Tramadol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

84 API Suppliers, 37 USDMF, 27 CEP/COS, 7 JDMF, 18 EU WC, 68 KDMF, 21 NDC API, 44 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

778 FDF Dossiers, 80 FDA Orange Book, 417 Europe, 34 Canada, 57 Australia, 42 South Africa, 148 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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG,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, 17 SPI Pharma, 2 Seqens, 10 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 34 BASF, 3 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 5 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, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

101 Fillers, Diluents & Binders, 62 Coating Systems & Additives, 49 Direct Compression, 45 Disintegrants & Superdisintegrants, 40 Controlled & Modified Release, 39 Thickeners and Stabilizers, 34 Solubilizers, 33 Granulation, 30 Lubricants & Glidants, 27 Topical, 23 Parenteral, 23 Film Formers & Plasticizers, 23 Co-Processed Excipients, 19 Taste Masking, 19 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 7 Rheology Modifiers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 63 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 387 Finished Drug Prices

MARKET PLACE

60 APIs, 27 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 1 US Exclusivities, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 8 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21692 / 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 \| 100mg

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)

Drug Product Composition: Tramadol Hydrochloride