Opatanol

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ACTIVE PHARMA INGREDIENTS

53 API Suppliers, 17 USDMF, 9 JDMF, 8 EU WC, 14 KDMF, 15 NDC API, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers, 37 FDA Orange Book, 29 Europe, 11 Canada, 5 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE, SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE, SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE, SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 3 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 10 BASF, 1 Clariant, 10 Corel Pharma Chem, 1 Finar, 6 Gangwal Chemicals, 3 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 4 Microlex e.U, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

36 Coating Systems & Additives, 31 Fillers, Diluents & Binders, 14 Direct Compression, 14 Controlled & Modified Release, 14 Parenteral, 13 Chewable & Orodispersible Aids, 12 Taste Masking, 11 Solubilizers, 10 Granulation, 9 Disintegrants & Superdisintegrants, 7 Thickeners and Stabilizers, 6 Film Formers & Plasticizers, 5 Co-Processed Excipients, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Rheology Modifiers, 3 Topical, 2 Coloring Agents, 1 Surfactant & Foaming Agents, 1 Emulsifying Agents, 1 Lubricants & Glidants

DIGITAL CONTENT

51 News #PharmaBuzz

51 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 8 Regulatory FDF Prices, 19 Annual Reports

MARKET PLACE

20 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 1 US Exclusivities, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

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USFDA APPLICATION NUMBER - 21545 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OLOPATADINE HYDROCHLORIDE(UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)	OLOPATADINE	2mg in 1

Inactive Ingredients

Ingredient Name	Alcon Laboratories, Inc.	Apotex Corp.	Aurobindo Pharma Limited	Cipla USA Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Sandoz Inc	Teva Pharmaceuticals USA, Inc.
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
EDETATE DISODIUM(7FLD91C86K)
HYDROCHLORIC ACID (QTT17582CB)
HYDROCHLORIC ACID(QTT17582CB)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SODIUM CHLORIDE (451W47IQ8X)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (GR686LBA74)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(GR686LBA74)
WATER(059QF0KO0R)

Drug Product Composition: Opatanol

Opatanol

Opatanol

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

53 API Suppliers

17 USDMF

9 JDMF

8 EU WC

14 KDMF

15 NDC API

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers

37 FDA Orange Book

29 Europe

11 Canada

5 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE

SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE

SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE

SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

3 DKSH

4 Boai NKY Pharmaceuticals Ltd

1 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

5 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

10 BASF

1 Clariant

10 Corel Pharma Chem

1 Finar

6 Gangwal Chemicals

3 Ideal Cures

1 Ingredion Pharma Solutions

10 Kerry

3 Kima Chemical

6 Lonza Capsugel

4 Microlex e.U

2 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

3 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

36 Coating Systems & Additives

31 Fillers, Diluents & Binders

14 Direct Compression

14 Controlled & Modified Release

14 Parenteral

13 Chewable & Orodispersible Aids

12 Taste Masking

11 Solubilizers

10 Granulation

9 Disintegrants & Superdisintegrants

SPRAY, METERED;NASAL - 0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons