Methylphenidate Hydrochloride

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- 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL -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- 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 21419 / DOSAGE - SOLUTION;ORAL - 10MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)	METHYLPHENIDATE HYDROCHLORIDE	5mg in 5 \| 10mg in 5

Inactive Ingredients

Ingredient Name	SpecGx LLC	Ascend Laboratories, LLC	Breckenridge Pharmaceutical, Inc.	Bryant Ranch Prepack	Caraco Pharmaceutical Laboratories, Ltd.	Nostrum Laboratories, Inc.	Tris Pharma Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
Glycerin(PDC6A3C0OX)
GRAPE(6X543N684K)
HYDROCHLORIC ACID(QTT17582CB)
POLYETHYLENE GLYCOL 1450(OJ4Z5Z32L4)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Setid 7b372d74 7ba7 437a Be8c 6e8335b78818 Applno 21419 Form Solution Oral Dosage 10mg 5ml - Drug Product Composition: Methylphenidate Hydrochloride