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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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

Drug Product Composition: Buprenorphine Hydrochloride