Toradol, Acular, Ketorolac tris salt, Ketorolac Tromethamine

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ACTIVE PHARMA INGREDIENTS

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58 Drugs in Development

58 Drugs in Development

INTERMEDIATES

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12 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

265 FDF Dossiers, 94 FDA Orange Book, 92 Europe, 13 Canada, 9 South Africa, 57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - 0.5%, SOLUTION/DROPS;OPHTHALMIC - 0.4%, SPRAY, METERED;NASAL - 15.75MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.45%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 1 SPI Pharma, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 4 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 13 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 14 BASF, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 23 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Pharmachem, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives, 34 Fillers, Diluents & Binders, 25 Thickeners and Stabilizers, 22 Granulation, 21 Direct Compression, 21 Controlled & Modified Release, 15 Parenteral, 14 Topical, 14 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 10 Solubilizers, 10 Film Formers & Plasticizers, 9 Co-Processed Excipients, 7 API Stability Enhancers, 7 Taste Masking, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents, 2 Coloring Agents

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PATENTS & EXCLUSIVITIES

10 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 12 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 22427 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.45%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)	KETOROLAC TROMETHAMINE	4.5mg in 1

Inactive Ingredients

Ingredient Name	Akorn	Allergan, Inc.
Carboxymethylcellulose Sodium(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
Sodium Hydroxide(55X04QC32I)
Trisodium Citrate Dihydrate(B22547B95K)
Water(059QF0KO0R)

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Setid 3cea5803 A446 4d2c 9747 F3fb034332c8 Applno 22427 Form Solution Drops Ophthalmic Dosage 0 45 - Drug Product Composition: Toradol, Acular, Ketorolac tris salt, Ketorolac Tromethamine