Buprenorphine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 20 USDMF, 16 CEP/COS, 2 JDMF, 6 EU WC, 25 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

6 API Suppliers

6 API Suppliers

FINISHED DOSAGE FORMULATIONS

171 FDF Dossiers, 99 FDA Orange Book, 37 Europe, 22 Canada, 4 South Africa, 9 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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, 17 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 2 Nippon Fine Chemical, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 19 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 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, 10 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 46 Direct Compression, 36 Disintegrants & Superdisintegrants, 35 Thickeners and Stabilizers, 30 Controlled & Modified Release, 27 Taste Masking, 26 Granulation, 22 Solubilizers, 21 Co-Processed Excipients, 20 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 15 Parenteral, 13 Topical, 13 Film Formers & Plasticizers, 6 API Stability Enhancers, 6 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

54 NEWS #PharmaBuzz

54 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

MARKET PLACE

8 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

102 US Patents

102 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 207932 / DOSAGE - FILM;BUCCAL - EQ 0.6MG 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