Naloxone

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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

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE,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

RELATED EXCIPIENT COMPANIES

1 Minakem, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 1 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 1 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

85 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, 20 Co-Processed Excipients, 18 Chewable & Orodispersible Aids, 11 Parenteral, 8 Solubilizers, 8 Topical, 7 Film Formers & Plasticizers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

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2 US Medicaid Prescriptions, 76 Finished Drug Prices

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183 US Patents, 3 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

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USFDA APPLICATION NUMBER - 205787 / DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NALOXONE HYDROCHLORIDE(UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	0.4mg

Inactive Ingredients

Ingredient Name	kaleo, Inc.
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
WATER(059QF0KO0R)

Drug Product Composition: Naloxone

Naloxone

Naloxone

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CHEMISTRY

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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

DEVELOPMENTS

55 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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

RELATED EXCIPIENT COMPANIES

1 Minakem

4 Rochem International Inc

17 SPI Pharma

2 Seqens

1 DKSH

2 Jai Radhe Sales

1 Pharm-RX Chemical

7 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

1 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

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