(+-)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) | 19700 | SOLUTION/DROPS;OPHTHALMIC | 0.5%

(+/-)-5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIZINE-1-CARBOXYLIC ACID, COMPOUND WITH 2-AMINO-2-(HYDROXYMETHYL)-1,3-PROPANEDIOL (1:1)

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ACTIVE PHARMA INGREDIENTS

74 API Suppliers, 17 USDMF, 6 CEP/COS, 17 EU WC, 28 KDMF, 14 NDC API, 23 Listed Suppliers

DEVELOPMENTS

58 Drugs in Development

58 Drugs in Development

INTERMEDIATES

12 Intermediate Suppliers

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

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 84 News #PharmaBuzz

GLOBAL SALES INFORMATION

31 US Medicaid Prescriptions, 47 Regulatory FDF Prices

MARKET PLACE

52 APIs, 2 FDF Dossiers

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 - 19700 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.5%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KETOROLAC TROMETHAMINE(UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)	KETOROLAC TROMETHAMINE	5mg in 1

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Allergan, Inc.	Direct Rx	Lake Erie Medical DBA Quality Care Products LLC	Micro Labs Limited	Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals, Inc.	Proficient Rx LP	REMEDYREPACK INC.	Sun Pharma Global Inc.	Unit Dose Services	NuCare Pharmaceuticals,Inc.
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
EDETATE DISODIUM(7FLD91C86K)
hydrochloric acid(QTT17582CB)
OCTOXYNOL-40(9T1C662FKS)
SODIUM CHLORIDE(451W47IQ8X)
sodium hydroxide(55X04QC32I)
water(059QF0KO0R)

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Setid C94644d3 7b64 4f3d A0c7 12c77466a0fc Applno 19700 Form Solution Drops Ophthalmic Dosage 0 5 - Drug Product Composition: (+-)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)