Naloxone Hydrochloride Dihydrate

ACCESS ALL DATA, CHEMISTRY

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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML), FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE,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

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 235 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 4.2MG BASE;EQ 0.7MG 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 Dihydrate