Ropinirole Hydrochloride

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 11 USDMF, 5 CEP/COS, 4 JDMF, 6 EU WC, 5 KDMF, 9 NDC API, 11 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

251 FDF Dossiers, 138 FDA Orange Book, 89 Europe, 12 Canada, 5 South Africa, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 8 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 23 BASF, 1 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 39 Direct Compression, 34 Thickeners and Stabilizers, 32 Granulation, 31 Solubilizers, 29 Controlled & Modified Release, 24 Disintegrants & Superdisintegrants, 22 Taste Masking, 20 Film Formers & Plasticizers, 19 Parenteral, 18 Chewable & Orodispersible Aids, 17 Topical, 16 Lubricants & Glidants, 15 Co-Processed Excipients, 11 Rheology Modifiers, 10 Emulsifying Agents, 7 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

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1 News #PharmaBuzz

1 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 53 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

3 APIs

3 APIs

REF. STANDARDS & IMPURITIES

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ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20658 / DOSAGE - TABLET;ORAL - EQ 3MG 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
ROPINIROLE HYDROCHLORIDE(UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)	ROPINIROLE	1mg

Inactive Ingredients

Ingredient Name	Glaxo Wellcome SA	GlaxoSmithKline LLC	PD-Rx Pharmaceuticals, Inc.	Bryant Ranch Prepack
ALUMINUM OXIDE(LMI26O6933)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COCHINEAL(TZ8Z31B35M)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYSORBATE 80(6OZP39ZG8H)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Ropinirole Hydrochloride