Buprenorphine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 21 USDMF, 17 CEP/COS, 2 JDMF, 4 EU WC, 26 NDC API, 22 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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 Vegetarian Capsules, 4 Coloring Agents, 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 - 20733 / DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)	buprenorphine	8mg
naloxone hydrochloride(UNII: F850569PQR) (naloxone - UNII:36B82AMQ7N)	naloxone	2mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.
ACESULFAME POTASSIUM(23OV73Q5G9)
ANHYDROUS CITRIC ACID(XF417D3PSL)
ANHYDROUS LACTOSE(3SY5LH9PMK)
citric acid monohydrate(2968PHW8QP)
FD&C YELLOW NO. 6(H77VEI93A8)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
povidone K30(U725QWY32X)
SODIUM CITRATE(1Q73Q2JULR)
STARCH, CORN(O8232NY3SJ)

Setid 6ee43a2a 07fa 4137 8903 4a0a21498ffc Applno 20733 Form Tablet Sublingual Dosage Eq 2mg Base Eq 0 5mg Base - Drug Product Composition: Buprenorphine Hydrochloride