Buprenorphine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 21 USDMF, 16 CEP/COS, 2 JDMF, 6 EU WC, 25 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers, 99 FDA Orange Book, 37 Europe, 22 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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

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EXCIPIENTS BY APPLICATIONS

94 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 45 Direct Compression, 35 Thickeners and Stabilizers, 35 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 27 Taste Masking, 26 Granulation, 22 Co-Processed Excipients, 21 Solubilizers, 20 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 15 Parenteral, 13 Topical, 13 Film Formers & Plasticizers, 6 Emulsifying Agents, 6 Rheology Modifiers, 6 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

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 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)

Drug Product Composition: Buprenorphine Hydrochloride