Naloxone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 13 USDMF, 12 CEP/COS, 1 JDMF, 2 EU WC, 2 KDMF, 19 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE,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

83 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 Co-Processed Excipients, 20 Lubricants & Glidants, 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

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 237 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 76 Finished Drug Prices

MARKET PLACE

17 APIs, 10 FDF Dossiers

PATENTS & EXCLUSIVITIES

183 US Patents, 3 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 205637 / DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	6.3mg \| 4.2mg \| 2.1mg
naloxone hydrochloride dihydrate(UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	1mg \| 0.7mg \| 0.3mg

Inactive Ingredients

Ingredient Name	BioDelivery Sciences International, Inc.
.ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0)
ANHYDROUS CITRIC ACID(XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(YGX74DKE74)
DIBASIC POTASSIUM PHOSPHATE(CI71S98N1Z)
Ferric Oxide Yellow(EX438O2MRT)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(8136Y38GY5)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
Methylparaben(A2I8C7HI9T)
Polycarbophil(W25LM17A4W)
Propylene Glycol(6DC9Q167V3)
Propylparaben(Z8IX2SC1OH)
Saccharin Sodium(SB8ZUX40TY)
Sodium Benzoate(OJ245FE5EU)
Sodium Hydroxide(55X04QC32I)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU)

Drug Product Composition: Naloxone Hydrochloride