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Approved Marketing Authorisations (MA) containing Naloxone Hydrochloride in Europe. Original Data : EMA Website

Client Email

Product

Naloxone Hydrochloride
Noroxymorphone API
Buprenorphine Hydrochloride
Europe

PharmaCompass Sponsored Ads

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Temad Naloxone Hydrochloride

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xyz-pharma-m-2024-10-07

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PharmaCompass Sponsored Ads

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Naloxone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 2 EU WC, 2 KDMF, 19 NDC API, 17 Listed Suppliers, $ API Reference Price

27 API Suppliers
13 USDMF
11 CEP/COS
1 JDMF
2 EU WC
2 KDMF
19 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 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

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers, 161 FDA Orange Book, 83 Europe, 13 Canada, 16 Australia, 7 South Africa, 32 Listed Dossiers

312 FDF Dossiers
161 FDA Orange Book
83 Europe
13 Canada
16 Australia
7 South Africa
32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE, FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML), TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)
TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)
FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 1 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 10 Actylis, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 40 Direct Compression, 25 Taste Masking, 25 Controlled & Modified Release, 24 Thickeners and Stabilizers, 23 Granulation, 22 Disintegrants & Superdisintegrants, 20 Lubricants & Glidants, 19 Co-Processed Excipients, 18 Chewable & Orodispersible Aids, 12 Parenteral, 8 Solubilizers, 8 Topical, 7 Film Formers & Plasticizers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

84 Fillers, Diluents & Binders
45 Coating Systems & Additives
40 Direct Compression
25 Taste Masking
25 Controlled & Modified Release
24 Thickeners and Stabilizers
23 Granulation
22 Disintegrants & Superdisintegrants
20 Lubricants & Glidants
19 Co-Processed Excipients
18 Chewable & Orodispersible Aids
12 Parenteral
8 Solubilizers
8 Topical
7 Film Formers & Plasticizers
6 API Stability Enhancers
5 Empty Capsules
4 Emulsifying Agents
4 Vegetarian Capsules
3 Rheology Modifiers
2 Coloring Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 234 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
234 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 76 Finished Drug Prices

2 US Medicaid Prescriptions
76 Finished Drug Prices

MARKET PLACE

15 APIs, 10 FDF Dossiers

15 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

183 US Patents, 3 US Exclusivities

183 US Patents
3 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

3 EDQM
1 USP
5 Others

$ API Ref.Price (USD/KG) : 10,350 Xls

Filters

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83 All

01 2B. Braun Melsungen AG

02 1B.BRAUN MELSUNGEN AG

03 4BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

04 4EG SPA

05 1GALENICA SENESE Srl

06 5GL PHARMA GmbH

07 1Hameln Pharma Plus GmbH

08 2INDIVIOR UK LIMITED

09 4L. MOLTENI AND C. DEI F.LLI ALITTI SOCIETA' DI ESERCIZIO SPA

10 4MUNDIPHARMA PHARMACEUTIC. LLC

11 4MUNDIPHARMA PHARMACEUTIC.Srl

12 4MYLAN SPA

13 8Mepha Pharma AG

14 12Mundipharma Medical Company Hamilton,Bermuda,Basel Branch

15 1Orpha-Devel Commercial und Court Of GmbH

16 1Orpha-Devel Handels und

17 1SALF SpA

18 5SANDOZ SPA

19 2SIRTON MEDICARE Srl

20 8Sandoz Pharmaceuticals AG

21 8Spirig HealthCare AG

22 1hameln pharma plus gmbh

filter Active Ingredients Reset all filters

83 All

01 2Buprenorphine; Naloxone

02 4Buprenorphine; Naloxone Hydrochloride

03 8Naloxone

04 2Naloxone Hydrochloride

05 26Oxycodone (oxycodone) hydrochloride/naloxone hydrochloride dihydrate

06 4Oxycodone; Naloxone

07 36Oxycodoni hydrochloridum; Naloxoni hydrochloridum anhydricum

08 1naloxone hydrochloride, anhydrous

filter Dosage Form Reset all filters

83 All

01 1Buprenorphine+Naloxone 8+2Mg 7 Units' Oral Use

02 1Buprenorphine+Naloxone+0,52 Mg 7 Units' Oral Use

03 26Extended Release Tablets

04 3INJECTION / INFUSION

05 3Injection/infusion fluid, resolution

06 1Naloxone 0,4Mg 1 Unit Parenteral Use

07 1Naloxone 0,4Mg 1Ml 10 Units Parenteral Use

08 1Naloxone 0.04Mg 1 Unit Parenteral Use

09 4Oral Thin Film

10 1Oxicodone+Naloxone 10+5Mg 28 Combined Oral Use Rp

11 1Oxicodone+Naloxone 20+10Mg 28 Combined Oral Use Rp

12 1Oxicodone+Naloxone 40+20Mg 28 Combined Oral Use Rp

13 1Oxicodone+Naloxone+2,55 Mg 28 Combined Oral Use Rp

14 36Ret Tabl

15 2Blank

filter Country Reset all filters

83 All

01 37Italy

02 3Norway

03 4Portugal

04 3Sweden

05 36Switzerland

filter Brand Name Reset all filters

83 All

01 4ALGALT

02 5DOLSTIP

03 4ELATREX

04 4ELIPSODOX

05 1Naloxon B. Braun

06 1Naloxon Hameln

07 3Naloxone

08 1Naloxone B. Braun

09 1Naloxone Hameln

10 2Narcos

11 2Nexodal

12 5OXYPRONAL

13 6Oxycodon Naloxon Spirig HC

14 2Oxycodon-Naloxon-Mepha

15 2Oxycodone Naloxone Spirig HC

16 8Oxycodone-Naloxone Sandoz

17 6Oxycodone-Naloxone-Mepha

18 2Suboxone

19 4TARGIN

20 16Targin

21 4Blank

Veranova Naloxone hydrochloride

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

B. Braun Melsungen AG

Aquaexpo 2024

Not Confirmed

B. Braun Melsungen AG

Aquaexpo 2024

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Regulatory Info :

Registration Country : Sweden

Naloxone Hydrochloride

Brand Name : Naloxone B. Braun

Dosage Form : INJECTION / INFUSION

Dosage Strength : 0.4 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

hameln pharma plus gmbh

Aquaexpo 2024

Not Confirmed

hameln pharma plus gmbh

Aquaexpo 2024

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Regulatory Info :

Registration Country : Sweden

Naloxone Hydrochloride

Brand Name : Naloxone Hameln

Dosage Form : INJECTION / INFUSION

Dosage Strength : 0.4 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

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Corporate PDF

03

INDIVIOR UK LIMITED

Aquaexpo 2024

Not Confirmed

INDIVIOR UK LIMITED

Aquaexpo 2024

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Regulatory Info :

Registration Country : Italy

Buprenorphine; Naloxone

Brand Name : Suboxone

Dosage Form : Buprenorphine+Naloxone+0,52 Mg 7 Units' Oral Use

Dosage Strength : 7 sublingual CPR 2 mg + 0.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Corporate PDF

04

INDIVIOR UK LIMITED

Aquaexpo 2024

Not Confirmed

INDIVIOR UK LIMITED

Aquaexpo 2024

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Regulatory Info :

Registration Country : Italy

Buprenorphine; Naloxone

Brand Name : Suboxone

Dosage Form : Buprenorphine+Naloxone 8+2Mg 7 Units' Oral Use

Dosage Strength : 7 sublingual CPR 8 mg + 2 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

MUNDIPHARMA PHARMACEUTIC.Srl

Aquaexpo 2024

Not Confirmed

MUNDIPHARMA PHARMACEUTIC.Srl

Aquaexpo 2024

Not Confirmed

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Regulatory Info :

Registration Country : Italy

Oxycodone; Naloxone

Brand Name : Targin

Dosage Form : Oxicodone+Naloxone 10+5Mg 28 Combined Oral Use Rp

Dosage Strength : 28 cpr riv 10 mg + 5 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

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Corporate PDF

06

MUNDIPHARMA PHARMACEUTIC.Srl

Aquaexpo 2024

Not Confirmed

MUNDIPHARMA PHARMACEUTIC.Srl

Aquaexpo 2024

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Regulatory Info :

Registration Country : Italy

Oxycodone; Naloxone

Brand Name : Targin

Dosage Form : Oxicodone+Naloxone 20+10Mg 28 Combined Oral Use Rp

Dosage Strength : 28 cpr riv 20 mg + 10 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

MUNDIPHARMA PHARMACEUTIC.Srl

Aquaexpo 2024

Not Confirmed

MUNDIPHARMA PHARMACEUTIC.Srl

Aquaexpo 2024

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Regulatory Info :

Registration Country : Italy

Oxycodone; Naloxone

Brand Name : Targin

Dosage Form : Oxicodone+Naloxone 40+20Mg 28 Combined Oral Use Rp

Dosage Strength : 28 CPR 40 mg + 20 mg prolonged release

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Corporate PDF

08

Orpha-Devel Handels und

Country

Aquaexpo 2024

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Orpha-Devel Handels und

Country

Aquaexpo 2024

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Registration Country : Sweden

naloxone hydrochloride, anhydrous

Brand Name : Nexodal

Dosage Form : INJECTION / INFUSION

Dosage Strength : 0.4 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Virtual Booth

Digital Content

Website

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09

SIRTON MEDICARE Srl

Country

Aquaexpo 2024

Not Confirmed

SIRTON MEDICARE Srl

Country

Aquaexpo 2024

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Registration Country : Italy

Brand Name : Narcos

Dosage Form : Naloxone 0,4Mg 1 Unit Parenteral Use

Dosage Strength : 1 ampoule EV IM SC 0.4 mg 1 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Website

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10

SIRTON MEDICARE Srl

Country

Aquaexpo 2024

Not Confirmed

SIRTON MEDICARE Srl

Country

Aquaexpo 2024

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Registration Country : Italy

Brand Name : Narcos

Dosage Form : Naloxone 0.04Mg 1 Unit Parenteral Use

Dosage Strength : 1 ampoule EV IM SC 0.04 mg 2 ml

Packaging :

Approval Date :

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Regulatory Info :

Registration Country : Italy

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