Grunenthal Brand of Tramadol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

142 API Suppliers, 36 USDMF, 27 CEP/COS, 7 JDMF, 13 EU WC, 66 KDMF, 19 NDC API, 42 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

824 FDF Dossiers, 83 FDA Orange Book, 430 Europe, 34 Canada, 57 Australia, 69 South Africa, 151 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Evonik, 2 Rochem International Inc, 18 SPI Pharma, 12 DKSH, 1 Pharm-RX Chemical, 11 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 34 BASF, 2 CD Formulation, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 22 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 58 Coating Systems & Additives, 46 Disintegrants & Superdisintegrants, 44 Direct Compression, 39 Thickeners and Stabilizers, 38 Granulation, 36 Solubilizers, 36 Controlled & Modified Release, 29 Lubricants & Glidants, 28 Topical, 23 Parenteral, 22 Film Formers & Plasticizers, 21 Chewable & Orodispersible Aids, 20 Taste Masking, 16 Co-Processed Excipients, 12 Emulsifying Agents, 10 Rheology Modifiers, 9 Empty Capsules, 9 Surfactant & Foaming Agents, 8 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 63 News #PharmaBuzz

GLOBAL SALES INFORMATION

23 US Medicaid Prescriptions, 133 Regulatory FDF Prices

MARKET PLACE

60 APIs, 27 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 13 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 7 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21745 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **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
TRAMADOL HYDROCHLORIDE(UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)	TRAMADOL HYDROCHLORIDE	300mg

Inactive Ingredients

Ingredient Name	Janssen Pharmaceuticals, Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Patriot Pharmaceuticals, LLC	REMEDYREPACK INC.
dibutyl sebacate(4W5IH7FLNY)
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)
MAGNESIUM STEARATE(70097M6I30)
polyvinyl alcohol(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE(FZ989GH94E)
silicon dioxide(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
STARCH, CORN(O8232NY3SJ)
XANTHAN GUM(TTV12P4NEE)

Setid 6077eae6 Aea0 427f Be15 9f1b3f33db0c Applno 21745 Form Tablet Extended Release Oral Dosage 200mg - Drug Product Composition: Grunenthal Brand of Tramadol Hydrochloride