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Drug Product Composition: Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 16 USDMF, 10 CEP/COS, 1 JDMF, 12 EU WC, 5 KDMF, 12 NDC API, 37 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

INTERMEDIATES

12 Intermediates Suppliers

12 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 75 FDA Orange Book, 48 Europe, 6 Canada, 11 South Africa, 22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INJECTION - 100MG/10ML (10MG/ML), SOLUTION;INJECTION - 100MG/20ML (5MG/ML), SOLUTION;INJECTION - 150MG/30ML (5MG/ML), SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML), SOLUTION;INJECTION - 1GM/200ML (5MG/ML), SOLUTION;INJECTION - 200MG/20ML (10MG/ML), SOLUTION;INJECTION - 200MG/100ML (2MG/ML), SOLUTION;INJECTION - 20MG/10ML (2MG/ML), SOLUTION;INJECTION - 400MG/200ML (2MG/ML), SOLUTION;INJECTION - 40MG/20ML (2MG/ML), SOLUTION;INJECTION - 500MG/100ML (5MG/ML), SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Actylis

3 Actylis

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices

MARKET PLACE

17 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 14 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 Others

$ Xls

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USFDA APPLICATION NUMBER - 20533 / DOSAGE - SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROPIVACAINE HYDROCHLORIDE MONOHYDRATE(UNII: V910P86109) (ROPIVACAINE - UNII:7IO5LYA57N)	ROPIVACAINE	5mg in 1

Inactive Ingredients

Ingredient Name	APP Pharmaceuticals, LLC	Mylan Institutional LLC	Sagent Pharmaceuticals
hydrochloric acid(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
water(059QF0KO0R)

Drug Product Composition: Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers

16 USDMF

10 CEP/COS

1 JDMF

12 EU WC

5 KDMF

12 NDC API

37 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

INTERMEDIATES

12 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers

75 FDA Orange Book

48 Europe

6 Canada

11 South Africa

22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INJECTION - 100MG/10ML (10MG/ML)

SOLUTION;INJECTION - 100MG/20ML (5MG/ML)

SOLUTION;INJECTION - 150MG/30ML (5MG/ML)

SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)

SOLUTION;INJECTION - 1GM/200ML (5MG/ML)

SOLUTION;INJECTION - 200MG/20ML (10MG/ML)

SOLUTION;INJECTION - 200MG/100ML (2MG/ML)

SOLUTION;INJECTION - 20MG/10ML (2MG/ML)

SOLUTION;INJECTION - 400MG/200ML (2MG/ML)

SOLUTION;INJECTION - 40MG/20ML (2MG/ML)

SOLUTION;INJECTION - 500MG/100ML (5MG/ML)

SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Actylis

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow

28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

25 Finished Drug Prices

MARKET PLACE

17 APIs

2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents

14 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM

3 USP

15 Others

Filters

SOLUTION;INJECTION - 50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons