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Drug Approvals by the Medicines Control Council in South Africa containing Olopatadine Hydrochloride. Original Data : South African Medicines Price Registry

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Product

Olopatadine Hydrochloride
South Africa

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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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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Olopatadine Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 17 USDMF, 9 JDMF, 7 EU WC, 13 KDMF, 14 NDC API, 22 Listed Suppliers, $ API Reference Price

37 API Suppliers
17 USDMF
9 JDMF
7 EU WC
13 KDMF
14 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

11 API Suppliers

11 API Suppliers

FINISHED DOSAGE FORMULATIONS

85 FDF Dossiers, 34 FDA Orange Book, 13 Europe, 13 Canada, 5 South Africa, 20 Listed Dossiers

85 FDF Dossiers
34 FDA Orange Book
13 Europe
13 Canada
5 South Africa
20 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

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

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 1 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 2 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 1 Clariant, 10 Corel Pharma Chem, 1 Finar, 6 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 14 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, 2 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

40 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 20 Controlled & Modified Release, 16 Direct Compression, 13 Parenteral, 11 Taste Masking, 11 Solubilizers, 11 Chewable & Orodispersible Aids, 10 Granulation, 7 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Thickeners and Stabilizers, 3 Topical, 2 Coloring Agents, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Emulsifying Agents, 1 Lubricants & Glidants

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 45 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
45 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 12 Finished Drug Prices, 17 Annual Reports

2 US Medicaid Prescriptions
12 Finished Drug Prices
17 Annual Reports

MARKET PLACE

18 APIs, 5 FDF Dossiers

18 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

16 US Patents
1 US Exclusivities
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 3 Others

1 USP
3 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

$ API Ref.Price (USD/KG) : 7,209 Xls

Filters

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5 All

01 1Activo Health (Pty) Ltd

02 2Gen-Eye (Pty) Ltd

03 1Glenmark Pharmaceuticals South Africa (Pty) Ltd

04 1Novartis South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 5Olopatadine

filter Dosage Form Reset all filters

5 All

01 1NAS

02 3OPD

03 1TAB

filter Brand Name Reset all filters

5 All

01 1OLOPAGEN

02 1OLOPAGEN ONCE DAILY

03 1Olotivo

04 1Patanol

05 1RYALTRIS

Seqens Olopatadine Hydrochloride

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

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Product Main Page

01

Activo Health (Pty) Ltd

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Activo Health (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Olopatadine

Brand Name : Olotivo

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Gen-Eye (Pty) Ltd

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Gen-Eye (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Olopatadine

Brand Name : OLOPAGEN

Dosage Form : OPD

Dosage Strength : 1mg/ml

Packaging : 1X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Gen-Eye (Pty) Ltd

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Gen-Eye (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Olopatadine

Brand Name : OLOPAGEN ONCE DAILY

Dosage Form : OPD

Dosage Strength : 2mg/ml

Packaging : 1X3mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Glenmark Pharmaceuticals South Africa (P...

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Glenmark Pharmaceuticals South Africa (P...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Olopatadine

Brand Name : RYALTRIS

Dosage Form : NAS

Dosage Strength : 600µg/spray

Packaging : 120X1µg/spray

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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Corporate PDF

05

Novartis South Africa (Pty) Ltd

Country

Discovery on Target

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

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Country

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Regulatory Info : Originator

Registration Country : South Africa

Olopatadine

Brand Name : Patanol

Dosage Form : OPD

Dosage Strength : 1mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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