Methylphenidate Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 20 USDMF, 16 CEP/COS, 1 JDMF, 6 EU WC, 8 KDMF, 22 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

608 FDF Dossiers, 262 FDA Orange Book, 232 Europe, 52 Canada, 30 South Africa, 32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 18MG, TABLET, EXTENDED RELEASE;ORAL - 27MG, TABLET, EXTENDED RELEASE;ORAL - 36MG, TABLET, EXTENDED RELEASE;ORAL - 54MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, SOLUTION;ORAL - 10MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 8 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 18 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 20 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 2 Hayashibara, 15 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 36 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 6 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 84 Coating Systems & Additives, 54 Controlled & Modified Release, 50 Thickeners and Stabilizers, 46 Direct Compression, 37 Taste Masking, 32 Solubilizers, 30 Film Formers & Plasticizers, 30 Granulation, 28 Disintegrants & Superdisintegrants, 27 Topical, 27 Parenteral, 27 Lubricants & Glidants, 22 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 10 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 70 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 150 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

191 US Patents, 6 US Exclusivities, 25 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 3 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 205831 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)	METHYLPHENIDATE HYDROCHLORIDE	10mg \| 15mg \| 20mg \| 30mg \| 40mg \| 50mg \| 60mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Actavis South Atlantic LLC	American Health Packaging	Avera McKennan Hospital	Mayne Pharma	Teva Pharmaceuticals USA, Inc.	Granules Pharmaceuticals Inc.	Rhodes Pharmaceuticals L.P.	CorePharma, LLC	Kremers Urban Pharmaceuticals Inc.	Mckesson Rxpak Inc	Unither Manufacturing, LLC
ACETONE(1364PS73AF)
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)
AMMONIA(5138Q19F1X)
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(BEI30UXK2N)
CELLULOSE ACETATE(3J2P07GVB6)
CETYL ALCOHOL(936JST6JCN)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
dibutyl sebacate(4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C Blue No. 2(L06K8R7DQK)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 5(I753WB2F1M)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
ferric oxide yellow(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(36BGF0E889)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE(FZ989GH94E)
povidone, unspecified(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SHELLAC(MB5IUD6JUA)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)
WATER(059QF0KO0R)

Drug Product Composition: Methylphenidate Hydrochloride