Methylphenidate HCl

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 20 USDMF, 16 CEP/COS, 1 JDMF, 4 EU WC, 8 KDMF, 20 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

FINISHED DOSAGE FORMULATIONS

411 FDF Dossiers, 262 FDA Orange Book, 111 Europe, 7 Canada, 31 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- 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL -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- 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2 EUROAPI, 1 Minakem, 6 Evonik, 8 Rochem International Inc, 20 SPI Pharma, 21 DKSH, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 8 Kirsch Pharma, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 38 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 20 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 2 Hayashibara, 13 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 3 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, 10 Sigachi Industries, 3 Silverline Chemicals, 6 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

93 Fillers, Diluents & Binders, 81 Coating Systems & Additives, 56 Thickeners and Stabilizers, 49 Controlled & Modified Release, 40 Direct Compression, 39 Taste Masking, 35 Granulation, 34 Solubilizers, 30 Topical, 30 Film Formers & Plasticizers, 29 Parenteral, 27 Disintegrants & Superdisintegrants, 26 Lubricants & Glidants, 24 Chewable & Orodispersible Aids, 12 Co-Processed Excipients, 11 Emulsifying Agents, 11 Rheology Modifiers, 9 Empty Capsules, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 70 News #PharmaBuzz

GLOBAL SALES INFORMATION

47 US Medicaid Prescriptions, 89 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

224 US Patents, 57 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 207960 / DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG

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

Inactive Ingredients

Ingredient Name	NextWave Pharmaceuticals, Inc	NextWave Pharmaceuticals, Inc.
ASPARTAME(Z0H242BBR1)
CHERRY(BUC5I9595W)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
D&C RED NO. 30(2S42T2808B)
D&C RED NO. 7(ECW0LZ41X8)
GUAR GUM(E89I1637KE)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYVINYL ACETATE(32K497ZK2U)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM POLYSTYRENE SULFONATE(1699G8679Z)
TALC(7SEV7J4R1U)
TRIACETIN(XHX3C3X673)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Methylphenidate HCl