Naltrexone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 9 USDMF, 7 CEP/COS, 2 EU WC, 6 KDMF, 44 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 23 FDA Orange Book, 14 Europe, 4 Canada, 2 South Africa, 5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 SPI Pharma, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 10 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

61 Coating Systems & Additives, 56 Fillers, Diluents & Binders, 42 Controlled & Modified Release, 25 Thickeners and Stabilizers, 24 Direct Compression, 19 Granulation, 19 Solubilizers, 15 Lubricants & Glidants, 15 Disintegrants & Superdisintegrants, 13 Co-Processed Excipients, 12 Parenteral, 12 Film Formers & Plasticizers, 12 Topical, 11 Taste Masking, 9 Empty Capsules, 7 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

47 NEWS #PharmaBuzz

47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 17 Finished Drug Prices

MARKET PLACE

16 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents

88 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 22321 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **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
MORPHINE SULFATE(UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)	MORPHINE SULFATE	100mg \| 80mg \| 60mg \| 50mg \| 30mg \| 20mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM)	NALTREXONE HYDROCHLORIDE	4mg \| 3.2mg \| 2.4mg \| 2mg \| 1.2mg \| 0.8mg

Inactive Ingredients

Ingredient Name	Pfizer Laboratories Div Pfizer Inc
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
ASCORBIC ACID(PQ6CK8PD0R)
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBUTYL SEBACATE(4W5IH7FLNY)
DIETHYL PHTHALATE(UF064M00AF)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Naltrexone Hydrochloride