Apotex brand of gabapentin

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ACTIVE PHARMA INGREDIENTS

138 API Suppliers, 34 USDMF, 26 CEP/COS, 1 JDMF, 13 EU WC, 60 KDMF, 34 NDC API, 41 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

984 FDF Dossiers, 181 FDA Orange Book, 560 Europe, 66 Canada, 51 Australia, 26 South Africa, 100 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, CAPSULE;ORAL - 300MG, CAPSULE;ORAL - 400MG, TABLET;ORAL - 300MG, TABLET;ORAL - 450MG, TABLET;ORAL - 600MG, TABLET;ORAL - 750MG, TABLET;ORAL - 900MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 5 Rochem International Inc, 25 SPI Pharma, 21 DKSH, 7 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Kirsch Pharma, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 34 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 21 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 25 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

95 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 51 Direct Compression, 47 Thickeners and Stabilizers, 38 Granulation, 37 Disintegrants & Superdisintegrants, 37 Solubilizers, 28 Taste Masking, 28 Controlled & Modified Release, 26 Chewable & Orodispersible Aids, 25 Parenteral, 24 Topical, 20 Lubricants & Glidants, 20 Film Formers & Plasticizers, 15 Co-Processed Excipients, 11 Rheology Modifiers, 10 Emulsifying Agents, 9 Empty Capsules, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 67 News #PharmaBuzz

GLOBAL SALES INFORMATION

40 US Medicaid Prescriptions, 159 Regulatory FDF Prices, 3 Annual Reports

MARKET PLACE

42 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

20 Health Canada Patents

20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 16 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

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USFDA APPLICATION NUMBER - 22544 / DOSAGE - TABLET;ORAL - 750MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GABAPENTIN(UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	600mg

Inactive Ingredients

Ingredient Name	Assertio Therapeutics, Inc.	Bryant Ranch Prepack	Unit Dose Services
COPOVIDONE K25-31(D9C330MD8B)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 14bca7cb 7af5 44bc B397 240076980c73 Applno 22544 Form Tablet Oral Dosage 750mg - Drug Product Composition: Apotex brand of gabapentin