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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

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Pipeline Prospector Sept 2024: BMS wins landmark FDA approval for schizophrenia med; Sanofi’s Dupixent okayed for COPD

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Medetomidine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 18 USDMF, 5 JDMF, 5 EU WC, 13 KDMF, 18 NDC API, 8 VMF, 32 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 Drugs in Development

FINISHED DOSAGE FORMULATIONS

100 FDF Dossiers, 60 FDA Orange Book, 6 Europe, 15 Canada, 8 South Africa, 11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML), SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML), INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

RELATED EXCIPIENT COMPANIES

2 Actylis

2 Actylis

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 53 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices, 4 Annual Reports

MARKET PLACE

19 APIs, 7 FDF Dossiers

PATENTS & EXCLUSIVITIES

66 US Patents, 9 US Exclusivities, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Fermion Oy	Finland	FERMION OY	13810	DEXMEDETOMIDINE HYDROCHLORIDE	1998-10-30	Active	II	Complete	2021-08-31	2021-08-26
28/10/2024	Moehs Iberica	Spain	MOEHS IBERICA SL	33404	DEXMEDETOMIDINE HYDROCHLORIDE	2018-12-03	Active	II	Complete	2019-03-21	2018-12-11

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Medetomidine Hydrochloride

Medetomidine Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers

18 USDMF

5 JDMF

5 EU WC

13 KDMF

18 NDC API

8 VMF

32 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

40 Drugs in Development

FINISHED DOSAGE FORMULATIONS

100 FDF Dossiers

60 FDA Orange Book

6 Europe

15 Canada

8 South Africa

11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

RELATED EXCIPIENT COMPANIES

2 Actylis

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

53 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices

4 Annual Reports

MARKET PLACE

19 APIs

7 FDF Dossiers

PATENTS & EXCLUSIVITIES

66 US Patents

9 US Exclusivities

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP

1 Others

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