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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 17 USDMF, 6 CEP/COS, 10 EU WC, 31 KDMF, 16 NDC API, 26 Listed Suppliers, $ API Reference Price

41 API Suppliers
17 USDMF
6 CEP/COS
10 EU WC
31 KDMF
16 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 94 FDA Orange Book, 51 Europe, 15 Canada, 7 South Africa, 52 Listed Dossiers

219 FDF Dossiers
94 FDA Orange Book
51 Europe
15 Canada
7 South Africa
52 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - 0.4%, SPRAY, METERED;NASAL - 15.75MG/SPRAY

drugProductComposition
SOLUTION/DROPS;OPHTHALMIC - 0.4%
SPRAY, METERED;NASAL - 15.75MG/SPRAY

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Synopsis

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KDMF

NDC API

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Listed Suppliers

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219

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Canada

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South Africa

Listed Dossiers

15DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

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US Patents

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Health Canada Patents

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311EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 74103-07-4, Ketorolac tris salt, Toradol, Acular, Ketorolac (tromethamine salt), Ketorolac tromethamine salt

Molecular Formula

C₁₉H₂₄N₂O₆

Molecular Weight

376.4 g/mol

InChI Key

BWHLPLXXIDYSNW-UHFFFAOYSA-N

FDA UNII

4EVE5946BQ

A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity.

1 2D Structure

Ketorolac Trometamol

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-amino-2-(hydroxymethyl)propane-1,3-diol;5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid

2.1.2 InChI

InChI=1S/C15H13NO3.C4H11NO3/c17-14(10-4-2-1-3-5-10)13-7-6-12-11(15(18)19)8-9-16(12)13;5-4(1-6,2-7)3-8/h1-7,11H,8-9H2,(H,18,19);6-8H,1-3,5H2

2.1.3 InChI Key

BWHLPLXXIDYSNW-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN2C(=CC=C2C(=O)C3=CC=CC=C3)C1C(=O)O.C(C(CO)(CO)N)O

2.2 Other Identifiers

2.2.1 UNII

4EVE5946BQ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Acular

2. Toradol

2.3.2 Depositor-Supplied Synonyms

1. 74103-07-4

2. Ketorolac Tris Salt

3. Toradol

4. Acular

5. Ketorolac (tromethamine Salt)

6. Ketorolac Tromethamine Salt

7. Ketorolac Trometamol

8. Acular Ls

9. Acuvail

10. Lixidol

11. Acular Pf

12. Sprix

13. Dolac

14. Tarasyn

15. Ketorolac (toradol)

16. 2-amino-2-(hydroxymethyl)propane-1,3-diol 5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylate

17. Nsc-758637

18. 4eve5946bq

19. Syntex

20. Toradol (tn)

21. (+/-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid Tris Salt

22. 2-amino-2-(hydroxymethyl)propane-1,3-diol;5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid

23. Godek

24. Acular Preservative Free

25. Ketorolac Tromethamine;ketorolac Tris Salt;rs37619 Tromethamine Salt

26. Chebi:6130

27. Smr000058461

28. Ketorolac Tromethamine [usan]

29. Tromethamine Ketorolac

30. Sr-01000075948

31. Rs-37619

32. Unii-4eve5946bq

33. Toratex

34. Droal

35. Ketorolactrissalt

36. Tora-dol

37. Ketorolac Tromethamine [usan:usp]

38. Acular (tn)

39. Mfcd00887595

40. Bppc

41. Spectrum_001578

42. Cpd000058461

43. Ketorolac Tromethamine Ophthalmic Solution

44. Prestwick0_000929

45. Prestwick1_000929

46. Prestwick2_000929

47. Prestwick3_000929

48. Spectrum2_001598

49. Spectrum3_001975

50. Spectrum4_000215

51. Spectrum5_001273

52. Ketrolac.tromethamine Salt

53. Schembl5036

54. Lopac0_000676

55. Bspbio_000838

56. Bspbio_003575

57. Kbiogr_000849

58. Kbioss_002058

59. (+-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)

60. 2-amino-2-(hydroxymethyl)propane-1,3-diol; 5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid

61. Ketorolac Tromethamine (usp)

62. Mls000069689

63. Mls001401455

64. Mls002222310

65. Divk1c_000836

66. Spectrum1503925

67. Spbio_001596

68. Spbio_003017

69. Bpbio1_000922

70. Chembl1201124

71. Dtxsid0045597

72. Hms502j18

73. Kbio1_000836

74. Kbio2_002058

75. Kbio2_004626

76. Kbio2_007194

77. Kbio3_002953

78. Rox-828

79. Rox-888

80. Ninds_000836

81. Hms1570j20

82. Hms1922k22

83. Hms2051p06

84. Hms2093m05

85. Hms2097j20

86. Hms2235n13

87. Hms3262g13

88. Hms3373m06

89. Hms3393p06

90. Hms3655e15

91. Hms3714j20

92. Ketorolac Trometamol [jan]

93. Pharmakon1600-01503925

94. Bcp02917

95. Hy-b0138

96. (+/-)-ketorolac Tromethamine Salt

97. Tox21_500676

98. Ccg-39376

99. Ketorolac Trometamol [mart.]

100. Nsc758637

101. S5698

102. Ketorolac Tromethamine [vandf]

103. Akos024386301

104. Bcp9000811

105. Ccg-101006

106. Cs-1933

107. Ketorolac Tromethamine [usp-rs]

108. Ketorolac Tromethamine [who-dd]

109. Lp00676

110. Nc00256

111. Nsc 758637

112. Idi1_000836

113. Ncgc00016159-02

114. Ncgc00016159-03

115. Ncgc00016159-04

116. Ncgc00094036-01

117. Ncgc00094036-02

118. Ncgc00094036-03

119. Ncgc00261361-01

120. 1h-pyrrolizine-1-carboxylic Acid, 5-benzoyl-2,3-dihydro, (+-)-, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)

121. As-15193

122. Ketorolac Tris Salt;ketorolac Tromethamine

123. Bcp0726000301

124. Ketorolac Tris Salt, >=99%, Crystalline

125. Ketorolac Trometamol [ep Monograph]

126. Db-055837

127. Ketorolac Trometamol For Peak Identification

128. Ketorolac Tromethamine [orange Book]

129. Eu-0100676

130. Ft-0630829

131. K0053

132. Sw197293-4

133. Ketorolac Tromethamine [usp Monograph]

134. D00813

135. K 1136

136. M02042

137. Omidria Component Ketorolac Tromethamine

138. 103k074

139. A838011

140. Ketorolac Tromethamine Component Of Omidria

141. Sr-01000946595

142. Q-201269

143. Sr-01000075948-1

144. Sr-01000075948-6

145. Sr-01000075948-8

146. Sr-01000946595-1

147. Ketorolac (+/-)-form Tromethamine Salt [mi]

148. Q27107089

149. F0001-2390

150. Ketorolac Trometamol 1.0 Mg/ml In Methanol (as Free Acid)

151. Ketorolac Trometamol, European Pharmacopoeia (ep) Reference Standard

152. Ketorolac Tromethamine, United States Pharmacopeia (usp) Reference Standard

153. Ketorolac Trometamol For Peak Identification, European Pharmacopoeia (ep) Reference Standard

154. Ketorolac Tromethamine, Pharmaceutical Secondary Standard; Certified Reference Material

155. (+/-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)

156. 1h-pyrrolizine-1-1h-pyrrolizine-1-carboxylic Acid, 5-benzoyl-2,3-dihydro, (+/-)-, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)

157. 2-amino-2-(hydroxymethyl)propane-1,3-diol (1rs)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylate

158. 5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylate; 2-hydroxyethyl-bis(hydroxymethyl)ammonium;ketorolac Tromethamine

2.3.3 Other Synonyms

1. Trometamol Ketorolac

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₄N₂O₆
Molecular Weight	376.4 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	6
Exact Mass	376.16343649 g/mol
Monoisotopic Mass	376.16343649 g/mol
Topological Polar Surface Area	146 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	430
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 10
Drug Name	Acular
PubMed Health	Ketorolac
Drug Classes	Analgesic, Central Nervous System Agent, Ophthalmologic Agent
Drug Label	ACULAR (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, comp...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.5%
Market Status	Prescription
Company	Allergan

2 of 10
Drug Name	Acular ls
PubMed Health	Ketorolac (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Structural and Molecular Formula: C19H24N2O6Mol Wt 376.40Chemical Name...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.4%
Market Status	Prescription
Company	Allergan

3 of 10
Drug Name	Acuvail
PubMed Health	Ketorolac
Drug Classes	Analgesic, Central Nervous System Agent, Ophthalmologic Agent
Drug Label	ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic aci...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.45%
Market Status	Prescription
Company	Allergan

4 of 10
Drug Name	Ketorolac tromethamine
Drug Label	Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural form...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops; Tablet; Injectable
Route	injection; Ophthalmic; Injection; Oral
Strength	0.5%; 0.4%; 30mg/ml; 60mg/2ml; 10mg; 15mg/ml
Market Status	Prescription
Company	Wockhardt; Hospira; Gland Pharma; Teva; Apotex; Sandoz; Sun Pharma Global; Fresenius Kabi Usa; Hikma Maple; Alcon Pharms; Amphastar Pharm; Sagent Pharms; Pliva; Agila Speclts; Mylan; Akorn

5 of 10
Drug Name	Sprix
Drug Label	Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is ()-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hy...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Spray, metered
Route	Nasal
Strength	15.75mg/spray
Market Status	Prescription
Company	Luitpold

6 of 10
Drug Name	Acular
PubMed Health	Ketorolac
Drug Classes	Analgesic, Central Nervous System Agent, Ophthalmologic Agent
Drug Label	ACULAR (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, comp...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.5%
Market Status	Prescription
Company	Allergan

7 of 10
Drug Name	Acular ls
PubMed Health	Ketorolac (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Structural and Molecular Formula: C19H24N2O6Mol Wt 376.40Chemical Name...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.4%
Market Status	Prescription
Company	Allergan

8 of 10
Drug Name	Acuvail
PubMed Health	Ketorolac
Drug Classes	Analgesic, Central Nervous System Agent, Ophthalmologic Agent
Drug Label	ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic aci...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.45%
Market Status	Prescription
Company	Allergan

9 of 10
Drug Name	Ketorolac tromethamine
Drug Label	Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural form...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Solution/drops; Tablet; Injectable
Route	injection; Ophthalmic; Injection; Oral
Strength	0.5%; 0.4%; 30mg/ml; 60mg/2ml; 10mg; 15mg/ml
Market Status	Prescription
Company	Wockhardt; Hospira; Gland Pharma; Teva; Apotex; Sandoz; Sun Pharma Global; Fresenius Kabi Usa; Hikma Maple; Alcon Pharms; Amphastar Pharm; Sagent Pharms; Pliva; Agila Speclts; Mylan; Akorn

10 of 10
Drug Name	Sprix
Drug Label	Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is ()-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hy...
Active Ingredient	Ketorolac tromethamine
Dosage Form	Spray, metered
Route	Nasal
Strength	15.75mg/spray
Market Status	Prescription
Company	Luitpold

4.2 Drug Indication

Investigated for use/treatment in pain (acute or chronic).

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Cyclooxygenase Inhibitors

Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)

Anti-Inflammatory Agents, Non-Steroidal

Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cyclooxygenase Inhibitor [EPC]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

5.3 Mechanism of Action

ROX-888 is a intranasal formulation of the broadly used injectible analgesic, ketorolac. It has ability to provide effective analgesia in acute medical conditions resulting in moderate-severe pain, without the disabling side effects of opioid analgesics

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CORPORATION","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1400","totalValueFC":"7068.8","currency":"USD","unitRateINR":"118020","date":"14-Jun-2024","totalValueINR":"590100","totalValueInUsd":"7068.8","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"3990205","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA MATTEO CIVITALI 1 20148 MILANO IT ALY , , ITALYSDNF ITALY","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"KETOROLAC TROMETHAMINE USP KETOROLAC TROMETHAMINE USP","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"M\/S.RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"25.81","actualQuantity":"25.81","unit":"KGS","unitRateFc":"1300","totalValueFC":"33940.4","currency":"USD","unitRateINR":"111735","date":"27-Dec-2024","totalValueINR":"2883880.35","totalValueInUsd":"33940.4","indian_port":"Madras Air","hs_no":"29333990","bill_no":"7488141","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA MATTEO CIVITALI 1 20148 MILANO IT","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"}]

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 - SOLUTION/DROPS;OPHTHALMIC - 0.4%

USFDA APPLICATION NUMBER - 21528

DOSAGE - SPRAY, METERED;NASAL - 15.75MG/SPRAY

USFDA APPLICATION NUMBER - 22382

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ABOUT THIS PAGE

Ketorolac Tromethamine Manufacturers

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

Ketorolac Tromethamine Suppliers

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

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

Ketorolac Tromethamine USDMF

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

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

click here to find a list of Ketorolac Tromethamine suppliers with USDMF on PharmaCompass.

Ketorolac Tromethamine KDMF

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

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

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

click here to find a list of Ketorolac Tromethamine suppliers with KDMF on PharmaCompass.

Ketorolac Tromethamine CEP

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

A Ketorolac Tromethamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketorolac Tromethamine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Ketorolac Tromethamine suppliers with CEP (COS) on PharmaCompass.

Ketorolac Tromethamine WC

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

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

Ketorolac Tromethamine 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 Ketorolac Tromethamine as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Ketorolac Tromethamine suppliers with NDC on PharmaCompass.

Ketorolac Tromethamine GMP

Ketorolac Tromethamine 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 Ketorolac Tromethamine 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 Ketorolac Tromethamine GMP manufacturer or Ketorolac Tromethamine GMP API supplier for your needs.

Ketorolac Tromethamine CoA

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

Ketorolac Tromethamine CoA mostly includes findings from lab analyses of a specific batch. For each Ketorolac Tromethamine 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.

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

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers

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6 CEP/COS

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31 KDMF

16 NDC API

26 Listed Suppliers

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DEVELOPMENTS

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FINISHED DOSAGE FORMULATIONS

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DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - 0.4%

SPRAY, METERED;NASAL - 15.75MG/SPRAY

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