVidone XL-10 is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Crospovidone

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    PolyKoVidone XL-10

    Excipients Web Link

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    05

    Pharmatrans-Sanaq

    Switzerland
    Pharmapack
    Not Confirmed
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    06

    Ulanqab Kema New Material

    China
    Pharmapack
    Not Confirmed
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    07

    Novo Excipients

    India
    Pharmapack
    Not Confirmed
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    08

    Anhui Sunhere Pharmaceutical Excip...

    China
    Pharmapack
    Not Confirmed
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    09

    Ashland

    U.S.A
    Pharmapack
    Not Confirmed
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    10

    Pharmatrans-Sanaq

    Switzerland
    Pharmapack
    Not Confirmed
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    Only 10 entries up to this point, click to access all click full view read-more
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    Solubilizers

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    01

    DKSH

    Switzerland
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    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Cream / Lotion / Ointment, Ophthalmic Solution

    Grade : Topical, Parenteral

    Category : Solubilizers, Topical

    Brand Name : SYNTADEX 7702

    Application : Solubilizers, Topical

    Excipient Details : Syntadex 7702 is used as a solubilizer in ophthalmic drug products and in topical formulations such as creams, lotions, and ointments.

    Pharmacopoeia Ref : N/A

    Technical Specs : N/A

    Ingredient(s) : Petroleum Jelly Excipient

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    SYNTADEX 7702

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    02

    Gangwal Healthcare

    India
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    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral, Ophthalmic Solution, Syrup

    Grade : Oral, Ophthalmic, Injectable...

    Category : Solubilizers, Thickeners and Stabilizers

    Brand Name : Tyloxapol

    Application : Solubilizers, Thickeners and Stabilizers

    Excipient Details : Tyloxapol is used as a solubilizing, emulsifying and stabilizing agent in nebulizers, eye drops, injectables, oral syrups and topical dosage forms.

    Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...

    Technical Specs : NA

    Ingredient(s) : Tyloxapol

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    Gangwal Healthcare Tyloxapol

    Excipients Web Link

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    03

    Curia

    U.S.A
    Pharmapack
    Not Confirmed
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    04

    Actylis

    U.S.A
    Pharmapack
    Not Confirmed
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    05

    Valens Pharmachem

    India
    Pharmapack
    Not Confirmed
    arrow

    06

    Actylis

    U.S.A
    Pharmapack
    Not Confirmed
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    07

    Microlex e.U

    Austria
    Pharmapack
    Not Confirmed
    arrow

    08

    BASF

    Germany
    Pharmapack
    Not Confirmed
    arrow

    09

    Microlex e.U

    Austria
    Pharmapack
    Not Confirmed
    arrow

    10

    Gangwal Chemicals

    India
    Pharmapack
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    Parenteral

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    01

    EUROAPI

    France
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    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral

    Grade : Topical, Parenteral

    Category : Parenteral, Topical

    Brand Name : Purified Glycerin

    Application : Parenteral, Topical

    Excipient Details : Purified glycerin is used in topical dosage forms such as creams, lotions, and ointments. It is also used as a solvent in parenteral formulations.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Glycerol Excipient

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    ERUOAPI Purified Glycerin

    Excipients Web Link

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    02

    Nanjing Well Pharmaceutical

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Brand Name : Propylene Glycol

    Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

    Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Propylene Glycol

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    Nanjing Well Propylene Glycol

    Excipients Web Link

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    03

    Kirsch Pharma

    Germany
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHigh-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.

    Dosage Form : Injectable / Parenteral

    Grade : Biopharma Grade

    Category : Parenteral

    Brand Name : Sodium Chloride

    Application : Parenteral

    Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.

    Pharmacopoeia Ref : On Request

    Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...

    Ingredient(s) : Sodium Chloride Excipient

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    Sodium chloride

    Excipients Web Link

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    04

    Kirsch Pharma

    Germany
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHigh-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.

    Dosage Form : Injectable / Parenteral

    Grade : Biopharma Grade

    Category : Parenteral, Thickeners and Stabilizers

    Brand Name : EDTA.2Na, 2H2O

    Application : Parenteral, Thickeners and Stabilizers

    Excipient Details : Used as a chelating agent in cell culture media, downstream and as a chelator stabilizer in Biopharmaceutical formulations.

    Pharmacopoeia Ref : On Request

    Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...

    Ingredient(s) : Disodium Edetate Excipient

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    EDTA.2Na, 2H2O

    Excipients Web Link

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    05

    Pluviaendo

    Turkey
    Pharmapack
    Not Confirmed
    arrow

    06

    Finar

    India
    Pharmapack
    Not Confirmed
    arrow

    07

    Finar

    India
    Pharmapack
    Not Confirmed
    arrow

    08

    Actylis

    U.S.A
    Pharmapack
    Not Confirmed
    arrow

    09

    Actylis

    U.S.A
    Pharmapack
    Not Confirmed
    arrow

    10

    Actylis

    U.S.A
    Pharmapack
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    Fillers, Diluents & Binders

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    01

    EUROAPI

    France
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Calcium Lactate-Glycerol Adduct

    Application : Fillers, Diluents & Binders

    Excipient Details : Calcium lactate-glycerol adduct is used both as a stabilizer and a binder in tablet formulations.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Calcium Lactate

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    EUROAPI Calcium Lactate-Glycerol Adduct

    Excipients Web Link

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    02

    Boai NKY Pharmaceuticals Ltd

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Capsule, Tablet

    Grade : Oral (Pharma Grade)

    Category : Fillers, Diluents & Binders

    Brand Name : KoVidone® K25

    Application : Fillers, Diluents & Binders

    Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Povidone

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    KoVidone® K25

    Excipients Web Link

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    03

    Pluviaendo

    Turkey
    Pharmapack
    Not Confirmed
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    04

    Ulanqab Kema New Material

    China
    Pharmapack
    Not Confirmed
    arrow

    05

    Novo Excipients

    India
    Pharmapack
    Not Confirmed
    arrow

    06

    Ashland

    U.S.A
    Pharmapack
    Not Confirmed
    arrow

    07

    Novo Excipients

    India
    Pharmapack
    Not Confirmed
    arrow

    08

    Anhui Sunhere Pharmaceutical Excip...

    China
    Pharmapack
    Not Confirmed
    arrow

    09

    Pharmatrans-Sanaq

    Switzerland
    Pharmapack
    Not Confirmed
    arrow

    10

    Gangwal Chemicals

    India
    Pharmapack
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
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    Granulation

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    Direct Compression

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    Topical

    read-more
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    01

    EUROAPI

    France
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral

    Grade : Topical, Parenteral

    Category : Parenteral, Topical

    Brand Name : Purified Glycerin

    Application : Parenteral, Topical

    Excipient Details : Purified glycerin is used in topical dosage forms such as creams, lotions, and ointments. It is also used as a solvent in parenteral formulations.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Glycerol Excipient

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    ERUOAPI Purified Glycerin

    Excipients Web Link

    Virtual Booth

    02

    DKSH

    Switzerland
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Cream / Lotion / Ointment, Ophthalmic Solution

    Grade : Topical, Parenteral

    Category : Solubilizers, Topical

    Brand Name : SYNTADEX 7702

    Application : Solubilizers, Topical

    Excipient Details : Syntadex 7702 is used as a solubilizer in ophthalmic drug products and in topical formulations such as creams, lotions, and ointments.

    Pharmacopoeia Ref : N/A

    Technical Specs : N/A

    Ingredient(s) : Petroleum Jelly Excipient

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    SYNTADEX 7702

    Excipients Web Link

    Virtual Booth

    03

    Nanjing Well Pharmaceutical

    China
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Brand Name : Propylene Glycol

    Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical

    Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Propylene Glycol

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    Nanjing Well Propylene Glycol

    Excipients Web Link

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    04

    DKSH

    Switzerland
    arrow
    Pharmapack
    Not Confirmed
    • fda
    • EDQM
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    Excipient Details : Boric acid is used as an antimicrobial preservative in topical formulations such as creams and ointments.

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    Technical Specs : 99.9 % Boric Acid (H3BO3)

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    Tobramycin/Lotepred Etab

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    ABOUT THIS PAGE

    Looking for 82034-46-6 / Loteprednol Etabonate API manufacturers, exporters & distributors?

    Loteprednol Etabonate manufacturers, exporters & distributors 1

    89

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

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

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

    API | Excipient name

    Loteprednol Etabonate

    Synonyms

    82034-46-6, Lotemax, Alrex, Hgp-1, Inveltys, Cddd-5604

    Cas Number

    82034-46-6

    Unique Ingredient Identifier (UNII)

    YEH1EZ96K6

    About Loteprednol Etabonate

    An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions.

    Alrex;Lotemax Manufacturers

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

    Alrex;Lotemax Suppliers

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

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

    Alrex;Lotemax USDMF

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

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

    click here to find a list of Alrex;Lotemax suppliers with USDMF on PharmaCompass.

    Alrex;Lotemax KDMF

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

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

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

    click here to find a list of Alrex;Lotemax suppliers with KDMF on PharmaCompass.

    Alrex;Lotemax WC

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

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

    Alrex;Lotemax 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 Alrex;Lotemax as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Alrex;Lotemax suppliers with NDC on PharmaCompass.

    Alrex;Lotemax GMP

    Alrex;Lotemax 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 Alrex;Lotemax 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 Alrex;Lotemax GMP manufacturer or Alrex;Lotemax GMP API supplier for your needs.

    Alrex;Lotemax CoA

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

    Alrex;Lotemax CoA mostly includes findings from lab analyses of a specific batch. For each Alrex;Lotemax 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.

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