Buprenorphine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 21 USDMF, 17 CEP/COS, 2 JDMF, 4 EU WC, 26 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

254 FDF Dossiers, 95 FDA Orange Book, 114 Europe, 23 Canada, 4 South Africa, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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, TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE, FILM;BUCCAL - EQ 0.6MG BASE, FILM;BUCCAL - EQ 0.75MG BASE, FILM;BUCCAL - EQ 0.9MG BASE, 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, 6 Rochem International Inc, 18 SPI Pharma, 8 DKSH, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Shanghai Minbiotech, 2 Pfanstiehl, 6 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 23 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 19 Microlex e.U, 2 Nippon Fine Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 41 Direct Compression, 40 Thickeners and Stabilizers, 36 Disintegrants & Superdisintegrants, 31 Granulation, 29 Taste Masking, 24 Controlled & Modified Release, 23 Solubilizers, 22 Chewable & Orodispersible Aids, 18 Parenteral, 17 Lubricants & Glidants, 15 Topical, 15 Co-Processed Excipients, 12 Film Formers & Plasticizers, 9 Rheology Modifiers, 7 Emulsifying Agents, 5 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 54 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 8 Regulatory FDF Prices

MARKET PLACE

9 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

97 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 207932 / DOSAGE - FILM;BUCCAL - EQ 0.9MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	75ug \| 900ug \| 750ug \| 600ug \| 450ug \| 300ug \| 150ug

Inactive Ingredients

Ingredient Name	BioDelivery Sciences International Inc	Endo Pharmaceuticals, Inc.
.ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0)
ALPHA-TOCOPHEROL ACETATE(9E8X80D2L0)
ANHYDROUS CITRIC ACID(XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(YGX74DKE74)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
Ferric Oxide Yellow(EX438O2MRT)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(8136Y38GY5)
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(B24JYI97VR)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
Methylparaben(A2I8C7HI9T)
Peppermint Oil(AV092KU4JH)
POLYCARBOPHIL(W25LM17A4W)
Propylene Glycol(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
Saccharin Sodium(SB8ZUX40TY)
Sodium Benzoate(OJ245FE5EU)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Drug Product Composition: Buprenorphine Hydrochloride