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ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 8 USDMF, 7 CEP/COS, 3 JDMF, 6 EU WC, 4 KDMF, 10 NDC API, 20 Listed Suppliers, $ API Reference Price

30 API Suppliers
8 USDMF
7 CEP/COS
3 JDMF
6 EU WC
4 KDMF
10 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

60 FDF Dossiers, 38 FDA Orange Book, 3 Europe, 7 Canada, 2 South Africa, 10 Listed Dossiers

60 FDF Dossiers
38 FDA Orange Book
3 Europe
7 Canada
2 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION;OPHTHALMIC - 0.2%;10%, SUSPENSION/DROPS;OPHTHALMIC - 1%, SUSPENSION/DROPS;OPHTHALMIC - 0.12%, SUSPENSION/DROPS;OPHTHALMIC - 1%, SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3% BASE;1%, OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0.6%

drugProductComposition
SUSPENSION;OPHTHALMIC - 0.2%;10%
SUSPENSION/DROPS;OPHTHALMIC - 1%
SUSPENSION/DROPS;OPHTHALMIC - 0.12%
SUSPENSION/DROPS;OPHTHALMIC - 1%
SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3% BASE;1%
OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0.6%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 3 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 2 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 10 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 3 Finar, 8 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 14 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 1 Microlex e.U, 2 Nanjing Bold Chemical, 2 Novo Excipients, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 12 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 20 Controlled & Modified Release, 17 Solubilizers, 16 Parenteral, 12 Topical, 11 Film Formers & Plasticizers, 8 Emulsifying Agents, 6 Thickeners and Stabilizers, 6 API Stability Enhancers, 5 Empty Capsules, 5 Fillers, Diluents & Binders, 5 Direct Compression, 4 Vegetarian Capsules, 4 Taste Masking, 3 Granulation, 2 Rheology Modifiers, 2 Lubricants & Glidants, 2 Co-Processed Excipients, 2 Disintegrants & Superdisintegrants, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Chewable & Orodispersible Aids

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 10 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
10 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 5 Finished Drug Prices, 2 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
5 Finished Drug Prices
2 Annual Reports

MARKET PLACE

20 APIs, 1 FDF Dossiers

marketPlace
20 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

patents
4 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 1 JP , 1 Others

otherSolutions
3 EDQM
1 USP
1 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 BioAnalytical Methods

Symbiotec Prednisolone Acetate

Synopsis

ACTIVE PHARMA INGREDIENTS

30

API Suppliers

8

USDMF

7

CEP/COS

CEP/COS Certifications

3

JDMF

6

EU WC

4

KDMF

10

NDC API

0

VMF

20

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 1,258

MARKET PLACE

20

API

1

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

60

FDF Dossiers

38

FDA Orange Book

FDA (Orange Book)

3

Europe

7

Canada

0

Australia

2

South Africa

10

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

3

EDQM

1

USP

1

JP

1

Others

PATENTS & EXCLUSIVITIES

4

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

10

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

165,761,432

Annual Reports (USD Million)

84

Finished Drug Prices

106 RELATED EXCIPIENT COMPANIES

179EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 52-21-1, Prednisolone 21-acetate, Omnipred, Econopred, Pricortin, Cormalone

Molecular Formula

C₂₃H₃₀O₆

Molecular Weight

402.5 g/mol

InChI Key

LRJOMUJRLNCICJ-JZYPGELDSA-N

FDA UNII

8B2807733D

Prednisolone Acetate

Prednisolone Acetate is the acetate salt form of prednisolone, a synthetic glucocorticoid with anti-inflammatory and immunomodulating properties. As a glucocorticoid receptor agonist, prednisolone acetate binds to specific intracellular glucocorticoid receptors, and causes the ligand-receptor complex to be translocated to the nucleus where it initiates the transcription of glucocorticoid-responsive genes such as various cytokines and lipocortins. Lipocortins inhibit phospholipase A2, thereby blocking the release of arachidonic acid from membrane phospholipids and preventing the synthesis of prostaglandins and leukotrienes, both potent mediators of inflammation. This agent also decreases the number of circulating lymphocytes, induces cell differentiation, and stimulates apoptosis in sensitive tumor cell populations.

1 2D Structure

Prednisolone Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[2-[(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate

2.1.2 InChI

InChI=1S/C23H30O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h6,8,10,16-18,20,26,28H,4-5,7,9,11-12H2,1-3H3/t16-,17-,18-,20+,21-,22-,23-/m0/s1

2.1.3 InChI Key

LRJOMUJRLNCICJ-JZYPGELDSA-N

2.1.4 Canonical SMILES

CC(=O)OCC(=O)C1(CCC2C1(CC(C3C2CCC4=CC(=O)C=CC34C)O)C)O

2.1.5 Isomeric SMILES

CC(=O)OCC(=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)O

2.2 Other Identifiers

2.2.1 UNII

8B2807733D

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Pred Forte

2. Prednisolone 21-acetate

3. Scherisolone-kristall Suspension

2.3.2 Depositor-Supplied Synonyms

1. 52-21-1

2. Prednisolone 21-acetate

3. Omnipred

4. Econopred

5. Pricortin

6. Cormalone

7. Cortipred

8. Deltilen

9. Durapred

10. Predicort

11. Prednidoren

12. Supercortyl

13. Prenema

14. Meticortelone Acetate

15. Prednelan-n

16. Delcort-e

17. Pred Mild

18. Pred Forte

19. Flo-pred

20. Prediacortine

21. Nisolone

22. Prednisolone-21-acetate

23. Predalone 50

24. Predonine Injection

25. Nsc-10966

26. Mls000028512

27. Chebi:8380

28. [2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Acetate

29. Prednisolone (21-acetate)

30. Smr000058326

31. Econopred Plus

32. 8b2807733d

33. Nsc 10966

34. Dsstox_cid_3502

35. Dsstox_rid_77056

36. Dsstox_gsid_23502

37. Prednisoloneacetate

38. 21-acetoxy-1,4-pregnadiene-11beta,17alpha-diol-3,20-dione

39. Pred-forte

40. Cetapred Ointment

41. Pred-g Liquifilm

42. Vasocidin Ointment

43. Cas-52-21-1

44. Blephamide Liquifilm

45. Einecs 200-134-1

46. Prednisolone Acetate (omnipred)

47. Brn 3111798

48. Prednisolone Acetate [usp:jan]

49. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-

50. Econopred (tn)

51. Prednisoloni Acetas

52. Unii-8b2807733d

53. Ncgc00094765-01

54. Prednisolone-acetate

55. Pred Forte (tn)

56. Component Of Metimyd

57. Mfcd00037710

58. Sterane Im And Ia

59. Blephamide S.o.p.

60. Component Of Composone

61. Pred Forte Tm 1%

62. Opera_id_332

63. Pred-g S.o.p.

64. 11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate

65. Schembl7999

66. Chembl1152

67. Component Of Isopto Cetapred

68. 4-08-00-03468 (beilstein Handbook Reference)

69. Mls001148097

70. Mls002207146

71. Mls002548870

72. Component Of Neo-delta-cortef

73. Dtxsid3023502

74. Hms2234f18

75. Hms3259o07

76. Prednisolone Acetate [jan]

77. Prednisolone 21-acetate, >=97%

78. Prednisone Impurity L [ep]

79. 2-((8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Acetate

80. Bcp18958

81. Hy-b1214

82. Nsc10966

83. Zinc3875348

84. Prednisolone Acetate [vandf]

85. Tox21_111328

86. Prednisolone Acetate [mart.]

87. Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-, 21-acetate

88. S2570

89. Prednisolone Acetate [usp-rs]

90. Prednisolone Acetate [who-dd]

91. Prednisolone Acetate [who-ip]

92. Akos007930677

93. Akos015960469

94. Prednisolone 21-acetate [mi]

95. Pregna-1,4-diene-3,20-dione, 11-beta,17,21-trihydroxy-, 21-acetate

96. Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11beta)-

97. Tox21_111328_1

98. Ac-2176

99. Ccg-268673

100. Cs-4642

101. Db15566

102. Nc00470

103. Prednisolone Acetate (jp17/usp/inn)

104. Ncgc00021925-03

105. Ncgc00021925-05

106. Prednisolone Acetate [green Book]

107. 2-((1s,10s,11s,15s,17s,2r,14r)-14,17-dihydroxy-2,15-dimethyl-5-oxotetracyclo[8 .7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-oxoethyl Acetate

108. As-11673

109. Prednisolone Acetate [orange Book]

110. Prednisolone Acetate [ep Monograph]

111. Prednisolone Acetate [usp Impurity]

112. Prednisoloni Acetas [who-ip Latin]

113. Prednisolone Acetate [usp Monograph]

114. Prednisolone Acetate For Peak Identification

115. Metimyd Component Prednisolone Acetate

116. P1283

117. Pred-g Component Prednisolone Acetate

118. Prednisolone Impurity C [ep Impurity]

119. Cetapred Component Prednisolone Acetate

120. Sulphrin Component Prednisolone Acetate

121. Blephamide Component Prednisolone Acetate

122. C08180

123. D00980

124. Poly-pred Component Prednisolone Acetate

125. Predamide Component Prednisolone Acetate

126. Prednisolone Acetate 100 Microg/ml In Methanol

127. Prednisolone Acetate Component Of Pred-g

128. Ab00443788-11

129. Ab00443788_13

130. Prednisolone Acetate 1000 Microg/ml In Methanol

131. Prednisolone Acetate Component Of Cetapred

132. Prednisolone Acetate Component Of Metimyd

133. Prednisolone Acetate Component Of Sulphrin

134. Predsulfair Component Prednisolone Acetate

135. 037p710

136. A828982

137. Prednisolone Acetate Component Of Blephamide

138. Prednisolone Acetate Component Of Poly-pred

139. Prednisolone Acetate Component Of Predamide

140. Prednisolone Acetate Component Of Predsulfair

141. Q-201614

142. Hydrocortisone Acetate Impurity C [ep Impurity]

143. Isopto Cetapred Component Prednisolone Acetate

144. Neo-delta-cortef Component Prednisolone Acetate

145. Q27108063

146. Blephamide S.o.p. Component Prednisolone Acetate

147. Prednisolone Acetate Component Of Isopto Cetapred

148. Prednisolone Acetate Component Of Neo-delta-cortef

149. Methylprednisolone Acetate Impurity E [ep Impurity]

150. Prednisolone 21-acetate, Vetranal(tm), Analytical Standard

151. Prednisolone Acetate Component Of Blephamide S.o.p.

152. 11b,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate

153. Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-, 21-acetate

154. Prednisolone Acetate, British Pharmacopoeia (bp) Reference Standard

155. Prednisolone Acetate, European Pharmacopoeia (ep) Reference Standard

156. (11beta)-11,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl Acetate

157. 11.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate

158. 11.beta.,17-dihydroxy-3,20-dioxopregna-1,4-dien-21-yl Acetate

159. Prednisolone Acetate, United States Pharmacopeia (usp) Reference Standard

160. Pregna-1,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11.beta.)-

161. Prednisolone Acetate For Peak Identification, European Pharmacopoeia (ep) Reference Standard

162. Prednisolone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

163. [2-[(8s,9s,10r,11s,13s,14s,17r)-10,13-dimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] Ethanoate

164. Acetic Acid [2-[(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Ester

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₂₃H₃₀O₆
Molecular Weight	402.5 g/mol
XLogP3	2.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	4
Exact Mass	402.20423867 g/mol
Monoisotopic Mass	402.20423867 g/mol
Topological Polar Surface Area	101 Å²
Heavy Atom Count	29
Formal Charge	0
Complexity	827
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 10
Drug Name	Blephamide s.o.p.
PubMed Health	Prednisolone
Drug Classes	Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent
Drug Label	Flo-Pred (prednisolone acetate oral suspension) contains prednisolone which is the acetate ester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from...
Active Ingredient	sulfacetamide sodium; Prednisolone acetate
Dosage Form	Ointment
Route	Ophthalmic
Strength	0.2%; 10%
Market Status	Prescription
Company	Allergan

2 of 10
Drug Name	Flo-pred
PubMed Health	Prednisolone
Drug Classes	Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent
Drug Label	OMNIPRED (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:Established name: Prednisolone AcetateChemical name...
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension
Route	Oral
Strength	eq 15mg base/5ml
Market Status	Prescription
Company	Taro

3 of 10
Drug Name	Omnipred
PubMed Health	Prednisolone (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is a topical anti-inflammatory agent for ophthalmic use....
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	1%
Market Status	Prescription
Company	Alcon

4 of 10
Drug Name	Pred forte
Drug Label	PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12% is a topical anti-inflammatory agent for ophthalmic use. Structural Formula:...
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	1%
Market Status	Prescription
Company	Allergan

5 of 10
Drug Name	Pred mild
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	0.12%
Market Status	Prescription
Company	Allergan

6 of 10
Drug Name	Blephamide s.o.p.
PubMed Health	Prednisolone
Drug Classes	Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent
Drug Label	Flo-Pred (prednisolone acetate oral suspension) contains prednisolone which is the acetate ester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from...
Active Ingredient	sulfacetamide sodium; Prednisolone acetate
Dosage Form	Ointment
Route	Ophthalmic
Strength	0.2%; 10%
Market Status	Prescription
Company	Allergan

7 of 10
Drug Name	Flo-pred
PubMed Health	Prednisolone
Drug Classes	Endocrine-Metabolic Agent, Immune Suppressant, Ophthalmologic Agent
Drug Label	OMNIPRED (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:Established name: Prednisolone AcetateChemical name...
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension
Route	Oral
Strength	eq 15mg base/5ml
Market Status	Prescription
Company	Taro

8 of 10
Drug Name	Omnipred
PubMed Health	Prednisolone (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is a topical anti-inflammatory agent for ophthalmic use....
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	1%
Market Status	Prescription
Company	Alcon

9 of 10
Drug Name	Pred forte
Drug Label	PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12% is a topical anti-inflammatory agent for ophthalmic use. Structural Formula:...
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	1%
Market Status	Prescription
Company	Allergan

10 of 10
Drug Name	Pred mild
Active Ingredient	Prednisolone acetate
Dosage Form	Suspension/drops
Route	Ophthalmic
Strength	0.12%
Market Status	Prescription
Company	Allergan

4.2 Drug Indication

Prednisolone acetate is indicated as an anti-inflammatory or immunosuppressive agent for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, or infectious conditions. Prednisolone acetate is also indicated in organ transplant patients, as well as endocrine or neoplastic conditions.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Prednisolone acetate has a short duration of action as the half life is 2-3 hours. Corticosteroids have a wide therapeutic window as patients make require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory 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

Prednisolone acetate oral suspension given at a dose equivalent to 15mg prednisolone has a C_max of 321.1ng/hr, a T_maxof 1-2 hours, and an AUC of 1999.4ng\*hr/mL. The absorption pharmacokinetics of prednisolone acetate are not significantly different from a comparable dose of prednisolone.

Route of Elimination

Prednisolone acetate is predominantly excreted in the urine.

Volume of Distribution

The volume of distribution of the active metabolite, prednisolone, is 0.22/0.7L/kg.

Clearance

Data regarding the clearance of prednisolone acetate is not readily available.

5.5 Metabolism/Metabolites

Prednisolone acetate undergoes ester hydrolysis to [prednisolone]. After this step, the drug undergoes the normal metabolism of prednisolone. Prednisolone can be reversibly metabolized to [prednisone] which is then metabolized to 17,21-dihydroxy-pregnan-1,4,6-trien-3,11,30-trione (M-XVII), 20-dihydro-prednisone (M-V), 6hydroxy-prednisone (M-XII), 6-hydroxy-prednisone (M-XIII), or 20-dihydro-prednisone (M-IV). 20-dihydro-prednisone is metabolized to 17,20,21-trihydroxy-5-pregn-1-en-3,11-dione(M-XVIII). Prednisolone is metabolized to 6-prednisolone (M-XI), 20-dihydro-prednisolone (M-III), 20-dihydro-prednisolone (M-II), 6hydroxy-prednisolone (M-VII), or 6hydroxy-prednisolone(M-VI). 6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-X). 6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-VIII), 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-IX), and 6,11,17,21-tetrahydroxy-5-pregn-1-en-3,20-dione (M-XIV). MVIII is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XV) and then to MXIV, while MIX is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XVI) and then to MXIV. These metabolites and their glucuronide conjugates are excreted predominantly in the urine.

5.6 Biological Half-Life

Oral prednisolone acetate has a plasma half life of 2-3 hours.

5.7 Mechanism of Action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

API SUPPLIERS

01

Symbiotec Pharmalab

India

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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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Gonane Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

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03

Axplora

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Axplora- The partner of choice for complex APIs.

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Germany

Digital Content

USDMF CEP/COS

JDMF EU-WC NDC

KDMF VMF Others AUDIT

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04

EUROAPI

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

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France

Digital Content

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF ROW

AUDIT

EUROAPI Compnay Banner

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05

Transo-Pharm USA LLC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BMWS24

Not Confirmed

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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U.S.A

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Transo Pharm USA Company Banner

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06

Vamsi Labs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

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Digital Content

07

Cennet Biopharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

At Cennet, R&D lies at the core of all our medicinal pursuits.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Cennet Biopharma CB

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Digital Content

08

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

HRV Global Life Sciences

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Digital Content

09

Symbiotec Pharmalab

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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India

Digital Content

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF Others AUDIT

Symbiotec Pharmalab

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Corporate PDF

10

Symbiotec Pharmalab

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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India

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USDMF CEP/COS JDMF EU-WC

NDC

KDMF

VMF Others AUDIT

Symbiotec Pharmalab

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USDMF

01

Symbiotec Pharmalab Private Ltd

India

CPhI India 2024

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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India

Digital Content

Prednisolone Acetate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2020-05-19

Pay. Date : 2020-04-13

DMF Number : 32728

Submission : 2018-06-04

Status : Active

Type : II

Symbiotec Pharmalab

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Digital Content

Corporate PDF

02

Farmabios Spa

Germany

Axplora- The partner of choice for complex APIs.

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Germany

Digital Content

Sterile Prednisolone-21-acetate Micronized

GDUFA

DMF Review : Complete

Rev. Date : 2020-12-29

Pay. Date : 2020-09-22

DMF Number : 32896

Submission : 2018-07-16

Status : Active

Type : II

Product Web Link

Digital Content

03

Euroapi France

France

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

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France

Digital Content

Prednisolone Acetate

GDUFA

DMF Review : Complete

Rev. Date : 2023-02-01

Pay. Date : 2023-01-30

DMF Number : 3529

Submission : 1979-05-30

Status : Active

Type : II

EUROAPI Compnay Banner

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04

Schering Ag

Germany

BMWS24

Not Confirmed

05

Diosynth Bv

United Kingdom

BMWS24

Not Confirmed

06

Henan Lihua Pharmaceutical Co Ltd

China

BMWS24

Not Confirmed

07

Pfizer Inc

U.S.A

BMWS24

Not Confirmed

08

Upjohn Co

U.S.A

BMWS24

Not Confirmed

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CEP/COS

01

SYMBIOTEC PHARMALAB PRIVATE LIMITED...

India

CPhI India 2024

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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India

Digital Content

Prednisolone acetate, Micronised

Certificate Number : CEP 2018-089 - Rev 02

Status : Valid

Issue Date : 2024-07-29

Type : Chemical

Substance Number : 734

Symbiotec Pharmalab

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Corporate PDF

02

Farmabios SpA Gropello Cairoli IT

Germany

Axplora- The partner of choice for complex APIs.

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Germany

Digital Content

Prednisolone acetate, Micronised, sterile

Certificate Number : CEP 2017-286 - Rev 02

Status : Valid

Issue Date : 2024-07-25

Type : Chemical

Substance Number : 734

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Digital Content

03

Farmabios SpA Gropello Cairoli IT

Germany

Axplora- The partner of choice for complex APIs.

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Germany

Digital Content

Prednisolone acetate

Certificate Number : R0-CEP 2019-109 - Rev 00

Status : Valid

Issue Date : 2020-06-02

Type : Chemical

Substance Number : 734

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Digital Content

04

EUROAPI FRANCE Vertolaye FR

France

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

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France

Digital Content

Prednisolone acetate

Certificate Number : R1-CEP 2000-025 - Rev 06

Status : Valid

Issue Date : 2021-12-16

Type : Chemical

Substance Number : 734

EUROAPI Compnay Banner

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Digital Content

05

HENAN LIHUA PHARMACEUTICAL CO., LTD...

China

Fi Europe 2024

Not Confirmed

06

Pharmacia & Upjohn Company Kalamazo...

U.S.A

Fi Europe 2024

Not Confirmed

07

SYMBIOTICA SPECIALITY INGREDIENTS S...

Malaysia

Fi Europe 2024

Not Confirmed

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JDMF

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API Reference Price

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ANNIE BESANT ROAD, WORLI,","city":"BOMBAY ,MAHARASHTRA","supplier":"SKANT HEALTHCARE LTD.","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"TO THE ORDER","customerCountry":"ARGENTINA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1002.1","totalValueFC":"4958.7","currency":"USD","unitRateINR":72200,"date":"17-Mar-2021","totalValueINR":"361000","totalValueInUsd":"4958.7","indian_port":"BOMBAY AIR","hs_no":"29372200","bill_no":"9426942","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Micronized","supplierPort":"BOMBAY AIR","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. ANNIE BESANT ROAD, WORLI,, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"PREDNISOLONE ACETATE","year":"2021","qtr":"Q1","strtotime":1616697000,"product":"PREDNISOLONE ACETATE USP (MICRONISED)","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"REMINGTON PHARMACEUTICAL INDUSTRIES ","customerCountry":"PAKISTAN","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"546","totalValueFC":"13424.7","currency":"USD","unitRateINR":39093.599999999999,"date":"26-Mar-2021","totalValueINR":"977340","totalValueInUsd":"13424.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29372900","bill_no":"4005016","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Micronized","supplierPort":"Indore-EPZ\/SEZ","supplierAddress":"385\/2, GRAM PIGDEMBER,, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"PREDNISOLONE ACETATE","year":"2021","qtr":"Q2","strtotime":1618165800,"product":"PREDNISOLONE ACETATE USP 43 MICRONISED S TERILE - BULK DRUG *LUT ARN NO. AD270420 000342W DT: 01.04.2020","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. ANNIE BESANT ROAD, WORLI,","city":"BOMBAY ,MAHARASHTRA","supplier":"SKANT HEALTHCARE LTD.","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"TO THE ORDER","customerCountry":"COLOMBIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"1429.5","totalValueFC":"2766.8","currency":"USD","unitRateINR":102993,"date":"12-Apr-2021","totalValueINR":"205986","totalValueInUsd":"2766.8","indian_port":"BOMBAY AIR","hs_no":"29372200","bill_no":"1055994","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Micronized","supplierPort":"BOMBAY AIR","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. ANNIE BESANT ROAD, WORLI,, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"PREDNISOLONE ACETATE","year":"2021","qtr":"Q2","strtotime":1618857000,"product":"DRUGS: PREDNISOLONE ACETATE (PREDNISOLON E ACETATE USP)","address":"48, KANDIVLI INDUSTRIAL ESTATE,KANDIVLI-(WEST),","city":"MUMBAI, MAHARASHTRA.","supplier":"IPCA LABORATORIES","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"OF","customerCountry":"ARGENTINA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1136.6","totalValueFC":"3300","currency":"USD","unitRateINR":81895,"date":"20-Apr-2021","totalValueINR":"245685","totalValueInUsd":"3300","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"1245494","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"48, KANDIVLI INDUSTRIAL ESTATE,KANDIVLI-(WEST),, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"PREDNISOLONE ACETATE","year":"2021","qtr":"Q2","strtotime":1619461800,"product":"PREDNISOLONE ACETATE USP 43 MICRONISED S TERILE WE INTENT TO CLAIM REWARDS UNDER REMISSION OF DUTIES AND TAXES ON EXPORTE","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. ANNIE BESANT ROAD, WORLI,","city":"BOMBAY ,MAHARASHTRA","supplier":"SKANT HEALTHCARE LTD.","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"TO THE ORDER","customerCountry":"INDONESIA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"4456.2","totalValueFC":"646.9","currency":"USD","unitRateINR":321070,"date":"27-Apr-2021","totalValueINR":"48160.5","totalValueInUsd":"646.9","indian_port":"BOMBAY AIR","hs_no":"29372200","bill_no":"1391787","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Micronized","supplierPort":"BOMBAY AIR","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. ANNIE BESANT ROAD, WORLI,, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"PREDNISOLONE ACETATE","year":"2021","qtr":"Q2","strtotime":1621449000,"product":"PREDNISOLONE ACETATE USP BATCH NO. MLPA0","address":"1705, 4TH FLOOR, ONKAR BHAWANBHAGIRATH PALACE","city":"DELHI ,","supplier":"MAHIMA LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"SAN JOSE","customer":"GUTIS LTDA.","customerCountry":"COSTA RICA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1250","totalValueFC":"1160.4","currency":"USD","unitRateINR":85000,"date":"20-May-2021","totalValueINR":"85000","totalValueInUsd":"1160.4","indian_port":"DELHI AIR","hs_no":"29372100","bill_no":"1883736","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COSTA RICA","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"1705, 4TH FLOOR, ONKAR BHAWANBHAGIRATH PALACE, DELHI ,","customerAddress":""},{"dataSource":"API Export","activeIngredients":"PREDNISOLONE ACETATE","year":"2021","qtr":"Q2","strtotime":1621967400,"product":"PREDNISOLONE ACETATE USP (STERILE,","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"NEWARK APT\/NEW YORK","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"UNITED STATES","quantity":"0.07","actualQuantity":"70","unit":"GMS","unitRateFc":"8.5","totalValueFC":"590.6","currency":"USD","unitRateINR":618.01428571428573,"date":"26-May-2021","totalValueINR":"43261","totalValueInUsd":"590.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372100","bill_no":"4002791","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Sterile","supplierPort":"Ahmedabad-ZIPL-SEZ","supplierAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-, AHMEDABAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1623954600,"product":"METHYLPREDNISOLONE ACETATE USP (STERILE,","address":"385\/2, GRAM PIGDEMBER,NEAR HOTEL MASHAL, RAU","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"ACDIMA INTERNATIONAL TRADING","customerCountry":"EGYPT","quantity":"0.75","actualQuantity":"0.75","unit":"KGS","unitRateFc":"1750","totalValueFC":"1196.5","currency":"USD","unitRateINR":117333.33333333333,"date":"18-Jun-2021","totalValueINR":"88000","totalValueInUsd":"1196.5","indian_port":"BOMBAY AIR","hs_no":"29372900","bill_no":"2516290","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Sterile","supplierPort":"BOMBAY AIR","supplierAddress":"385\/2, GRAM PIGDEMBER,NEAR HOTEL MASHAL, RAU, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1623954600,"product":"METHYLPREDNISOLONE ACETATE USP (STERILE,","address":"385\/2, GRAM PIGDEMBER,NEAR HOTEL MASHAL, RAU","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"ACDIMA INTERNATIONAL TRADING","customerCountry":"EGYPT","quantity":"0.75","actualQuantity":"0.75","unit":"KGS","unitRateFc":"1750","totalValueFC":"1196.5","currency":"USD","unitRateINR":117333.33333333333,"date":"18-Jun-2021","totalValueINR":"88000","totalValueInUsd":"1196.5","indian_port":"BOMBAY AIR","hs_no":"29372900","bill_no":"2519302","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Sterile","supplierPort":"BOMBAY AIR","supplierAddress":"385\/2, GRAM PIGDEMBER,NEAR HOTEL MASHAL, RAU, INDORE, M.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1625423400,"product":"PREDNISOLONE ACETATE USP MICRONISED - BU LK DRUG *LUT ARN NO. AD270321067303F DT. 30.03.2021","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. ANNIE BESANT ROAD, WORLI,","city":"BOMBAY ,MAHARASHTRA","supplier":"SKANT HEALTHCARE LTD.","supplierCountry":"INDIA","foreign_port":"LIMA -","customer":"TO THE ORDER","customerCountry":"PERU","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"998.9","totalValueFC":"1931.3","currency":"USD","unitRateINR":71968,"date":"05-Jul-2021","totalValueINR":"143936","totalValueInUsd":"1931.3","indian_port":"BOMBAY AIR","hs_no":"29372200","bill_no":"2910173","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PERU","selfForZScoreResived":"Micronized","supplierPort":"BOMBAY AIR","supplierAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,DR. 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MAHARASHTRA,? 400020"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"METHYLPREDNISOLONE ACETATE MICRONIZED STERILE FOC ITEM BATCHNO.: W3211\/0 2306004","address":"PLOT No.30, GALAXY ,","city":"BENGALURU","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"STERISCIENCE SPECIALTIES PRIVATE ","customerCountry":"INDIA","quantity":"19.11","actualQuantity":"19.111","unit":"KGS","unitRateFc":"5500","totalValueFC":"108265.9","currency":"USD","unitRateINR":"476019.6","date":"26-Oct-2024","totalValueINR":"9097210.07","totalValueInUsd":"108265.9","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"6361915","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLADOLID SPAIN ES","customerAddress":"PLOT No.30, GALAXY ,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"METHYLPREDNISOLONE ACETATE MICRONIZED STERILE FOC ITEM BATCHNO.: W3211\/0 2306004","address":"PLOT No.30, GALAXY ,","city":"BENGALURU","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"STERISCIENCE SPECIALTIES PRIVATE ","customerCountry":"INDIA","quantity":"19.11","actualQuantity":"19.111","unit":"KGS","unitRateFc":"5500","totalValueFC":"108265.9","currency":"USD","unitRateINR":"476019.6","date":"28-Oct-2024","totalValueINR":"9097210.07","totalValueInUsd":"108265.9","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"6382432","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"PARQUE TECNOLOGICO DE BOECILLO PARCELA 105 47151 BOECILLO VALLADOLID SPAIN ES","customerAddress":"PLOT No.30, GALAXY ,"}]

Number of Transactions

Total Quantity (KGS)

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 - SUSPENSION;OPHTHALMIC - 0.2%;10%

USFDA APPLICATION NUMBER - 12813

DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 1%

USFDA APPLICATION NUMBER - 17011

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USFDA APPLICATION NUMBER - 17100

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USFDA APPLICATION NUMBER - 17469

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USFDA APPLICATION NUMBER - 50586

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USFDA APPLICATION NUMBER - 50612

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