Buprenorphine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 21 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

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

177 FDF Dossiers, 99 FDA Orange Book, 37 Europe, 22 Canada, 4 South Africa, 15 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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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1 Minakem, 6 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 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, 9 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 Nippon Fine Chemical, 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, 2 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, 45 Direct Compression, 35 Disintegrants & Superdisintegrants, 35 Thickeners and Stabilizers, 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 Film Formers & Plasticizers, 13 Topical, 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

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 - 22410 / DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE HYDROCHLORIDE	2mg
NALOXONE HYDROCHLORIDE(UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	0.5mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions LLC	Almatica Pharma Inc.	Alvogen Inc.	Bryant Ranch Prepack	Dr.Reddys Laboratories Inc	Indivior Inc.	Mylan Pharmaceuticals Inc.	Quality Care Products, LLC
acesulfame potassium(23OV73Q5G9)
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
ANHYDROUS CITRIC ACID(XF417D3PSL)
BUTYL ALCOHOL(8PJ61P6TS3)
BUTYLATED HYDROXYANISOLE(REK4960K2U)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
citric acid monohydrate(2968PHW8QP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C YELLOW NO. 6(H77VEI93A8)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
MALTITOL(D65DG142WK)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYETHYLENE OXIDE 100000(V46Y6OJ5QB)
POLYETHYLENE OXIDE 200000(11628IH70O)
POLYETHYLENE OXIDE 900000(16P9295IIL)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
sodium citrate(1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)
TITANIUM DIOXIDE(15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)

Drug Product Composition: Buprenorphine Hydrochloride