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Loteprednol Etabonate

Zach Loteprednol Etabonate

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 10 USDMF, 2 EU WC, 3 KDMF, 12 NDC API, 17 Listed Suppliers, $ API Reference Price

23 API Suppliers
10 USDMF
2 EU WC
3 KDMF
12 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

30 FDF Dossiers, 19 FDA Orange Book, 1 Europe, 4 Canada, 2 South Africa, 4 Listed Dossiers

30 FDF Dossiers
19 FDA Orange Book
1 Europe
4 Canada
2 South Africa
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;OPHTHALMIC - 0.5%, GEL;OPHTHALMIC - 0.38%

drugProductComposition
OINTMENT;OPHTHALMIC - 0.5%
GEL;OPHTHALMIC - 0.38%

RELATED EXCIPIENT COMPANIES

2 DKSH, 1 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 7 Actylis, 1 Alcedo Pharmachem, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 1 Curia, 2 Finar, 4 Gangwal Chemicals, 2 Kerry, 1 Lubrizol Life Science Health, 2 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Ulanqab Kema New Material, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

14 Disintegrants & Superdisintegrants, 14 Solubilizers, 10 Direct Compression, 10 Fillers, Diluents & Binders, 10 Parenteral, 9 Granulation, 6 Topical, 5 Controlled & Modified Release, 5 Thickeners and Stabilizers, 4 Chewable & Orodispersible Aids, 4 Film Formers & Plasticizers, 2 Co-Processed Excipients, 2 Coating Systems & Additives, 1 Emulsifying Agents, 1 Taste Masking

excipientsByApplications
14 Disintegrants & Superdisintegrants
14 Solubilizers
10 Direct Compression
10 Fillers, Diluents & Binders
10 Parenteral
9 Granulation
6 Topical
5 Controlled & Modified Release
5 Thickeners and Stabilizers
4 Chewable & Orodispersible Aids
4 Film Formers & Plasticizers
2 Co-Processed Excipients
2 Coating Systems & Additives
1 Emulsifying Agents
1 Taste Masking

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 3 Finished Drug Prices

globalSalesInformation
6 US Medicaid Prescriptions
3 Finished Drug Prices

MARKET PLACE

10 APIs, 1 FDF Dossiers

marketPlace
10 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

33 US Patents, 2 Health Canada Patents

patents
33 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

otherSolutions
2 Others

Loteprednol Etabonate

Synopsis

ACTIVE PHARMA INGREDIENTS

23

API Suppliers

10

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

2

EU WC

3

KDMF

12

NDC API

0

VMF

17

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 10,632

MARKET PLACE

10

API

1

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

30

FDF Dossiers

19

FDA Orange Book

FDA (Orange Book)

1

Europe

4

Canada

0

Australia

2

South Africa

4

Listed Dossiers

7DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

2

Others

PATENTS & EXCLUSIVITIES

33

US Patents

0

US Exclusivities

2

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

18

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

69,149,760

Annual Reports (USD Million)

NA

Finished Drug Prices

55 RELATED EXCIPIENT COMPANIES

97EXCIPIENTS BY APPLICATIONS

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 Formula	C₂₄H₃₁ClO₇
Molecular Weight	466.9 g/mol
XLogP3	3.9
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	7
Exact Mass	466.1758310 g/mol
Monoisotopic Mass	466.1758310 g/mol
Topological Polar Surface Area	99.1 Å²
Heavy Atom Count	32
Formal Charge	0
Complexity	882
Isotope Atom Count	0
Defined Atom Stereocenter Count	7
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Alrex
Drug Label	ALREX (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 Ingredient	Loteprednol etabonate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	0.2%
Market Status	Prescription
Company	Bausch And Lomb

2 of 4
Drug Name	Lotemax
PubMed Health	Loteprednol (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	LOTEMAX (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 Ingredient	Loteprednol etabonate
Dosage Form	Ointment; Gel; Suspension/drops
Route	Ophthalmic
Strength	0.5%
Market Status	Prescription
Company	Bausch And Lomb

3 of 4
Drug Name	Alrex
Drug Label	ALREX (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 Ingredient	Loteprednol etabonate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	0.2%
Market Status	Prescription
Company	Bausch And Lomb

4 of 4
Drug Name	Lotemax
PubMed Health	Loteprednol (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	LOTEMAX (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 Ingredient	Loteprednol etabonate
Dosage Form	Ointment; Gel; Suspension/drops
Route	Ophthalmic
Strength	0.5%
Market Status	Prescription
Company	Bausch 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.

API SUPPLIERS

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ZACH System SA

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Loteprednol Etabonate IH

Date of Issue : 2023-01-06

Valid Till : 2025-07-29

Written Confirmation Number : WC-0099

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NDC Package Code : 60269-287

Start Marketing Date : 1998-03-09

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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LOTEPREDNOL ETABONATE

NDC Package Code : 46439-8743

Start Marketing Date : 2012-04-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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04

Aarti Pharmalabs Limited

India

Duphat

Not Confirmed

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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India

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LOTEPREDNOL ETABONATE

NDC Package Code : 15308-0722

Start Marketing Date : 2011-06-30

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Aarti Industries Company Banner

Product Web Link

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05

Industriale Chimica s.r.l.

Italy

Duphat

Not Confirmed

06

Industriale Chimica s.r.l.

Italy

Duphat

Not Confirmed

07

Isomedix Operations Inc

U.S.A

Duphat

Not Confirmed

08

Isomedix Operations Inc

U.S.A

Duphat

Not Confirmed

09

Isomedix Operations Inc

U.S.A

Duphat

Not Confirmed

10

Isomedix Operations Inc

U.S.A

Duphat

Not Confirmed

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API Reference Price

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PRADESH","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.46","actualQuantity":"0.46","unit":"KGS","unitRateFc":"28000","totalValueFC":"13176.8","currency":"USD","unitRateINR":"2384123","date":"21-Oct-2023","totalValueINR":"1096696.58","totalValueInUsd":"13176.8","indian_port":"Hyderabad Air","hs_no":"29372200","bill_no":"8410772","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLADOLIDSDNF Spain","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706380200,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE (250G)","address":"H NO.141, SILPA BRINDAVAN,","city":"KUKATPALLY, HYDERABAD, AP.","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ORBICULAR PHARMACEUTICAL TECHNOLOGIES ","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"32000","totalValueFC":"8095.1","currency":"USD","unitRateINR":"2691200","date":"28-Jan-2024","totalValueINR":"672800","totalValueInUsd":"8095.1","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"9867816","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"Via Pavial 27027 Gropello Cairoli (PV) ITALVSDNF Italy","customerAddress":"H NO.141, SILPA BRINDAVAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706898600,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"N\/A","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"23058.8","totalValueFC":"23371.8","currency":"USD","unitRateINR":"1939245","date":"03-Feb-2024","totalValueINR":"1939245","totalValueInUsd":"23371.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372200","bill_no":"1000444","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718908200,"product":"LOTEPREDNOL ETABONATE STERILE MICRONIZED","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"26","totalValueFC":"7876.7","currency":"USD","unitRateINR":"2191.8","date":"21-Jun-2024","totalValueINR":"657540","totalValueInUsd":"7876.7","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"4108942","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN","supplierAddress":"VIA PAVIA,1-27027 GROPELLO CAIROLIPV,SDNF ITALY","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718908200,"product":"LOTEPREDNOL ETABONATE STERILE MICRONIZED","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1200","unit":"GMS","unitRateFc":"26","totalValueFC":"31506.7","currency":"USD","unitRateINR":"2191.8","date":"21-Jun-2024","totalValueINR":"2630160","totalValueInUsd":"31506.7","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"4108942","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN","supplierAddress":"VIA PAVIA,1-27027 GROPELLO CAIROLIPV,SDNF ITALY","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719167400,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"AUROBINDO PHARMA 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","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"30000","totalValueFC":"1518.8","currency":"USD","unitRateINR":"2545500","date":"03-Sep-2024","totalValueINR":"127275","totalValueInUsd":"1518.8","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29372200","bill_no":"5394928","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"Parque Tecnologico de Boecillo Parcela 105,Boecillo,Valladolid SDNF Spain","customerAddress":"PLOT NO-51,MEENAKSHI BAMBOO,GACHIB"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726079400,"product":"LOTEPREDNOL ETABONATE MICRONIZED STERILE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"15669.4","totalValueFC":"15874.8","currency":"USD","unitRateINR":"1330329","date":"12-Sep-2024","totalValueINR":"1330329","totalValueInUsd":"15874.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372200","bill_no":"1006561","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"}]

Number of Transactions

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Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - OINTMENT;OPHTHALMIC - 0.5%

USFDA APPLICATION NUMBER - 200738

DOSAGE - GEL;OPHTHALMIC - 0.38%

USFDA APPLICATION NUMBER - 208219

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ABOUT THIS PAGE

Loteprednol Etabonate Manufacturers

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

Loteprednol Etabonate Suppliers

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

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

Loteprednol Etabonate USDMF

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

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

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

Loteprednol Etabonate KDMF

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

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

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

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

Loteprednol Etabonate WC

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

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

Loteprednol Etabonate 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 Loteprednol Etabonate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Loteprednol Etabonate GMP

Loteprednol Etabonate 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 Loteprednol Etabonate 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 Loteprednol Etabonate GMP manufacturer or Loteprednol Etabonate GMP API supplier for your needs.

Loteprednol Etabonate CoA

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

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

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